Inleiding. Onderwerp:

Onderwerp:

Soort uitspraak:

Percutane transforaminale e ndoscopische disce ctomie bij lumbale he rnia is niet conform de stand van wetensdcha p en praktijk Op 10 oktober 2006 heeft het CVZ adv ies uitgebracht omtrent de lumbale hernia-operatie v olgens de PTEDmethode. De conclusie v an het CVZ luidde dat deze methode niet conform de stand van de w etenschap en praktijk w as en daardoor niet onder de te verz ekeren prestaties viel. Naar aanleiding v an vragen hierover uit het veld heeft het CVZ onderz oek laten verrichten naar de PTED-methode voor o.a. de lumbale hernia. Met de resultaten van dit onderz oek hebben de desbetreffende w etenschappelijke verenigingen ingestemd. De resultaten van het onderz oek bevestigen het standpunt dat de PTED-methode bij een lumbale hernia niet v oldoet aan de stand van de w etenschap en praktijk. De lumbale hernia-operatie volgens de PTED-mehode valt niet onder de te verz ekeren prestaties. SpZ = standpunt Zvw

Datum:

10 juli 2008

Samenvatting:

Onde rstaand de volle dige uitspraak.

Inleiding Aanleiding Hernia nuclei pulposi

Er be staan dive rse be hande lingsmogelijkhe de n voor lumbale hernia nuclei pulposi (HNP). Aanvanke lijk ve rdie nt conse rvatief bele id de voorkeur. Bij langer aanhoude n van klachten, onhoudbare pijn e n enke le ande re indicaties is ope ratief ingrijpe n de be hande ling van ee rste keus. Open chirurgie is de goude n st andaard, e chter e r is groeie nde be langstelling voor minimaal invasie ve technie ken.

Beoordeling endoscopische hernia-oper atie in 2002

In 2002 heeft het CV Z de endoscopische hernia- operatie als gebruike lijk in de kring de r beroepsgenoten aangeme rkt.1 V oor die beoorde ling is naar de op dat mome nt gepu blice erde wetenschappe lijke literatuur geke ken, echter e r is me de door de ve rwarre nde terminologie op dit terre in, niet gedifferentieerd tusse n de verschille nde gebruikte technieken: er is gee n onde rsche id gemaakt tussen de micro-e ndosopische techniek, de posterolaterale be nadering of de transforaminale benade ring. O ok was op dat mome nt de werkwijze bij de beoorde ling van ‘ge bruikelijkhe id’ van zorg nog niet

Uitspraken www.cvz.nl – 27006612 (28069099)

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uitontwikke ld. Introductie Zorgverzekeringswet

en criterium ‘stand van de weten sch ap en prakti jk’

S indsdien is de Zorgve rzekeringswet in we rking getre den ( pe r 1 jan 2006) waarin, ter ve rvanging van het be grip ‘gebruike lijkhe id’ in de Zieke nfondswet, het criterium ‘stand van de wetenschap en praktijk’ is ge ïntroduceerd. Het CV Z heeft bij het bepalen of zorg aan dit criterium voldoet een we rkwijze ont wikkeld die de principe s van evide nce based medicine volgt.2 Nadat de be schikbare wetenschappe lijke literatuur volgens deze we rkwijze is ge orde nd e n geclassificee rd vindt besluitvorming plaats. Uitgangspu nt hie rbij is dat er minstens één studie van A1 nive au (systematische re vie w) of minstens twee studie s van A2 nive au (randomized controlled trial) beschikbaar diene n te zijn om een ondubbe lzinnige be slissing te kunne n ne men. Als derge lijke studies niet aanwezig zijn betrekt het CV Z evidence van ee n lagere orde, maar die nt ook be argumentee rd te worden waarom er geen e vide nce van ee n hoge r nive au beschikbaar is of zal kome n. M et ande re woorde n: op grond van lage re evidence kán een positie ve beslissing worde n genome n m. b.t. de stand van de wetenschap en praktijk, maar dit moet met steekhoudende argume nten omklee d zijn. V oorbee lden van derge lijke argume nten zijn me disch-ethische bezware n tegen randomisatie of bre de conse nsus in de beroe psgroe pen ove r de zorgvorm in kwestie.

Beoordeling PTED in 2006

V olgens deze we rkwijze heeft het CV Z in 2006 de percutane transforaminale endoscopische discectomie (P TED) beoordee ld. Deze interventie is beoordee ld als niet conform de ‘stand van de wetenschap en praktijk’.3 Dit standpu nt heeft veel discussie opgeroe pen. De be roe psgroe p in Nede rland kan zich weliswaar in grote lij nen in dit standpu nt vinde n: de ingre ep wordt in de re guliere zieke nhu izen niet of nauwe lijks uitgevoe rd. In enke le ZBC’s e chter, in binne n- en buitenland, vindt deze ingree p we l plaats, maar wordt na publicatie van het standpunt in 2006 niet meer vergoed. V anwe ge deze discu ssie heeft het CV Z besloten om ee n systematische re vie w te laten ve rrichten naar de ‘st and van de wetenschap en praktijk’ van de PTED bij de indicatie lumbale HNP. Omdat gebleke n is dat de transforaminale techniek ook bij de diagnose ‘we rvelkanaalstenose’ wel wordt toege past is ook deze indicatie d.m. v. een systematische re vie w in kaart gebracht; deze wordt in ee n afzonderlijk rapport besproke n.

Aand achtspunten

V oor een goe d inzicht in deze discussie is voorts het volgende van belang: betr. be roe psgroe pe n (neurochiru rge n, orthope den) zijn i.h. a. terughoude nd met ope ratief ingrijpe n bij een lumbale HNP, conform de ge ldende richtlijn (update in conce ptvorm be schikbaar),4 en conform re cent gepu blicee rde (Nede rlandse) studies. Er is immers uit wetenschappe lijk onde rzoek ge ble ken dat met een


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afwachtende houding en ade quate pijnstilling de klachten van ee n HNP in het me rendeel van de gevalle n spontaan verdwijnen. Dit kan voor patië nten een onbevre dige nde situatie opleve re n: men heeft pijn en ‘e r wordt niets ge daan’. M inimaal invasie ve chiru rgie ve rlaagt de dre mpe l tot het doe n van een ope ratie ve ingree p: er is vaak gee n narcose of opname in het ziekenhuis nodig. ZBC’s springen hierop in door het aanbie den van minimaal invasie ve operatie s. P atiënten die in Nede rland niet voor een ingree p in aanme rking kome n, wijke n uit naar bv. Duitsland, waar zij we l worde n ge operee rd.

V anuit de pakketbehee rdersvisie kan dit leide n tot nietrationeel e n ondoe lmatig ge bru ik van colle ctieve middele n: de interve ntie voldoet –we llicht- niet aan het crite rium stand van de wetenschap en praktijk (= niet rationee l) en e r is niet altijd een goede indicatie voor ope ratief ingrij pen (= niet doe lmatig).

Achtergro nd: behandeling van lumbale hernia nuclei pulposi Hernia nuclei pulposi

De hernia nu cle i pu lposi (HNP) van de lumbale we rve lkolom is een uitstulping van een discu s interve rtebralis. Door druk van de he rnia op de uittredende zenuw kan zenuwpijn met uitstraling in het bee n ontst aan. In de CBO- richtlijn waarvan de update op dit mome nt in conce pt voorligt, wordt ge sproken van ee n lumbosacraal radiculair syndroom (LRS ). Dit wordt gedefiniee rd als in de bil e n/of het been uitstrale nde pijn, vergezeld van éé n of mee rde re symptome n of ve rschij nse len die suggestief zijn voor een aandoening van ee n specifieke lumbosacrale zenuwwortel. In het mere ndee l van de ge vallen wordt dit door een HNP ve roorz aakt, soms zijn ande re oorzake n aan te wijzen, of is de oorzaak niet duide lijk.

Incidentie in Nederland

In de huisartsenpraktijk is de incide ntie van het LRS 9/1000 patiënten per j aar.4 Bij het mere ndeel van de patië nten (80%) verdwijnen de klachten na verloop van tijd met een conse rvatief bele id.5 Dit be leid bestaat uit goe de pijnstilling en activiteiten naar ve rmogen. Als de pijnklachten aanhoude n verschuift de balans naar chirurgisch ingrij pen. De pe riode van afwachten is internationaal nogal ve rschillend: in de V S en in Nederland wordt relatief sne l ge operee rd, in Enge land wordt vrij lang (6 maande n) ge wacht. In het ve rle den we rd in Nederland ge advisee rd gedu rende een pe riode van zes weke n af te wachten, e chter n. a.v. rece nt onderzoek ( o. a. Peul et al6) wordt in de nieuwe conceptrichtlijn een pe riode van minstens drie maande n ge noemd. Dit wordt ove rige ns uiterst genu ancee rd wee rge ge ven: “ een tendens naar een in opzet conse rvatieve behandeling verdient in de ee rste drie maanden de voorkeur, terwijl in de daarop volge nde drie maanden de tendens steeds sterker naar ope ratie zal zijn bij aanhoude nde

Conservatief beleid


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Oper atief in grijpen

of toenemende pijnklachten.” De winst van chiru rgie ligt vooral in de korte termij n, name lijk snellere pijnreductie. Indie n gekozen wordt voor ope ratief ingrij pen is de goude n standaard de ope n, (micro-) chiru rgische disce ctomie.4-8 Hiernaast zijn endoscopische technie ken in opkomst, waarbij de be nade ring posterolateraal/transflavaal (bv. microendoscopische disce ctomie, M ED) of transforaminaal (percutane transforaminale e ndoscopische discectomie, P TED) kan zijn. Op dit moment loopt in Nede rland een multice nter RCT waarin M ED wordt ve rge leke n met microchirurgie.8 Resultaten worde n in 2009 verwacht.

Stand aard beh andeling

Indie n chiru rgische be hande ling voor een HNP is aange wezen is de open microchirurgische technie k de standaardbehande ling. Een zorgvuldige indicatiestelling is ve reist: in het mere ndee l van de ge vallen ve rbetere n de klachten bij een conse rvatief bele id.

Nieuwe interventie

De PTED behande ling wordt onde r plaatse lijke verdoving e n in dagbe handeling uitge voe rd. De hernia wordt ge attaquee rd via het foramen interve rtebralis, het kanaal waardoor de zenuwbundel uittree dt. Er wordt ge werkt via een e ndoscoop.

Literatuuro nderzoek percutane transfo raminale endoscopische discectomie bij hernia nuclei pulposi Vraagstelling Er is een systematische literatuurre vie w uitgevoerd met als vraagstelling 1) de effectiviteit van transforaminale endoscopische chirurgie; e n 2) de effectiviteit van transforaminale endoscopische chirurgie verge leken met de ope n microdisce ctomie. Zie voor de re vie w bijlage 1. Relevan te uitkomstm aten

De primaire uitkomstmaten waren pij n-intensiteit, functione le status, globaal e rvare n effect, effecten op arbe idsparticipatie en andere uitkomsten als re cidieve n, complicaties, patiënttevre de nhe id. S tudies werde n ge ïnclu deerd in de re vie w als zij > 15 casus be schre ve n en als de follow-up duur > 6 weke n was. Omdat verwacht werd dat er we inig RCT’ s gevonde n zouden worden zijn ook controlled clinical trials e n ove rige observatione le studie s ingesloten.

Sam envatting van de resultat en Effec tivitei t P TED bij HNP overall

In totaal zijn 31 observatione le studie s ove r de e ndoscopische benade ring van ee n lumbale HNP geïncludee rd. De me diane score voor ve rbetering van pijn in het bee n of in de rug was 88% en 74%, en voor functionele status 83%. Het globale effect was in 85% bevredigend. Recidief, complicatie of re-ope ratie trad op bij 1.7, 2.8 en 7% (alle mediaan).


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Effec tivitei t P TED bij HNP vergeleken met conventionele ingreep

De effectiviteit van transforaminale e ndoscopische chirurgie verge leken met ope n microdiscectomie is onde rzocht in 1 RCT en in 5 niet-ge randomisee rde ve rge lijkende studies. Result aten uit deze studies gezamenlijk zijn als volgt: pijn redu ctie trad op bij 71 en 82%, ove rall ve rbetering bij 97 en 93%, complicatie s bij 6.7 en 0%, en re-ope ratie bij 6.7 en 3.3%. Deze verschillen tusse n de t wee technieke n waren niet statistisch significant.

RCT

De rece nt gepublicee rde RCT ve rdie nt nade re bespreking: In de RCT worden t wee ve rschille nde endoscopische technieke n (interlaminaire e n transforaminale benade ring) verge leken met de conventionele microchiru rgische techniek.9 Randomisatie bestond uit het alternere nd toe wijzen van de ene of de ande re behande ling door de studie le iding, op volgorde van aanme lding. Deze methode van randomisatie is niet erg adequ aat en ve rzwakt de methodologische kwaliteit van de studie. De keus voor interlaminair ve rsus transforaminaal hing af van de localisatie van de HNP en ande re anatomische karakteristie ken. V an de 100 endoscopisch behandelde patiënten we rde n 41 via de transforaminale toe gangsweg geope reerd. In gee n van be ide be hande lgroe pe n trade n ernstige complicatie s op. Deze toegangsweg is niet apart ge analysee rd. Er ware n gee n ve rschille n in e rnstige postoperatie ve complicatie s, re cidiefkans, pijn- e n functionele scores. Dire cte postope ratie ve pijn e n pe rce ntage milde postope ratie ve complicatie s ware n minder in de endoscopisch behandelde groe p, alsmede de periode tot we rkhe rvatting. Gege vens ove r het aant al patiënten dat we rkte, arbe idsstatus en ziekteverzuim in de pre ope ratie ve fase worde n echter niet vermeld, zodat niet du ide lijk is of de groe pe n in dit opzicht goe d ve rgelijkbaar waren bij aanvang van de studie.

Kwali tei t studies; hoe verder

Eerste RCT: goede aan zet voor verder

De beschreve n studies zijn heterogeen met betrekking tot de sele ctie van patië nten, de ope ratie-indicaties, de ge bruikte technieke n, de follow-u p duur en de (meetmethodiek van de) uitkomstmaten. De methodologische kwaliteit van de beschre ven studie s is i. h.a. matig. Uit de systematische revie w blijkt dat er we liswaar dive rse publicaties zijn versche nen ove r de endoscopische transforaminale ru gchirurgie, maar dat de kwaliteit van vrij wel al deze studie s matig is. Dit maakt een ee nduidige conclusie ove r de ve ilighe id e n effectiviteit van de techniek lastig. M et deze methodologische be pe rkingen als voorbe houd lijken e r geen belangrijke ve rschillen te be staan tusse n de endoscopische transforaminale benade ring en de open microdisce ctomie. Te genover e ventuele voorde len zoals een korte re re validatiepe riode na e ndoscopie st aan e ventuele nade len zoals ( wellicht) een groter pe rce ntage re cidieve n en re-ope ratie s. M aar ondubbelzinnige conclusie s zijn op dit mome nt niet moge lijk. E r is re cent één gerandomiseerde


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onderzoek

studie ge publicee rd, waar in methodologisch opzicht kanttekeninge n bij kunnen worden ge plaatst, en waarbij sle chts in ee n minde rhe id van de patiënten de transforaminale benade ring is toe gepast. De result aten van deze verge lijke nde studie zijn zeker interessant, met name de combinatie van gelijkwaardige effectiviteit met de gevonde n ve rschille n in we rkhe rvatting. Dit dient nade r onde rzocht te worde n in een RCT van goede methodologische kwaliteit met voldoe nde lange follow-up. V anwe ge de mee rkosten van endoscopische chiru rgie maar ook de moge lijke effecten op sne lheid van we rkhe rvatting is ee n ge lijktijdige kosten-effectiviteitsanalyse de moe ite waard.

Standpunten en richtlijnen Standpunten van buitenl andse zorgverzeker aar s/ overheidsinstan ties

CIGNA (VS ) beschou wt endoscopische technie ken bij de behande ling van lumbale HNP als experimentele zorg.10 AETNA (VS ) heeft op zijn we bsite geen standpunt over transforaminale technie k. AETNA beschouwt wel de foraminoplastie k (m.b. v. laser) e n de micro-e ndoscopische disce ctomie als expe rimenteel. De pe rcutane lumbale disce ctomie wordt wel, indien aan een aant al voorwaarden is voldaan, ve rgoe d.11 NICE (GB), G-BA en IQWIG (Duitsland) e n KCE (België) hebbe n geen standpunt inge nomen ove r transforaminale endoscopische technieke n.12-15 De NICE heeft een ‘guidance’ in voorbe reiding ove r lage rugklachten ( verwacht in de loop van 2009).

Richtlijnen in binnen- en buitenl and

De Nederlandse richtlijn LRS (multidisciplinair i.s. m. CBO) wordt op dit moment he rzien. Het conce pt ligt voor bij de wetenschappe lijke vere niginge n. Uit het concept is bove n al geciteerd. S amengevat is de multidisciplinaire we rkgroe p van mening “ dat grootschalige inzet van nieuwe technieke n op basis van voorhanden zijnd be wijs niet aan de orde is. Daarvoor dient eerst ve rde r ade qu aat onderzoek verricht te worden.” 4

Bespreking Richtlijn lumbale HNP

De behande ling van lumbale HNP is in dive rse studie s uitvoe rig onderzocht; de result aten zijn ve rwerkt in de huidige multidisciplinaire ( conce pt) richtlij n, die volgens EBROmethodiek tot stand is gekome n.16 Belangrijke punten hie ruit zijn dat in het me rendee l van de gevallen de klachten met een conse rvatief bele id ve rdwijne n, en dat er geen goe de wetenschappe lijke gronde n zijn om, indien chirurgie wordt Minimaal invasieve ove rwoge n, nieu we minimaal invasieve technieke n op grote technieken nog niet schaal ingang te doe n vinde n. De endoscopische voldoende transforaminale be nadering wordt al enige tijd toe gepast en onderbouwd bie dt naar alle waarschij nlijkhe id voordele n in de zin van Uitspraken www.cvz.nl – 27006612 (28069099)

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Ger andomiseerd onderzoek van goede kwali teit nodig

Veel expertise binnen Nederland

Innovatieloket

sne lle r herstel en we rkhervatting. O ver e ve ntuele nade len (zoals re cidiefkans en de kans op ernstige complicatie s als duralekkage) in ve rge lijking met de gouden standaard (microchirurgische discectomie) is e chter nog onvoldoe nde beke nd. Dit zou in een RCT van goede kwaliteit en met een voldoe nde lange follow-up duur (minstens 2 jaar) nade r moeten worden onderzocht. De kosten-effectiviteit t.o.v. de standaardbe hande ling die nt hie rin te worde n mee genome n. Concluderend is er op dit mome nt nog onvoldoende be wijs van hoog nive au be schikbaar betr. PTED voor de behandeling van ee n lumbale HNP. Er zijn gee n argumenten te be denken waarom ee n RCT van goe de kwaliteit niet mogelijk zou zijn: het betreft geen zeldzame aandoening, er zijn geen ethische bezware n, en e r is gee n conse nsus over de waarde van endoscopische technieke n binne n de be roe psgroe pe n. Een RCT is dus zeker niet achterhaald. Daarmee voldoet deze interve ntie niet aan het criterium zorg conform ‘de stand van de wetenschap en praktijk’. Het is mogelijk ge bleken om in Nederland goe de RCT’s op te zetten en uit te voeren betr. de chiru rgische be hande ling van lumbale HNP.6-8 Ook w.b. de PTED zou het mogelijk moeten zijn in Nederland ee n RCT uit te voere n. Het CV Z heeft niet de mogelijkheid om nieuwe, veelbe lovende interve nties die nog niet voldoe nde zijn uitge krist allisee rd, tijdelijk tot het pakket toe te laten met als doe l data te verzame len voor ee n definitief oordee l. Daarvoor st aan ande re fondsen ter beschikking. W el is re cent het ‘Innovatie loket’ opge richt, een samenwe rkingsve rband van Nza, ZonM w en CV Z, dat same n met het veld, de mogelijkhe de n kan verkennen voor het doen van ( doe lmatighe ids) onde rzoek. Cont actpe rsoon voor het CV Z is P. de Jong, [email protected].

Inho udelijke consultatie De wetenschappelijke ve re nigingen orthope die (NOV ), neurochirurgie (NV VN), alsme de de Dutch S pine S ociety (DS S ), zijn gevraagd om inhoude lijk comme ntaar te leve re n op voorliggende rapportage. Het gaat hierbij om de inbre ng van de ve renigingen vanuit wetenschappelijk pe rspe ctief. Opme rkingen die voortvloe ien uit de behartiging van beroe psbelangen die ne n dan ook buiten be schou wing te blijve n. De NOV en de DSS hebben geen inhou delijk comme ntaar en kunnen zich vinden in de conclusie ( bij lage 3 en 4). De NVVN heeft niet binne n de gestelde termijn van ruim 3 weken ge reagee rd.

Standpunt ‘stand van de wetenschap en praktijk’ De vraag of zorg voldoet aan het criterium ‘stand van de wetenschap e n praktijk’ die nt bij voorkeu r te worden be antwoord a. d.h. v ge randomisee rde studie s van voldoende Uitspraken www.cvz.nl – 27006612 (28069099)

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kwaliteit, groe psgrootte en follow-u p duur. Als deze studies niet voorhanden zijn kan op grond van lage re evide nce een positie ve beslissing worde n ge nomen mits voldoende be argumenteerd is waarom e r gee n RCT’ s (mee r) mogelijk zijn. In het geval van de lumbale HNP is het CV Z van mening dat het goe d mogelijk is om een RCT u it te voeren: het betreft geen zeldzame/leve nsbe dre igende aandoeninge n of wilsonbekwame patiënten. Er is bove ndie n binne n de beroepsgroe pen bepaald geen conse nsus over de waarde van P TED. Bove ndie n is het in Nederland goe d moge lijk gebleke n om studie s van hoog nive au uit te voeren op het gebie d van lage rugklachten (sciatica-M AS T o.a.). Om deze re dene n is het CV Z van me ning dat de PTED als be hande ling van lumbale HNP geen zorg is conform stand van de wetenschap e n praktijk.

Referenties 1. RZA 2002/189 2. CVZ rapport ‘Beoordeling stand v an de w etenschap en praktijk’. 5 nov 2007. http:// www.cvz.nl/ reso urces/ rpt0711_stand- wetenschap-enprakt ijk_tcm28-25006.pdf

3. http:// www.cvz.nl/ resources/AaZ0610%20HNP-

operat ie%20en%20lumbale%20 wervelkanaalstenose_tcm28-25161.pdf

4. http:// www.cbo.nl/p rod uct/ric ht lijnen/f older20021023121843/concept_lr s_08.pdf /view

5. Gibson JNA, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database of Systematic Revie ws 2007, Issue 1. Art. No.: CD001350. DOI: 10.1002/ 14651858.CD001350.pub4 6. Peul WC, v an Houwelingen HC, v an den Hout WB, et al. Surgery versus prolonged conserv ative treatment for sciatica. New Engl J Med 2007; 356: 2245-2256. 7. Peul WC, v an den Hout WB, Brand R, et al. Prolonged conserv ative care versus early surgery in patients w ith sciatica caused by lumbar disc herniation: tw o year results of a randomised controlled trial. BMJ, doi:10.1136/bmj.a143 (published 23 May 2008). 8. http:// www.sc iatica- mast.nl/MED 9. Ruetten S, Komp M, Merk H, Godolias G. Full-endoscopic interlaminar and transforaminal lumbar discectomy versus conventional microsurgical technique. Spine 2008; 33: 931-939. 10. http:// www.cig na.com/healt hinf o/hw226016.html#tn8229 11. http:// www.aet na.com/cpb/med ical/data/1_99/0016.html 12. http:// www. nice.org.uk/guidance/ index.jsp?actio n=byID&r=true&o=11106 13. http:// www.g-ba.de/ 14. http:// www. iq wig.de/ ind ex.2.html 15. http:// www.kce.f gov.be/?SGREF=5291 16. http:// www.cbo.nl/p rod uct/ric ht lijnen/handleid ing_eb ro/def ault_view 17. http:// www.o rthopeden.org/ m_ho me 18. http:// www. nvvn.org/ 19. http:// www.dsp ine.nl/


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Bijlage 1 Nelle nsteij n et al., 2008: Transforaminal e ndoscopic surge ry for symptomatic lumbar disc herniations. A systematic revie w.

Transf oraminal Endoscop ic Surg ery for Symptomatic Lumbar Disc Herniat io ns. A systematic revie w.

Jorm Ne lle nsteij n M D, Raymond O stelo P hD, Ronald Bartels P hD M D, W ilco Peu l PhD MD, Bare nd van Roye n PhD M D, M aurits van Tulde r PhD

J.M . Nellensteijn, EM GO Institute & Dept. of Orthopae dics, VU Unive rsity M edical Center, Amsterdam, The Netherlands R.W . Ostelo, Epidemiologist, EMGO Institute, VU Unive rsity M edical Ce nter & Institute of Health S cie nce s, V U Universit y, Amsterdam, The Netherlands W .C. Peul, Neurosurge on, Le ide n University M edical Center, The Nethe rlands R.A. Bartels, Neurosurge on, Radboud Unive rsity Nijme gen M edical Centre, The Netherlands B.J. van Royen, Orthopaedic surgeon, V U University M edical Center, Amsterdam, The Netherlands M .W. van Tulder, P rofessor of he alth technology assessme nt, Institute of Health S cience s, V U Unive rsity & EMGO Institute, VU University M edical Cente r, Amsterdam, The Netherlands Correspond ence Address correspo nd ence and rep rint request s t o M .W . v an Tulder Depart ment of Healt h Eco no mics and Healt h Techno logy Assess ment , Inst it ut e of Healt h S ciences, Facult y of Eart h and Life S ciences, VU Univ ersit y, De Boelelaan 1085, roo m U-435, 1081 HV Amst erdam,T he Net herlands; Tel: + 31 20 5986587 E-mail: mau rit s.v an.t ulder@falw .v u.nl


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ABS TRACT Study design. A systematic literature re vie w. Objective. To assess the effectivene ss of transforaminal e ndoscopic surge ry and to compare this with ope n microdisce ctomy in patie nts with symptomatic lumbar disc herniations. Summary and Backgrou nd D ata. M any minimally invasive techniques have been deve lope d and pe rforme d to treat patie nts with symptomatic lumbar disc herniations. In the last de cade s transforaminal e ndoscopic techniques have been de velope d to perform discectomy unde r dire ct view. Though good re sults after endoscopic surgical proce dure s are claimed in the literature, the evide nce has not yet bee n systematically revie we d. M ethods. W e performe d a compre hensive systematic lite rature se arch in cooperation with an expe rie nce d librarian. W e searche d the M EDLINE and EM BASE database s for rele vant literature conce rning transforaminal endoscopic su rge ry for symptomatic lumbar disc herniations up to M ay 2008. Two re vie wers inde pe nde ntly checked all retrie ve d titles and abstracts and re le vant full text article s for inclusion criteria. Inclu ded article s we re asse sse d for quality and outcomes we re extracted by the two revie we rs inde pendently. Results. One randomized controlle d trial, se ven controlle d trials and 31 obse rvational studies we re ide ntified. S tudies we re hete rogene ous regarding patient se lection, indications, operation techniques, follow up period and outcome me asure s. Ove rall, 88% of patients reported le g pain re duction and 85% reported the outcome as good or excelle nt following transforaminal e ndoscopic surgery. In the controlle d studies we found no statistically significant difference s in le g pain re duction betwee n the transforaminal endoscopic surge ry grou p (89%) and the open microdisce ctomy group (87%); overall improve ment was 84% vs. 78%, re-ope ration rate 6.8% vs. 4.7%, and complication rate 1.5% vs. 1%, respe ctive ly. There we re also no difference s between two different technique s (intradiscal vs intracanal transforaminal e ndoscopic surge ry), nor bet ween different type s of he rniations ( lateral vs. central lumbar disc herniations). Conclusions. The ove rall methodological quality of studie s that investigate the effectiveness of transforaminal endoscopic surgery for symptomatic lumbar disc herniations is poor. No differences we re found on any clinical outcome betwee n transforaminal endoscopic surge ry and ope n microdiscectomy. In orde r to compare transforaminal endoscopic surge ry for symptomatic lumbar disc herniations with open microdisce ctomy or othe r tre atments, high quality randomized controlle d trials with sufficiently large sample sizes and economic e valu ations are neede d. Key words. Lumbar disc he rniation, transforaminal, endoscopic su rge ry, minimally invasive surge ry, systematic revie w.


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Int roduct ion Surgery for lumbar disc he rniation can be classifie d into two broad categorie s: open vs. minimally invasive su rge ry and posterior vs. posterolateral approache s. M ixter & Barr in 1934 were the first authors to treat lumbar disc he rniation surgically by pe rforming an open lamine ctomy and disce ctomy.30 W ith the introdu ction of the microscope, Yasargil and Caspar refined the original lamine ctomy into open microdisce ctomy 4;44. Laminectomy and microdiscectomy are open procedu res using a posterior approach. Currently, ope n microdiscectomy is the most wide spre ad proce dure for surgical de compre ssion of radiculopathy cause d by lumbar disc herniation, but minimally invasive surge ry has gaine d a growing intere st. The conce pt of minimally invasive surge ry for lumbar disc he rniations is to provide surgical options that optimally addre ss the disc pathology without producing the iat rogenic morbidit y associated with ope n su rgical proce dure s. In the last decades e ndoscopic techniques have been de velope d to pe rform disce ctomy unde r dire ct vie w and local anaesthe sia. Kambin and Gellmann in 1973 15 in the United S tates and Hijikat a in Japan in 1975 9 inde pendently performe d a non- visu alized, pe rcutaneous ce ntral nucle otomy for the rese ction and e vacu ation of nucle ar tissue via a poste rolateral approach. In 1983, Forst & Housman re ported the dire ct visu alisation of the interverte bral disc space with a modifie d arthroscope 6. Kambin publishe d the first intraoperative discoscopic vie w of a herniated nucleus pu lposu s in 1988 14. In 1989 and 1991, S chre ibe r et al. de scribe d “ percutaneou s discoscopy” a biportal endoscopic posterolateral technique with modifie d instrume nts for dire ct vie w 38 37. In 1992, M aye r introduce d pe rcutane ous endoscopic lase r disce ctomy (PELD) combining force ps and lase r 29. W ith the further perfection of scope s (e.g. variable angled lenses and working channel for different instruments) the proce dure be came more refine d. Removal of seque stered nonmigrated fragme nts be came possible using a biportal approach 18. The conce pt of posterolateral endoscopic lumbar ne rve decompression change d from indire ct central nucle otomy (inside-out, in which fragme nts are extracted through an annu lar fenestration outside the spinal canal) to transforaminal dire ct extraction of the noncontaine d and se questere d disc fragme nts from inside the spinal canal. In this article, the technique of dire ct nucleotomy is described as intradiscal and the technique dire ctly in the spinal canal is de scribe d as intracanal technique; both are transforaminal approache s. The indications for transforaminal endoscopic tre atment be came comparable to those of hemilamine ctomy and disce ctomy 5;17;27. In order to reach the posterior part of the epidural space, the superior articu lar process of the facet joint is usu ally the obstacle. Yeung and K night used a holmium- YAG (yttrium-aluminum- garnet)- lase r to achie ve foraminoplasty for ablation of bony and soft tissue for de compre ssion and enhance d acce ss and to improve intracanal visu alization 45 22. Yeung deve lope d the comme rcially available Yeung E ndoscopic S pine S ystem (YES S ) in 1997 46 and Hoogland in 1994 deve lope d the Thomas Hoogland Endoscopic S pine S ystem (Thessys). W ith this latter system it is possible to enlarge the inte rve rtebral forame n ne ar the facet joint with spe cial re ame rs to reach intracanal extrude d and se questere d disk fragments and decompress foraminal stenosis 10. Recently, also anothe r minimally invasive technique, microendoscopic disce ctomy (M ED), has been deve lope d. In M ED a microscope is use d and the spine is approache d from a posterior dire ction and not transforaminal. Therefore this technique is not considere d in the cu rre nt systematic revie w. Endoscopic surgery for lumbar disc he rniations has been available for more than 30 ye ars, but at prese nt a systematic revie w of all re levant studies on the effective ness of transforaminal endoscopic surge ry in patie nts with symptomatic lumbar disc herniations is lacking. Uitspraken www.cvz.nl – 27006612 (28069099)

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Insert f igure 1 here (zie tab les artic le LDH) Methods Objective The obje ctive of this systematic revie w was to assess the effectivene ss of transforaminal endoscopic surge ry in patie nts with symptomatic lumbar disc herniations. The refore we formulated two main rese arch questions and two subquestions; 1) W hat is the effectivene ss of transforaminal endoscopic surge ry? 1a) W hat is the effectivene ss of the older intradiscal transforaminal technique and the more re cently de ve lope d intracanal transforaminal technique ? 1b) W hat is the effectivene ss of transforaminal e ndoscopic surge ry for the different type s of he rniations ( mere lateral herniations versus central herniations versus all types of lumbar disc he rniations) ? 2) W hat is the effectivene ss of transforaminal endoscopic surge ry compared to ope n microdisce ctomy? For this systematic revie w we used the method guidelines for systematic re views as recommende d by the Cochrane Back Revie w Group43. Below the se arch strategy, sele ction of the studie s, data extraction, methodological qu ality asse ssment, and data analysis are described in more detail. All the se steps we re performe d by two inde pendent re vie wers and du ring consensus meetings potential disagreeme nts betwee n the two revie we rs regarding the se issue s we re discu sse d. If they were not resolve d a third re vie we r was consulted. Search strategy An experie nce d librarian performe d a comprehe nsive systematic literature se arch. The M EDLINE and EM BAS E database s we re se arche d for re levant studies from 1973 to April 2008. The se arch st rategy consisted of a combination of keywords conce rning the technical proce dure and ke ywords re garding the anatomical features and pathology (Table 1). W e conducted two re vie ws, one on lumbar disc herniation and one on spinal stenosis, and combine d the se arch strategy for the se two re vie ws for efficie ncy re asons. The se keywords were use d as M ESH headings and free text words. The full se arch strategy is available upon re quest. Insert Table 1 here Selection of studies The se arch was limited to English, German and Dutch studie s, be cause the se are the language s that the re vie w authors are able to re ad and understand. Two re vie w authors inde pendently examine d all titles and abstracts that met our se arch terms and revie we d full publications, whe n ne cessary. Additionally, the refere nce sections of all primary studie s were inspected for additional reference s. Studies were include d that describe transforaminal endoscopic surge ry for adu lt patie nts with symptomatic lumbar disc herniations. As we ex pected only a limited numbe r of randomized controlled trials in this field, we also inclu ded obse rvational studies (non-randomised controlled clinical trials, cohort studies, case control studie s and retrospe ctive patie nt series). To be include d, studies had to re port on more than 15 cases, with a follow up period of more than six weeks.


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Data extraction Two revie w authors indepe ndently extracted rele vant dat a from the inclu ded studie s regarding de sign, population (e.g. age, ge nde r, du ration of complaints before surge ry, etc), type of surge ry, type of cont rol interve ntion, follow-up pe riod and outcome s. Primary outcomes that we re considere d re le vant are: pain intensity (e.g., visual analogue scale or nume rical rating scale), functional status (e.g., Roland M orris Disability S cale, O swestry S cale), global pe rce ive d effect (e.g., M cNab score, perce ntage patients improved), vocational outcome s (e.g., pe rcentage return to work, number of days of sick le ave), and other outcome s (re curre nce s, complication, re-ope ration and patient satisfaction). W e contacted primary authors whe re nece ssary for clarification of ove rlap of dat a in different articles. Methodological quality assessment Two revie w authors indepe ndently asse sse d the methodological quality of the include d studies. Controlle d trials we re asse sse d using a criteria list recomme nded by the Cochrane Back revie w grou p as listed in Table 2 43. Non-controlle d studies we re asse sse d using a modified 5 point asse ssme nt score as listed in Table 3. Disagree ments we re re solved in a conse nsu s meeting and a third re view author was consulte d if nece ssary. Insert Tables 2 and 3 here Data analysis In orde r to asse ss the effectiveness of transforaminal e ndoscopic surgery and to compare it to ope n microdisce ctomy the re sults of outcome me asu res we re extracted from the original studie s. Outcome data of some studies we re re calculated, becau se the authors of the original papers did not handle drop outs, lost to follow up and/or faile d ope rations ade quately. If a study reported se veral follow-up intervals, the outcome of the longest follow-up mome nt was used. Because of the heteroge neity of the study popu lations, technical difference s of the variou s endoscopic interventions and differences in outcome me asure s, instrume nts and follow-up mome nts, statistical pooling was not pe rformed. W e prese nt the median and range (min- max) of the results of the individual studie s for e ach outcome me asure. Results Search and selection 2513 references we re identifie d in M EDLINE and EM BAS E that were potentially rele vant for the re vie ws on lumbar disc he rniation and spinal stenosis. After che cking titles and abstracts a total of 123 full text articles we re retrie ved that we re potentially eligible for this revie w on lumbar disc he rniation. Revie wing the refere nce lists of these articles resulte d in an additional 17 studie s. S ome patient cohorts we re described in more than one article. In these case s, all article s were use d for the quality assessme nt of the study, but outcome data re porting the longest follow up was use d. After scrutinizing all full text pape rs, 39 studies reported in 45 article s were include d in this re view. S ixteen studies (41%) had a me an follow-u p of more than two ye ars. The characteristics and outcome s of the inclu ded studie s are pre se nted in Table s 4-7. Insert tables 4-7 here Ty pe of studies and methodological quality A total of six prospe ctive controlled studie s and two retrospective controlle d studies we re include d. Furthermore, 12 studies we re de signed as prospective cohort (without Uitspraken www.cvz.nl – 27006612 (28069099)

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control group) and there we re 19 retrospe ctive studie s ( also without control group). W hen it was uncle ar whethe r the study was prospective or retrospective, the study was considere d ret rospe ctive. Of the six prospective cont rolle d studies, four compared transforaminal e ndoscopic surge ry with ope n disce ctomy or microdisce ctomy. All four we re reported as randomized trials, but in three of them the method of randomization was inade quate. M ayer and Brock28 did not describe the randomization method at all, and Krappe l et al.23 and Ruetten et al.34 did not randomize but allocated patients alte rnately to transforaminal endoscopic surge ry or microdisce ctomy. Only in the study by Hermantin et al.8 randomization was adequ ately pe rforme d in 60 patie nts with non-se questere d lumbar disc herniations. This was the only study that was conside re d having a high methodological qu ality and a low risk of bias, Howe ver, the ge ne ralizability of this study is poor because patie nts with a specific type of he rniated disc we re se le cted and results are conse quently not directly transferable to all patients with lumbar disc herniations. Insert tables 8-11 here Outcomes 1) W hat is the effectiveness of transforaminal e ndoscopic surge ry? No randomized controlled trials were identifie d. Outcome s of 31 obse rvational studies are prese nted in Table 12. The me dian ove rall improve ment of le g pain (V AS ) was 88% (range 65-89%), global pe rceive d effect (M acNab) 85% (72-94%), return to work of 90%, recu rre nce rate 1.7%, complications 2.8% and re-operations 7%. Insert table12 here 1a) W hat is the effectivene ss of the older intradiscal technique and the more re cently deve lope d intracanal technique? No randomized controlled trials were identifie d. In table 13 the results of 14 studies describing the int radiscal technique and 16 studie s de scribing the intracanal technique are prese nted. The me dian leg pain improve ment (V AS) was 83% (78-88%) for the intradiscal versus 88% (65-89%) for the intracanal technique and the re sults for global perce ive d effect were (M acN ab) 85% (78-89%) versus 86% (72-93%), respe ctive ly. Other outcome s are listed in table 13. Insert table 13 here 1b) W hat is the effectivene ss of transforaminal e ndoscopic surge ry for the different types of herniations (me re lateral he rniations ve rsus ce ntral he rniations ve rsus all type s of lumbar disc he rniations) ? No randomized controlled trials were identifie d. S ix non-controlle d studies describe d surge ry for far late ral herniations, one for central he rniations and in 15 studies all types of herniations were include d. The median GPE (M acNab) was 86% (85-86%) for lateral herniations, 91% for ce ntral herniations and 83% (79-94%) for all type s of herniations. Other outcome s are listed in table 14. Insert table14 here


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2) W hat is the effectivene ss of transforaminal endoscopic surge ry compared to ope n microdisce ctomy? S ix controlle d studies (N = 720) were identifie d that compared transforaminal endoscopic to ope n microdisce ctomy. Four of them were prospe ctive and two retrospective studie s. Only one high quality, randomized controlled trial (N = 60) was ide ntified that compare d pure intradiscal technique with open laminotomy. There we re no st atistically significant difference s between the two grou ps. The pain re duction in the transforaminal endoscopic surge ry grou p was 71% vs. 82% in the ope n laminotomy group after on average 32 months follow-u p. Ove rall improve ment was 97% vs. 93%, re-ope ration rate 6.7% vs. 3.3%, and complication rate 6.7% vs. 0%, respectively. Ove rall the controlle d studies found no difference s in outcomes: leg pain reduction in the transforaminal endoscopic surge ry grou p was 89% ve rsus 87% in the ope n microdisce ctomy group, overall improveme nt (GPE) was 84% versus 78%, re-operation rate 6.8% versus 4.7%, and complication rate 1.5% versus 1.0%, respective ly (table 16). In none of the studies the re were any statistically significant difference s bet ween the interve ntion grou ps on pain improve ment and global pe rce ive d effect. Ruetten et al.34 (n=200) reported statistically significant difference s on return to work, but this was a secondary outcome and it was uncle ar how many subje cts in e ach grou p had work and if groups we re comparable re garding work status and history of work absenteeism at base line. In one study transforaminal endoscopic su rge ry was compared with the same ope ration combine d with chymopapain, and one study compared e ndoscopic surge ry with chemonucleolysis and automated discectomy ( Table 7). Insert table 15 here Disc uss io n In the curre nt re vie w all available e vidence regarding the effectivene ss of transforaminal endoscopic surge ry was ide ntified and systematically summarise d. Pain improveme nt and global pe rceive d effect (GPE) were the most frequently re ported outcome s. There we re no import ant difference s between the intradiscal technique and the intracanal technique and nor we re there any difference s for different type s of herniations. Ove rall, transforaminal endoscopic surge ry showe d similar outcome s as ope n microdisce ctomy. This study has a numbe r of limitations that should be conside red when drawing conclusions re garding the effectiveness of transforaminal e ndoscopic surge ry for lumbar disc herniations. The inclu ded studie s in this re vie w we re heterogene ous with regard to the sele ction of patie nts, the indications for surgery, the surgical techniques used, and the duration of follow u p. Furthermore, different outcome me asures we re used in the studie s and different instrume nts used for the same outcome s. Below we will elaborate on the most important sources of heterogene ity in more detail. Selection of patients Patie nt sele ction and in/exclusion criteria we re often not cle arly de scribe d. Among others, this include s physical examinations, radiological findings, the period and type of preope rative the rapie s and du ration of symptoms. In most studies, patients rece ived some type of pre ope rative conservative tre atment for a few months, but the exact content of the conse rvative tre atment was not spe cified. Also, duration of symptoms before surgery differed among studies and in some studie s patients with Uitspraken www.cvz.nl – 27006612 (28069099)

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acute onset (<2 weeks) of complaints we re also include d. In some studies only “ virgin discs” were include d, while in others a pre vious disc ope ration was not an exclusion criterion or it was not mentione d if patie nts with a pre vious disc ope ration were exclude d or not. In two studie s only recu rre nt herniations after ope n microdisce ctomy we re tre ated with transforaminal endoscopic su rge ry.3,11 S ome studies included only lateral or central he rniations whe re as othe rs inclu ded all herniations. Given this, the re is mu ch heterogene ity in patient se lection betwee n the studie s which hinde rs comparability betwee n studie s. Techniques Indications for e ndoscopic surgery have change d ove r time with the introdu ction of ne w techniques, scope s and instrume nts. Initially non-cont aine d, se questere d and central he rniations were exclusion criteria for endoscopic surge ry and L5-S1 level herniations we re not always possible to re ach as the diameter of the forame n interve rtebrale de cre ase s in the lumbar are a from cranial to caudal 33. In the earlier phase of de velopme nt of transforaminal e ndoscopic surgery, disce ctomy was performe d through a fenestration in the lateral annulus and the focu s was limited on central de bulking and re duction of intradiscal pressure. L ater, the he rnia was extracted from the spinal canal with or without an intradiscal de bulking. W hen pe rforming a foraminoplast y, enhanced acce ss can be cre ated and the L5-S 1 level can be better re ache d. W e compared the effect of discectomy performe d by the intradiscal technique with the later de ve loped int racanal technique. W e found comparable outcomes for both technique s, though indications for the intracanal technique s are wide r as patients with non-cont aine d large extraligamentou s, seque stered and ce ntral fragme nts and eve n with lateral stenosis are often include d. Far lateral he rniations occur in 3-11% of lumbar disc he rniations and usu ally cause seve re sciatic pain 1;2;31;32. S ome reports me ntioned more difficulty to asse ss an extraforaminal herniate d lumbar disc through an open procedu re and it is often associated with substantial bone re moval 25. As transforaminal endoscopic surgery is a posterolateral approach to the spine, lateral he rniations might be more e asily re ache d 42 . W ith lateral he rniations the angle of the instrume nts shou ld be steepe r and thus the insertion closer to the midline5;12. W e compare d the effect of transforaminal endoscopic surge ry for lateral herniations with ce ntral and all herniations. All outcome s were comparable. Methodological quality M ost studies had major de sign we akne sse s and the qu ality of the identifie d studies was poor, indicating that studie s had a high risk of bias. O nly one adequ ately randomized controlled trial was identifie d. In most studie s randomization was not performe d at all, not pe rforme d adequ ately or not described adequ ately. Obviously, patients and surgeons cannot be blinde d for the surgical interve ntion. Howe ve r, many other important qualit y items we re also not met by the majority of studies. Although transforaminal endoscopic surge ry for lumbar disc herniation was introduce d about 30 ye ars ago and many patie nts have unde rgone this interve ntion since its introduction, only one randomized controlle d trial with a low risk of bias has been publishe d. Only high quality, randomized controlle d trials with sufficie ntly large sample sizes comparing transforaminal e ndoscopic surge ry to othe r surgical technique s for lumbar disc he rniations can provide strong e vide nce regarding its effectivene ss. Preferably these trials should be condu cted by indepe nde nt re se arch institutes.


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Outcome measures The most frequently use d outcome me asure s in the include d studie s are the V AS score for pain and the M acN ab score for global perceive d effect. In orde r to compare the V AS score s across studie s, we calcu lated the pe rce ntage of improveme nt betwee n the postope rative and preope rative scores. The M acN ab score is a 4 point scale ranging from 1 (excellent); 2 (good), 3 (fair) to 4 (poor). In most studie s ‘excellent’ and ‘good’ we re combine d and labelle d ‘satisf actory’. Though a close inspe ction of the score ‘good’ on the M acN ab, reve als that patie nts still have occasionally ongoing symptoms, sufficient to interfere with normal work or capacity to enjoy leisure activities 26. W e considere d labe lling this as a ‘ satisfactory’ outcome was some what too positive. The refore, whene ve r possible, we prese nted the original M acN ab score s. W hile some studies use d validated outcome s (e.g. the Oswe stry Disability Questionnaire for low back pain specific functional disability) othe rs used nonvalidate d outcome s, or did not describe at all how disability and improve ment were measure d. Future trials should use valid and reliable instruments to me asure the primary outcomes. Adverse effects Recurrences Eighteen studie s re ported re curre nce rates of lumbar disc he rniations, but the definition of re currence varied. For this revie w we defined a recu rre nce as a reappe arance of a symptomatic lumbar disc he rniation at the same le ve l after a pain-free interval of longe r than one month. W hen in a study the symptomatic he rnia appe are d within a month we conside red it a re-operation. In the pre se nt revie w, we found a median recu rre nce rate of 1.7% (range 0-12%.) The re ported recu rre nce rate in the literature of open microdisce ctomy is similar with re ported ranges from 5% to 11%42. In the controlle d studies we found no significant difference in re currences betwee n the two techniques. Re-operation In the non controlle d studie s we found a me dian re-operation rate of 7% (0-27%). In the controlled studies we found no significant differences in re-ope ration pe rcentage s betwee n endoscopic transforaminal surge ry and ope n microdisce ctomy (6.8 vs. 4.7%). As in most surgical interve ntions, ade quate patie nt sele ction and accurate diagnosis seem very important. M ost common cause for re- ope rations is pe rsistent complaints due to misse d lateral bony stenosis and re mnant fragme nts16. Complications One of the sugge sted advantages of transforaminal endoscopic su rge ry compare d with ope n microdisce ctomy is a lowe r complication rate. 20 Because of the small incision and minimal internal tissue damage the re validation pe riod is suppose d to be shorter and scar tissue minimized. 21 In the curre nt revie w, we found no se ve re neurological injury and a me an pe rcent age of complications after transforaminal e ndoscopic surge ry of 2.8%. There were no difference s in se rious complications betwee n endoscopic surgery and ope n microdisce ctomy. M ost reported complications we re transient dysae sthe sia or hypae sthesia. Also disadvant age s have been reported. Transforaminal endoscopic su rge ry has a steep le arning curve that re quires patience and expe rie nce, especially for those unfamiliar with pe rcutane ous techniques. In some studie s the patie nts operated at the beginning of the le arning cu rve had worse outcome 7;13;19;39;42. S ome patients may experience local anae sthesia as a disadvantage. In three studies the ope rations we re performe d under gene ral anae sthesia34;35;40. Comprehensive pre ope rative information Uitspraken www.cvz.nl – 27006612 (28069099)

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about the intervention and pe rmanent commu nication and constant obse rvation during the ope ration is of major import ance. Future research Only randomized controlle d trials that are ade quately de signed, condu cted and reported and that have a low risk of bias will provide sufficient evide nce re garding the effectiveness of transforaminal endoscopic surgery for lumbar disk herniation. High quality, randomized controlled trials with sufficie ntly large sample sizes that compare the effectivene ss of transforaminal endoscopic surge ry with ope n microdisce ctomy for lumbar disc herniations are nee ded. The short hospital st ay, shorter re validation pe riod and e arlie r return to work may resu lt in an e conomic advantage, though this has ne ve r been e valu ated. Economic e valuations should be pe rformed alongside the se trials to asse ss the cost-effectiveness and cost-utility of transforaminal endoscopic surge ry. Conclus ion This systematic re vie w asse sse d the effectivene ss of transforaminal endoscopic surge ry. Of the 39 studies inclu ded in this re vie w, most studie s had maj or design we aknesse s and we re considere d having a high risk of bias. Only one ade quately randomized controlled trial was identifie d, but this trial had poor ge neralizability. Studies we re heterogene ous regarding patient se lection, indications, ope ration technique s, follow up pe riod and outcome me asure s. Ove rall, the studie s re ported 88% leg pain re duction and 85% re ported the outcome as satisf actory. No difference s we re found in outcome betwee n the intradiscal technique and the intracanal technique or for lateral ve rsu s ce ntral lumbar disc herniations. No significant difference s in pain, ove rall improve ment, patie nt satisfaction, re curre nce rate, complications and reope rations we re found betwee n transforaminal endoscopic su rge ry and open microdisce ctomy.

Key points  Although 39 studie s we re ide ntified, none of these studie s was a large, welldesigne d randomised controlled trial with a low risk of bias and a high gene ralizability.  The ove rall methodological qu ality of studie s that investigate the effectiveness of transforaminal endoscopic surge ry is poor and studies are heteroge neou s regarding sele ction of patie nts, indications, technique s, follow up, outcome measure s and study de sign.  The reported outcomes of transforaminal endoscopic su rge ry are 88% improveme nt on le g pain (VAS ) and 85% on global me asure of improveme nt (M acNab).  No important differences we re found in the effective ness of transforaminal endoscopic surgery as compare d to open microdisce ctomy regarding pain, global perceive d effect, patient satisf action, recu rre nce rate and re- ope rations.  In orde r to compare transforaminal endoscopic su rge ry for symptomatic lumbar disc herniations with open microdisce ctomy or othe r tre atments, high quality randomized controlle d trials with sufficie ntly large sample sizes and economic evalu ations e valu ating cost-effectivene ss are direly neede d.


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Reference List

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Abdullah AF, Ditto EW, III, Byrd EB et al. Extreme- lateral lumbar disc herniations. Clinical syndrome and spe cial problems of diagnosis. J.N eurosurg 1974;41:22934.

2.

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9.

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19

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Hoogland T, S chubert M , M iklitz B et al. Transforaminal poste rolateral endoscopic discectomy with or without the combination of a low- dose chymopapain: a prospe ctive randomized study in 280 conse cutive case s. Spine 2006;31:E890-E897.

11.

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12.

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13.

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14.

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15.

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16.

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17.

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18.

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19.

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20

20.

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21.

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23.

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35.

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37.


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22

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42.

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43.

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44.

Yasargil M . M icrosurgical ope ration for he rniated disc. Adv N eurosurg 1977;81.

45.

Yeung AT. The e volution of percutane ous spinal endoscopy and disce ctomy: state of the art. Mt Sinai J Med 2000;67:327-32.

46.

Yeung AT, Tsou PM . Posterolateral e ndoscopic excision for lumbar disc herniation: S urgical technique, outcome, and complications in 307 consecutive case s. Spine 2002;27:722-31.


23

Bijlage 2. Tabe llen e n figure n: Nelle nsteijn et al., 2008

Figure 1: different posterolateral approaches to the lumbar disc. A: the intradiscal technique, B: the intracanal technique.

Table 1:Selection of terms used in our search strategy Technical procedure

anatomical features / disorder

Endos copy

Spine

Art hros copy

Back

V ideo-Assist ed Surgery

Back pain

Surgical Procedu res, M inimally

Spinal dis eas es

Inv asiv e

Disc disp lacement

M icrosurgery

Int erv ert ebral disc

Transforaminal

displacement

Discect omy

Spinal cord co mp ressio n

Percut aneous

S ciat ica

Foraminot omy ,

Radiculop at hy

Foraminoplast y Discos co py


24

Table 2: criteria list for quality assessment of controlled studies A B C D E F G H I J K

Was the method of randomization adequate? Was the treatment allocation concealed? Were the groups similar at baseline regarding the most important prognostic indicators? Was the patient blinded to the intervention? Was the care provider blinded to the intervention Was the outcome assessor blinded to the intervention? Were co-interventions avoided or similar? Was the compliance acceptable in all groups? Was the drop out rate described and acceptable? Was the timing of the outcome assessment in all groups similar? Did the analysis include an intention to treat analysis?

A

A random (unpredictabl e) assignment sequence. Examples of adequate methods are

Y Y Y

N N N

? ? ?

Y Y Y Y Y Y

N N N N N N N N

? ? ? ? ? ?

computer generated random number table and us e of sealed opaque envelopes. Methods of alloc ation usi ng date of birth, date of admission, hospital numbers, or alternati on s hould not be r egarded as appropriate. B

Assignment generated by an independent person not res ponsible for determining the eligibility of the patients. This pers on has no i nfor mati on about the persons i ncluded in the trial and has no infl uence on the assignment sequence or on the decision about eligibility of the pati ent.

C

In order to recei ve a ' yes', groups have to be similar at baseline regarding demographic factors, duration and s everity of compl aints, perc entage of patients with neurologic symptoms , and value of main outc ome measure(s).

D

The reviewer determi nes if enough i nfor mati on about the blinding is given in order to sc ore a 'yes'.

E


F


G

Co-interventions s hould either be avoided in the trial design or similar between the index and control groups.

H

The reviewer determi nes if the compliance to the interventi ons is acceptable, bas ed on the reported intensity, duration, number and frequenc y of s essions for both the i ndex inter vention and c ontrol i nter vention(s).

I

The number of participants who were included in the study but did not complete the obser vation period or were not i ncluded i n the anal ysis mus t be described and r easons given. If the perc entage of withdr awals and drop-outs does not exceed 20% for s hort-ter m follow- up and 30% for long-term follow-up and does not l ead to subs tantial bi as a 'yes' is scored. (N.B. these percentages ar e arbitrar y, not supported by literature).

J

Timing of outc ome ass ess ment shoul d be identical for all inter vention groups and for all important outcome assess ments.

K

All randomized patients are reported/analyz ed i n the group they wer e alloc ated to by randomization for the mos t important moments of effect measurement ( minus missing val ues) irrespec tive of non-complianc e and c o-inter ventions.


25

Table 3: criteria list for quality assessment of non-controlled studies A

Patient selection/inclusion adequately described ?

Y

N

?

B C D E

Drop out rate described ? Independent assessor ? Co-interventions described ? Was the timing of the outcome assessment similar?

Y Y Y Y

N N N N

? ? ? ?

A: All the basic elements of the study population are adequately described; i.e. demography, type and level of disorder, physical and radiol ogical inclusion and exclusion criteria, pre-operative treatment and duration of dis order B: Are the patients of whom no outcome was obtained, described in quantity and reason for drop out. C: The data was assess ed by an i ndependent assess or. D: All co-inter ventions in the population during and after the operation are described. E: Timing of outc ome assess ment shoul d be more or less i dentical for all inter vention groups and for all important outcome assess ments.


26

Table 4: Prospective controlled studies St udy/ auth or M ethodol og y

M ain inc lus ion c rit eria M ain exc lus ion c rit eria

Hermant in et al. 1999 7

Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit

Randomized N=60

Ty pe/ level LDH

Int ervent ions / T ec hnique/ instrumentati on

Ty pe: Int racanal LDH

Index: A rt hroscopic microdisce ct omy

Level: S ingle lev el L2-S 1

Pu re int radiscal t echniqu e Kambin t echnique biportal: N=2

Exc lus ion c rit eria S equ est ration Prev ious su rgery ( same lev el) Cent ral or lat eral st enosis

N=30 ♂8 ♂22 mean 39 y r, range 15-66 Cont rol: Open Laminotomie N=30 ♂13 ♂17 mean 40 y r, range 18-67

Hoogland et al. 2006 11


NonRandomized (birt h dat e) N=280

Ty pe: All LDH Level: S ingle lev el L2-S 1

Exc lus ion c rit eria Obesity Prev ious su rgery ( same lev el)

randomized (Alt ernat ing) N=40

Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit Exc lus ion c rit eria S equ est ration High iliac crest

Pain ( VAS) I: pre-op.: 6,6, follow u p: 1.9, difference: 4.7 =71% C: pre-op.: 6.8, follow u p: 1.2, differen ce: 5.6 =82% Ret urn t o w ork ( mean) I: 27, C: 49 day s GPE (u nclear inst rument) I: 97%, C: 93% excellent + good PS (v ery satisfied) I: 73%, C: 67% Complic at ions I: 6.7%, C: 0% Re-operat ions I: 6.7%, C: 3.3%

Follow up I: 24 mos, 16% lost t o follow u p C: 24 mos, 16% lost t o follow up

Int radiscal & int racanal t echniqu e Thessys inst rumentation N=142 ♂50 ♂92 mean 41 y r, range 18-60

Pain leg ( VA S) I: pre-op.: 8.0, follow u p: 2.0, differen ce: 6.0 =75% C: pre-op.: 8.2, follow up: 1.9, difference: 6.3 =77% Pain b ac k (VA S) I: pre-op.: 8.2, follow u p: 2.6, differen ce: 5.6 =68% C: pre-op.: 8.2, follow u p: 2.8, differen ce: 5.4 =66% GPE (M acNab) I: 16% excellent , 33.8% good, 0.9% poor C: 63% excellent , 27% good, 0.9% poor NS PS I: 85%, C: 93% S Rec urrenc e I: 7.4%, C: 4.0% Complic at ions I: 2.1%, C: 2.2% NS Re-operat ions I: 6.1%, C: 1.6% Follow up I: range: 24-36 mos, 5% lost t o follow up C: range: 24-36 mos, 0% lost t o follow u p

Ty pe: not specified

Index: Endoscopi c t ransforaminal nu cleot omy


Pu re int radiscal t echniqu e Mat hews t echnique Sofamor-Danek endoscope N=20 ♂? ♂? mean 41 y r, range 36-54


c omment

Follow up I: mean: 31 mos ( range:19-42) , 0% lost to follow up . C: mean: 32 mos ( range: 21-42) , 0% lost t o follow up

Index: t ransforaminal endoscopic disce ct omy

Cont rol: t ransforaminal endoscopic disce ct omy combined w it h inject ion of low dose (1000U) chy mopapain. N=138 ♂44 ♂94 mean 40.3 y r, range 18-60

Krappel et al. 2001 21

Follow up: durat ion and outc ome

GPE (M acNab)

I: 16% excellent , 68% good, 0% poor C:15% excellent , 60% good, 0% poor

NS Ret urn t o w ork I: 100% , C 100% Rec urrenc e I: 5%, C 0%

27

St udy/ auth or M ethodol og y

Lee et al. 1996 24 Non randomized (Preference of surgeon) N=300


Inc lus ion c rit eria Radicu lopat hy Exc lus ion c rit eria S equ est ration

Ty pe/ level LDH

Ty pe: not specified Level: S ingle lev el L3-S 1


Cont rol: Open nu cleotomy N=20 ♂? ♂? mean 39 y r, range 25-43 Index: percu t aneou s endoscopic lase r disce ct omy ( PELD) N=100 ♂35 ♂65 Pu re int radiscal t echniqu e Kambin t echnique Cont rol 1: Chemonu cleoly sis N=100 ♂24 ♂76

M ay er and Bro ck 1993 29;30

randomizat i on not specified N=40

Ru ett en et al. 2008 35 Randomized (alt ernat ing by independent person) N=200



Exc lus ion c rit eria Not specified

c omment

Complic at ions I: 0%, C 0% Re-operat ions I: 5% , C 0% Follow up 12 mos, 0% lost t o follow u p GPE (M odifiedM acNab) I: 29%, C1: 20%, C2: 18% excellent I: 39%,C1: 35%, C2: 30% good I: 9%, C1: 18%, C2: 20% poor Ret urn t o w ork (6w ks) I: 81%, C1: 67%, C2: 66% Complic at ions I: 4%, C1: 10%, C2: 3% Re-operat ions I: 9%, C1: 18%, C2: 20%

Aut hors inclu ded N=3 pat ient s in sat isfact ory group aft er reoperat ion. T hese w ere labelled as “ adv erse effe ct s” and “ reopera-t ions” in t his rev iew

Follow up 24 mos, 0% lost t o follow u p GPE ( S /S -score)

Level: S ingle lev el L2-L5

Exc lus ion c rit eria S equ est ration Prev ious su rgery ( same lev el) Cau da sy ndrome S egment al inst ability

Inc lus ion c rit eria Radicu lopat hy Neu rological deficit

Cont rol 2: Automat ed percu t aneous discect omy N=100 ♂28 ♂72 Index: Pe rcu t aneou s endoscopic disce ct omy


Ty pe: All LDH Level: S ingle lev el L1-S 1

Pu re int radiscal t echniqu e Modified Hjikat a inst rument at ion N=20 ♂8 ♂12 mean 40 y r, range 12-55 Cont rol: Open M icrodiscect omy N=20 ♂6 ♂14 mean 42 y r, range 19-63, Index: Endoscopi c t ransforaminal and int erlaminar lumbar disce ct omy Int racanal t echniqu e YES S, Richard W olf inst rument at ion N=100 Cont rol: Open M icrodiscect omy N=100 Overall N=200 ♂116 ♂84 mean 43 y r, range 20-68


I: 70% sat isfact ory , 0% poor C: 65% satisfact ory , 15% poor Pat ient s at is fact ion I: 55%, C: 55% Rec urrenc e I: 5%, C: 0% Complic at ions I: 0%, C: 5% Re-operat ions I: 15%, C: 5%

Follow up

I: 24 mos, 8% lost t o follow up C: 24 mos, 8% lost t o follow u p

Pain leg ( VA S) I: pre-op.:75, follow up:8, difference:67 =89% C: pre-op.:71, follow u p: 9, difference: 62 =87% Pain b ac k (VA S) I: pre-op.:19, follow up:11, difference:8 =42% C: pre-op.:15, follow up: 18, difference: -3 = -8.3% Funct ional st at us (ODI) I: pre-op.:75, follow u p:20, differen ce:55=73% C: pre-op.:73, follow u p:24, differen ce:49= 67% Pat ient s at is fact ion I: 97%, C: 88%

Aut hors exclu ded N=6 from analy ses du e t o rev ision su rgery These w ere t aken int o accou nt in t his rev iew N= 41 w ere operat ed v ia a t ransforaminal endoscopic t echniqu e N=59 pat ient s w ere operat ie v ia an

28

St udy/ auth or M ethodol og y


Ty pe/ level LDH



Ret urn t o w ork (mean) I: 25 day s C:49 day s Rec urrenc e I: 6.6% C: 5.7% NS Complic at ions I: 3%, C: 12% S Re-operat ions I: 6.8% C: 11.5

c omment

S

int erlaminar endoscopic t echniqu e

Table 5: Retrospective controlled studies St udy Met hodology


Kim et al. 2007 18 su rg neu rol


All pat ient s t hat underwent t he procedures in a cert ain period

Exc lus ion c rit eria Ext raforaminal LDH Prev ious su rgery ( same lev el) S pinal st enosis S egment al inst ability S pondy lolisthesis

Lee et al. 2006 23

Inc lus ion c rit eria Radicu lopat hy

Randomly select ed patients wit h follow up > 3 years in bot h groups

Exc lus ion c rit eria St enosis S egment al inst ability

Ty pe/ level LDH


Ty pe: cent ral, paramedian and foraminal LDH

Index: Pe rcu t aneou s t ransforaminal endoscopic disce ct omy ( PT ED)


Int radiscal & int racanal t echniqu e YES S, Richard W olf inst rument at ion N=295 ♂107 ♂188 mean 35 y r, range 13-83

Follow up: durat ion and outc ome Follow up mean: 23.6 mos ( range: 18-36), I: 2.5%, C: 3.5% non responders GPE (M acNab)

Ty pe: not specified Level: S ingle lev el L4-S 1

Cont rol: Open microdisce ct omy N=607 ♂215 ♂392 mean 44 y r, range 17-80 Index: Pe rcu t aneou s endoscopic lu mbar disce ct omy ( PELD) Pu re int radiscal t echniqu e inst rument at ion not specified N=30 ♂8 ♂22 mean 40 y r, range 22-67

Comment

I: 47% excellent , 37% good, 5.4% poor C: 48% excellent , 37% good, 6.6% poor

NS Rec urrenc e I: 6.4% C: 6.8% NS Complic at ions I: 3.1% C: 2.0% NS Re-operat ions I: 9.5% C: 6.3% NS

Follow up I: mean: 38 mos ( range: 32-45) , 0% lost to follow up C: 35-42 ( 36) months, 0% non responders GPE (M acNab) I: 80% excellent , 17% good, 3.3% poor C: 78% excellent , 17% good, 0% poor Complic at ions I: 0%, C: 0% Re-operat ions I: 3.3%, C: 0%

Primary ou t come of t he stu dy w as a radiologic ev alu at ion

Cont rol: Open microdisce ct omy N= 30 ♂8 ♂22 mean 40 y r, range 20-64


29

Table 6: prospective cohort studies St udy


Hoogland et al. 2008 12

Number of part ic ipants Ty pe/ level LDH


Inc lus ion c rit eria Prev ious su rgery ( same lev el) Recu rrent disc herniat ion Radicu lopat hy Pos t ension sign Neu rological deficit Exc lus ion c rit eria Not specified

N=262 ♂76 ♂186 mean 46 y r range 18-80

Hoogland and S chenkenba c h 1998;10 S chenkenba c h and Hoogland 1999 39


N=130 ♂43 ♂87 M ean 39 y r

Endoscopic t ransforaminal disce ct omy ( ET D)

Ty pe: All LDH



Int radiscal & int racanal t echniqu e Thessys inst rumentation

Kaf adar et al. 2006 15


N=42 ♂2 ♂40 range 18-74 y r

Kambin 1992; Kambin 1998 16;17

Knight et al. 1999; Knight et al 2001 19;20

Exc lus ion c rit eria Prev ious su rgery ( same lev el) S pinal st enosis S egment al inst ability Calcified L DH Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit Exc lus ion c rit eria Large e xt raligament al LDH Prev ious su rgery ( same lev el) Cau da sy ndrome Degenerat iv e disc Inc lus ion c rit eria Prior disc su rgery n=75 Ba ck pain Leg pain

Ty pe: All LDH

Endoscopic t ransforaminal disce ct omy ( ET D) Int radiscal & int racanal t echniqu e Thessys inst rumentation


Percu t aneou s endoscopic t ransforaminal disce ct omy ( PET D)

Ty pe: All LDH Level: S ingle lev el L4-L5

N=175 ♂76 ♂99 Ty pe: All LDH

Pu re int radiscal t echniqu e Karl St orz inst rument at ion

A rt hroscopic microdisce ct omy and sele ct iv e fragment ect omy


Follow up 24 mos, 9% lost t o follow u p Pain leg ( VA S) pre-op.:8.5, follow up: 2.6, difference: 5.9 =69% Pain b ac k (VA S) pre-op.:8.6, follow u p: 2.9, differen ce: 5.7 =66% GPE (M acNab) 31% excellent , 50% good, 2.5% poor Pat ient s at is fact ion 51% excellent , 35% good, 5% poor Rec urrenc e 6.3% Complic at ions 1.1% Re-operat ions 7% Follow up 12 mos, 5.1% lost to follow up

Aut hors inclu ded only pat ient s w it h re cu rrent LDH, more t han 6 mont hs aft er open microdisce ct om y or endoscopic su rgery

Pain leg ( VA S) difference 5.9 Pain b ac k (VA S) difference 5.4 GPE (M acNab) 56% excellent , 27% good, 6% poor Ret urn t o w ork (6 w eeks ) 70% Complic at ions 1.5% Re-operat ions 4.6% Follow up mean: 15 mos( Range: 6-24) (S D: 4), 0% lost t o follow up GPE ( S /S score) 14% excellent , 36% good 36 %poor Rec urrenc e 0% Complic at ions 45% Re-operat ions 17%

Aut hors exclu ded N=8 from analy ses du e t o st opped procedu res. T hese w ere t aken into accou nt in t his rev iew

Follow up mean: 48 mos ( range: 24-78) , 3.4% lost to follow up


Pu re int radiscal t echniqu e Kambin t echnique Biportal n=59

GPE (M odified Presby .S t Lu ke score) good, 12% failed Ret urn t o w ork (3w ks) 95% Complic at ions 5.3% Re-operat ions 7.7%

N=250 ♂? ♂? mean 48y r, range 21-86

Endoscopic lase r foraminoplasty ( ELF)

Follow up mean: 30 mos ( range: 24-48) (S D5.87) , 3.2% lost t o follow u p

Int radiscal & int racanal

Pain ( VAS >50% improv ement)


Comment

56%

77% excellent , 11%

Aut hors inclu ded also degenerat iv e and lat eral

30

St udy

Lee et al. 2007 22

M orgenst ern et al. 2005 31



Radicu lopat hy

Ty pe: All LDH

Exc lus ion c rit eria Cau da sy ndrome Painless motor deficit Inc lus ion c rit eria Radicu lopat hy Neu rological deficit Non-cont ained or sequ est ered LDH

Level: single & mu lt iple lev el L2-S 1 N=116 ♂43 ♂73 mean 36 y r, range 18-65

Exc lus ion c rit eria Prev ious su rgery ( same lev el) Cent ral or lat eral st enosis S egment al inst ability


Inc lus ion c rit eria Radicu lopat hy Neu rological deficit Exc lus ion c rit eria S equ est ration

N=144 ♂48 ♂96 mean 46 y r range 18-76


Ty pe: All LDH


t echniqu e Richard W olf inst rument at ion


Funct ional st at us ( ODI) Complic at ions 0.8% Re-operat ions 5.2%

60% improv ed ≥50%

Percu t aneou s endoscopic lu mbar disce ct omy ( PELD)

Follow up mean: 14.5 mos ( range: 9-20) , 0% lost t o follow up

Int radiscal & int racanal t echniqu e YES S, Richard W olf inst rument at ion

Pain leg ( VA S) pre-op.:7.5, follow u p: 2.6, differen ce: 4.9 =65% GPE (M odifiedM acNab) 45% excellent , 47% good, 6.0% poor Ret urn t o w ork Av erage 14 day s, range 1-48 day s Rec urrenc e 0% Complic at ions 0% Re-operat ions 0% Follow up mean: 24 mos( range: 3-48) , 0%lost t o follow up

Endoscopic spine su rgery Int radiscal & int racanal t echniqu e YES S, Richard W olf inst rument at ion

GPE (M acNab) 83% excellent and good, 3% poor Complic at ions 9% Re-operat ions 5.6%

Follow up 6w eeks, 0% lost t o follow u p

Level: M ult iple lev el n=60 L1-S 1 Ramsbacher et al. 2000 33

Ru ett en et al. 2005 34

S asani et al. 2007 36

Inc lus ion c rit eria Radicu lopat hy Neu rological deficit Exc lus ion c rit eria Far migrat ed sequ est ers Cent ral or lat eral st enosis high iliac crest

N=39 ♂21 ♂18 mean 50 y r

T ransforaminal endoscopic sequ est rect omy (T ES)

Ty pe: All LDH

Int racanal t echniqu e Sofamor-Danek endoscope


N=517 ♂277 ♂240 mean 38 y r range 16-78


Exc lus ion c rit eria Far cranial/cau dal migrat ed sequ est er Prev ious su rgery ( same lev el) S pinal st enosis

Ty pe: All LDH


N=66 ♂36 ♂30 median 52 y r

Level: M ult iple lev el n=46 L1-L5

Ext reme lat eral t ransforaminal approach Int racanal t echniqu e Richard W olf inst rument at ion N=27 bilat eral

Percu t aneou s endoscopic disce ct omy ( PED)


Comment

st enosis in t his stu dy

Primary ou t come of t his stu dy w as t o compare normal v ersu s int ensiv e phy sical t herapy post operat iv e rev alidat ion

Pain leg ( VA S) pre-op.:6.7, follow u p: 0.8, difference: 5.9 =88% Pain b ac k (VA S) pre-op.:5.1, follow u p: 1.3, difference: 3.8 =74% PS 77% (v ery satisfied + sat isfied) Complic at ions 5.1% Re-operat ions 10% Follow up 12 months, 10% lost to follow up Pain leg ( VA S) pre-op.:7.1, follow up:0.8, differen ce:6.3 =89% Pain b ac k (VA S) pre-op.:1.8, follow u p:1.6, differen ce:0.2 =13% Funct ional st at us ( ODI) pre-op.:78, follow u p:20, differen ce:58=74% Rec urrenc e 6.9% Complic at ions 0% Re-operat ions 6.9% Follow up 12 months, 0% lost to follow up

31

St udy


Pos t ension sign Neu rological deficit Exc lus ion c rit eria Prev ious su rgery ( same lev el)

S chu bert and Hoogland 2005 42

Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit S equ est ration

Su ess 2005 44



range 35-73 Ty pe: Foraminal + ext raforaminal LDH Level: S ingle lev el L2-L5 N=558 ♂179 ♂379 mean 44 y r range 18-65 Ty pe: All LDH

Pu re int radiscal t echniqu e Karl St orz inst rument at ion

T ransforaminal nu cleotomy w ith foraminoplasty Int racanal t echniqu e Thessys inst rumentatuion

Exc lus ion c rit eria Prev ious su rgery ( same lev el)



N=25 ♂11 ♂14 mean 48 y r, range 26-72

Percu t aneou s t ransforaminal endoscopic sequ est rect omy ( PT FES )

Exc lus ion c rit eria Cau da sy ndrome S pinal st enosis

Ty pe: Foraminal + ext raforaminal LDH

Pu re int radiscal t echniqu e inst rument at ion not specified


Comment

Pain ( VAS) pre-op.:8.2, follow up:1.2, difference:7.0 =85% Funct ional st at us ( ODI) pre-op.:78, follow u p:8, differen ce:70=90% Complic at ions 6.1% Re-operat ions 7.6%

Follow up 12 months, 8.7% lost to follow up Pain leg ( VA S) pre-op.:8.4, follow up:1.0, difference:7.4 =88% Pain b ac k (VA S) pre-op.:8.6, follow up:1.4, difference:7.2 =84% GPE (M acNab) 51% excellent , 43% good, 0.3% poor Rec urrenc e 3.6% Complic at ions 0.7% Re-operat ions 3.6% Follow up 6w eeks, 0% lost t o follow u p Pain leg ( VA S) pre-op.:6.7, follow up:0.8, difference:5.9 =88% Pain b ac k (VA S) pre-op.:5.1, follow u p:1.3, differen ce:3.8=75% Complic at ions 4% Re-operat ions 8%

A ll pat ient s operat ed under general anaest hesia and EM G monitoring

Level: S ingle lev el L2-L5

Table 7: Retrospective cohort studies St udy


A hn et al. 2004 1

Chiu 2004

2

Ty pe/ level LDH

Inc lus ion c rit eria Prior disc su rgery Radicu lopat hy Pos t ension sign Neu rological deficit

N=43 ♂11 ♂32 mean 46 y r range 22-72

Exc lus ion c rit eria S egment al inst ability S pondy lolisthesis Calcified f ragment s Inc lus ion c rit eria V irgin and prior disc su rgery


Ty pe: All LDH

N=2000 ♂990 ♂1010

Int ervent ions / T ec hnique/ instrumentati on Percu t aneou s endoscopic lu mbar disce ct omy ( PELD) Int radiscal & int racanal t echniqu e inst rumentation not specified

T ransforaminal microde compressiv e


Follow up: durat ion and outc ome Follow up range: 24-39 months, 0% non-responders Pain ( VAS) pre-op.:8.7, follow up:2.6, difference:6.1 =70% GPE (M acNab) 28% excellent ,53% good, 4.7% poor Complic at ions 4.6% Re-operat ions 2.3%

Follow up mean: 42 mos( range: 6-72) , 0% non-responders

c omment

Aut hors inclu ded only pat ient s w it h re cu rrent LDH, more t han 6 mont hs aft er open microdisce ct om y Aut hors inclu ded also

32

St udy

M ain inc lus ion c rit eria M ain exc lus ion c rit eria Pain in back Radicu lopat hy Neu rological deficit Exc lus ion c rit eria Cau da sy ndrome Painless motor deficit

Choi et al. 2007 3

Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit Exc lus ion c rit eria Prev ious su rgery ( same lev el) Cent ral or lat eral st enosis S egment al inst ability Calcified dis c

Dit sw orth 1998 4


Ty pe/ level LDH mean 44 y r range 24-92 Ty pe: not specified Level: S ingle and mu lt iple lev el N=41♂23 ♂18 mean 59 y r range 32-74 Ty pe: Ext raforaminal LDH

Eu st acchio 2002 5

N=110 ♂40 ♂70 median 55 y r range 20->60

Haag 1999

6

Follow up: durat ion and outc ome GPE (u nclear inst rument) 94% excellent or good, 3%poor Complic at ions 1% Re-operat ions Not specified

c omment

pat ient s w it h st enosis and degenerat iv e disc disease

Int radiscal & int racanal t echniqu e Karl St orz inst rument at ion Ext raforaminal t arget ed fragment ect omy Pu re int radiscal t echniqu e YES S, Richard W olf inst rument at ion

Endoscopic t ransforaminal lu mbar disce ct omy

Follow up mean: 34 mos( range: 20-58) , 4.9% nonresponders Pain leg ( VA S) pre-op.:8.6, follow u p:1.9, differen ce:6.7 =78% Ret urn t o w ork mean: 6w eeks ( range: 4-24) Funct ional st at us ( ODI) pre-op.:66.3, follow u p:11.5, differen ce:54.8 =83% PS 92% Rec urrenc e 5.1% Complic at ions 5.1% Re-operat ions 7.7% Follow up range: 24-48 months, 0% non-responders

Int radiscal & int racanal t echniqu e Flex ible endoscope

GPE (M acNab) 91% excellent or good, 4.5% poor Rec urrenc e 0% Complic at ions 0.9% Re-operat ions 4.5%

Endoscopic percu t aneou s t ransforaminal t reat ment

Follow up mean: 35 mos( range: 15-53) , 0% non responders

Int radiscal & int racanal t echniqu e inst rumentation not specified

GPE (M acNab) 45% excellent , 27% good, 27% poor Funct ional st at us (PROLO) 71.9% excellent or good Ret urn t o w ork 94% Rec urrenc e 12% Complic at ions 9% Re-operat ions 27%

T ransforaminal endoscopic microdisce ct omy

Follow up mean: 28 mos( range: 15-26) , 9% nonresponders

Pu re int radiscal t echniqu e Sofamor Danek inst rument at ion

PS good: 66%, satisfied: 9%, poor: 25% Complic at ions 7.6% Re-operat ions 17%

Level: S ingle lev el N=122 ♂36 ♂86 median 55 y r range 18-89 Ty pe: All LDH

Exc lus ion c rit eria Cau da sy ndrome

endoscopic assist ed disce ct omy (T F-M EA D)


Ty pe: All LDH Exc lus ion c rit eria S pinal st enosis S egment al inst ability Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit


Level: M ult iple lev el n=4 L2-S 1


N=101

Exc lus ion c rit eria Discu s narrow ing Calcified dis c


Ty pe: All LDH


Aut hors exclu ded N=10 from analy ses du e t o st opped procedu res. T hese w ere t aken into accou nt in t his rev iew Aut hors exclu ded N=3 from analy ses du e t o t echnical problems du ring procedu res. T hese w ere t aken into accou nt in t his rev iew

33

St udy


Hochs chu ler 1991 8

Inc lus ion c rit eria Radicu lopat hy Exc lus ion c rit eria Prev ious operat ion ( same lev el) S equ est ration High iliac crest

Hoogland 2003 9

Inc lus ion c rit eria Not specified Exc lus ion c rit eria Not specified

Ty pe/ level LDH N=18 ♂5 ♂13 mean 31 y r range 18-55 Ty pe: not specified Level: L3-S 1 N=246 Ty pe: not specified Level: Not specified

Iprenbu rg 2007 13

Inc lus ion c rit eria Not specified Exc lus ion c rit eria Cent ral st enosis

N=149 ♂62 ♂87 mean 43 y r range 17-82 Ty pe: All LDH

Int ervent ions / T ec hnique/ instrumentati on A rt hroscopic microdisce ct omy (AM D)

14

Inc lus ion c rit eria Radicu lopat hy Exc lus ion c rit eria Prev ious su rgery ( same lev el) S egment al inst ability S pinal st enosis List hesis

Lew 2001

26

Inc lus ion c rit eria Radicu lopat hy Pos t ension sign Neu rological deficit Exc lus ion c rit eria Prev ious su rgery ( same lev el)

M ay er and Bro ck 1993 29


T ransforaminal endoscopic disce ct omy w it h foraminoplasty Int racanal t echniqu e Thessys inst rumentation

T ransforaminal endoscopic su rgery Int racanal t echniqu e Thessys inst rumentation

Exc lus ion c rit eria

T ransforaminal percu t aneous endoscopic disce ct omy (T PED)

Ty pe: Foraminal and ext raforaminal LDH

Int radiscal & int racanal t echniqu e inst rument at ion not specified

Level: S ingle lev el L2-S 1 N=47 ♂12 ♂35 mean 51 y r range 30-70

T ransforaminal percu t aneous endoscopic disce ct omy

Ty pe: Foraminal and ext raforaminal LDH

Pu re int radiscal t echniqu e Surgical dynamics inst rument at ion

Ty pe: not specified Level: M ult iple

Follow up mean: 9 mos( range: 4-13) , 0% non-responders Re-operat ions

N=35 ♂20 ♂15 mean 61 y r range 22-84

Level: L1-L5 N=30 ♂11 ♂19

c omment

11%

Pu re int radiscal t echniqu e Kambin t echnique

Level: S ingle lev el L3-S 1 J ang 2006


Percu t aneou s endoscopic lu mbar disce ct omy ( PELD) Pu re int radiscal t echniqu e inst rument at ion not specified


Follow up 24 mos, 0% non-responders GPE (M acNab) 86% excellent or good, 7.7% poor Complic at ions 1.2% Re-operat ions (1st y ear) 3.5%

Aut hors inclu ded also pat ient s w it h foraminal st enosis

Follow up not specified, 29% non-responders Pain ( VAS) not specified Funct ional st at us ( ODI) not specified Rec urrenc e 6% Complic at ions not specified Re-operat ions not specified Follow up mean: 18 mos( range: 10-35) , 0% nonresponders Pain ( VAS) pre-op.:8.6, follow up:3.2, difference:5.4 =63% GPE (M acNab) 86% excellent or good, 8.6% poor Rec urrenc e 0% Complic at ions 17% Re-operat ions 8.6%

Follow up mean: 18 mos( range: 4-51) , 0% non-responders GPE (M acNab) 85% excellent or good, 11% poor Ret urn t o w ork 89% Complic at ions 0% Re-operat ions 11%

Follow up range: 6-18 mos, 0% non-responders GPE ( S /S score) 67% excellent or good, 33% moderat e or poor Ret urn t o w ork 7.1 ± 4.2w eeks, 90% ( 6 months) Complic at ions 3.3%

20 of the pat ient s w ere desciribed in a prospect iv e stu dy 30

34

St udy


S av itz 1994; S av itz et al. 1998 37;38

S chreiber et Su ezaw a 1986; Su ezaw a and S chreiber 1988; Leu and S chreiber 1991; S chreiber and Leu 1991 25;40;41;45 S him et al 2007 43

46

Tzaan 2007 47


S equ est ration Prev ious su rgery ( same lev el) Cau da sy ndrome S egment al inst ability S pinal st enosis List hesis

lev el n=1 L2-L5


N=300 ♂132 ♂168 range 16-81 y r

Percu t aneou s lumbar disce ct omy w it h endoscope


Pu re int radiscal t echniqu e Kambin t echnique

Exc lus ion c rit eria Prev ious su rgery ( same lev el) S equ est ration Obesity Inc lus ion c rit eria Radicu lopat hy Exc lus ion c rit eria S equ est ration

Level: M ult iple lev el n=40 L2-S 1 N=174 ♂68 ♂106 mean 39 y r, range 16-81 Ty pe: not specified




N=71 ♂39 ♂32 mean 45 y r range 21-74 Ty pe: not specified Level: S ingle lev el T 12-S1 N= 219 ♂83 ♂136 mean 42 y r range 17-71

Exc lus ion c rit eria S equ est ration Prev ious operat ion ( same lev el)

Ty pe: Cent ral LDH

Inc lus ion c rit eria Pain in leg and back

N=134 ♂56 ♂78 mean 38 y r range 22-71


c omment

Re-operat ions 3.3%

Percu t aneou s nu cleot omy w ith discoscopy Pu re int radiscal t echniqu e Modified Hijikata inst rument at ion biport al

Follow up 6mos, 0% non-responders Ret urn t o w ork (6 mos) Complic at ions 5.3% Re-operat ions 1.3%

T ransforaminal endoscopic su rgery Pu re int radiscal t echniqu e YES S, Richard W olf inst rument at ion

Follow up mean: 28 mos, 0% non-responders GPE ( S /S score) 85% excellent or good Complic at ions 10% Re-operat ions 21%

Follow up mean: 6 mos ( range: 3-9), 0% non-responders GPE (M acNab) 33% excellent , 45% good, 6.5% poor Complic at ions 2.8% Re-operat ions 7.0%

T ransforaminal endoscopic decompression

Follow up mean: 20 mos( range: 12-108) , 11.9% nonresponders


GPE (M acNab) 91% excellent or good, 5.2% poor Rec urrenc e 2.7% Complic at ions 2.7% Re-operat ions 4.6%

T ransforaminal percu t aneous endoscopic lu mbar disce ct omy (T PELD)

Follow up mean: 38 mos( range: 3-36) , 0% non-responders

Exc lus ion c rit eria


GPE ( modified M acNab) poor

In this rev iew reoperat ions w ere labelled as moderat e or poor out come on GPE

67%

Level: M ult iple lev el n=25


T sou and Y eu ng 2002

Ty pe/ level LDH

Aut hors inclu ded also pat ient s w it h degenerat iv e disc disease, only t he scores from LDH a re quot ed in t his rev iew .

N=14 pat ient s w ith L5-S 1 lev el LDH a re operat ed v ia a int erlaminar approach

Possible pat ient ov erlap w it h ot her study 49

28% excellent , 61% good, 3.7%

35

St udy


W ojcik 2004 48 2004

Ty pe/ level LDH

S equ est ration S pinal st enosis Calcified dis c S egment al inst ability Cau da sy ndrome Inc lus ion c rit eria Radicu lopat hy

Ty pe: All LDH

Exc lus ion c rit eria S equ est ration Chronic ba ck pain


Level: M ult iple lev el N=20 L2-S 1 N=43 ♂25 ♂18 mean 30 y r

Level: Not specified Y eu ng and T sou 2002

49

Inc lus ion c rit eria Prior disc su rgery n=31 Radicu lopat hy Neu rological deficit Exc lus ion c rit eria S equ est ration Cent ral and lat eral st enosis

N= 307 ♂102 ♂205 mean 42 y r range 18-72 Ty pe: All LDH Level: S ingle lev el L2-S 1



c omment

Pu re int radiscal t echniqu e inst rument at ion not specified

Rec urrenc e 0.7% Complic at ions 6.0% Re-operat ions 4.5%

Endoscopically assist ed percu t aneous lumbar disce ct omy

Follow up 18 mos, 16.3% non-responders GPE (u nclear inst rument) 64% good, 36% satisfied, 0% poor Complic at ions not specified Re-operat ions not specified

Pu re int radiscal t echniqu e Modified Hijikata inst rument at ion

Post erolat eral endoscopic excision for lumbar disc herniat ion

Follow up mean: 19 mos( range: 12-?) , 8.8% nonresponders

Possible pat ient ov erlap w it h ot her study 46

GPE (M acNab) 84% excellent or good, 9.3% poor Rec urrenc e 0.7% Complic at ions 3.9% Re-operat ions 4.6%


Table 8: Methodological quality prospective controlled studies St udy

A

B

C

D

E

F

G

H

I

J

K

Risk of bias

Hermant in et al.1999

7

1

1

1

0

0

1

1

1

1

?

1

Low

Ho o gland et al. 2006 1 1

0

0

1

0

0

0

0

1

1

1

1

High

Krappel et al. 2001 2 1

0

0

?

0

0

0

?

1

0

1

0

High

0

0

?

0

0

0

?

?

1

1

1

High

?

?

1

0

0

0

?

?

1

1

1

High

0

0

?

0

0

0

?

1

1

1

1

High

Lee et al. 1996 2 4 M ayer and Bro ck 1993 Ruett en et al. 2008

2 9 ;30

35


36

Table 9: Methodological quality retrospective controlled studies St udy

A

B

C

D

E

F

G

H

I

J

K

Risk of bias

Kim et al. 2007 1 8

0

0

0

0

0

0

?

?

1

0

0

High

Lee et al. 2006 2 3

0

0

1

0

0

0

0

?

1

1

0

High


37

Table 10: Methodological quality prospective cohort studies St udy

A

B

C

D

E

Risk of bias

Ho o gland et al. 2008

12

Ho o gland and Sche nkenbach 1999

1 0 ;39

1

1

0

0

1

High

0

0

0

0

1

High

Kaf adar et al. 2006

15

1

1

0

1

0

High

Kambi n et al. 1998

1 6 ;17

0

1

0

0

1

High

1

1

0

0

1

High

Lee et al. 2007 2 2

1

1

0

0

0

High

M o rgenst ern et al. 2005 3 1

0

1

0

1

0

High

33

0

1

0

0

1

High

1

1

0

1

1

Low

0

1

0

0

1

High

Schubert and Ho o gland 2005 4 2

0

1

0

0

1

High

Suess et al. 2005 4 4

0

1

0

0

1

High

E

Qualit y

Knight et al. 2001

1 9 ;20

Ramsbacher et al. 2000 Ruett en et al. 2005 Sasani et al. 2007

34

36

Table 11: Methodological quality retrospective cohort studies St udy

A

B

C

D

rat ing 1

Ahn et al. 2004

0

1

0

0

1

High

1

?

0

0

0

High

1

1

0

0

0

High

1

1

0

0

1

High

1

1

0

0

0

High

0

1

0

0

0

High

Ho chschuler 19918

0

1

0

0

0

High

Ho o gland 20039

0

?

0

1

1

High

Chiu 2004

2

3

Cho i et al. 2007

4

Ditswo rt h 1998

Eust acchio et al. 2002 Haag 1999

5

6

Ipre nburg 2007

13

0

0

0

0

?

High

J ang et al. 2006

14

0

1

0

1

0

High

0

1

0

0

0

High

0

?

0

0

0

High

Sav it z et al. 1998 3 7 ;38

0

?

0

0

1

High

Schreibe r et al. 1991 2 5 ;40 ;41 ;45

0

0

0

0

0

High

0

1

0

0

0

High

1

1

0

0

1

High

0

1

0

0

0

High

0

0

0

0

1

High

1

0

0

0

0

High

Lew et al. 2001

26

M ayer and Bro ck 1993

29

43

Shim et al. 2007

Tso u and Yeung 2002 Tzaan 2007

47

Wo jcik 2004

48

Yeung and Tso u 2002

46

49


38

Table 12: Overall outcome, non-controlled studies Outcome measure

St udies

(inst rument )

(patient s)

Outcome median (min-max)

Pain leg (VAS)

7 (n=1558)

88% (65-89%) improv ement

Pain bac k (VAS)

5 (n=1401)


Pain

(region

not 3 (n=144)


specified)(VAS) GPE (Mc Nab)

15 (n=2544)

85% (72-94%) satisfac tory 6% (0.3-27%) poor

Func tional status (ODI)

3 (n=624)


Patient satisfac tion

3 (n=181)

78% (75-92%) satisfac tory

Return to work

5 (n=757)

90% (67-95%)

Rec urrence

13 (n=2612)

1.7% (0-12%)

Complic ation

28 (n=6336)

2.8% (0-40%)

Re-operation

28 (n=4135)

7% (0-27%)


39

Table 13: Intradiscal and intracanal techniques, outcomes non controlled studies Pure intradisc al technique 14 studies (n=1267)Intradisc al technique Outcome measure

St udies


(inst rument ) Pain leg (VAS)

2 (n=66)


Pain bac k (VAS)

1 (n=25)

75% improvement

Pain (region not

1 (n=66)

85% improvement

3 (n=279)


specified) (VAS) GPE (Mac Nab)

6.5% (3.7-11%) poor Rec urrence

3 (n=217)

0.7% (0-5.1%)

Complic ation

12 (n=1206)

5.3 % (0-40%)

Re-operation

14 (n=1267)

7.5% (1.3-30%)

Intrac anal tec hnique 16 studies (n=4985) Outcome measure

St udies



5 (n=1524)


Pain bac k (VAS)

4 (n=1408)


Pain (region not

2 (n=78)


12 (n=2292)



6% (0.3-9.3%) poor Rec urrence

10 (n=2395)

3.2% (0-12%)

Complic ation

17 (n=5362)

2.1% (0-17%)

Re-operation

15 (n=3098)

4.6% (0-27%)


40

Table 14: Outcomes of improvement in lateral herniations, central herniations and all types of herniations; Ty pe: far lateral LDH 6 studies (n=214) Outcome measure

St udies


(inst rument ) Pain

(region

not

4 (n=167)


2 (n=52)



9.8% (8.6-11%) poor Func tional status (ODI) Rec urrence

2 (n=76)

2.6% (0-5.1%)

Complic ation

5 (n=214)

5.1% (0-17%)

Re-operation

5 (n=214)

8.0% (7.6-11%)

Ty pe: central LDH 1 study (n=71) Outcome measure

St udies


(inst rument ) GPE (Mac Nab)

1 (n=71)

91% satisfac tory 12% poor

Complic ation

1 (n=71)

2.7%

Re-operation

1 (n=71)

4.6%

Ty pe: all LDH 15 studies (n=3067) Outcome measure

St udies



4 (n=1374)


Pain bac k (VAS)

4 (n=1374)


Pain (region not

1 (n=43)

70% improvement

9 (n=1810)



4.6% (0.3-9.3%) poor Rec urrence

9 (n=2201)

3.6% (0-12%)

Complic ation

15 (n=2934)

4.9% (0-45%)

Re-operation

15 (n=2934)

5.6% (2.3-27%)


41

Table 16: outcomes of improvement of transforaminal endoscopic versus open microdiscectomy Endoscopic (index) vs open mic rodiscec tomy (c ontrol), Outcome measure

St udies


(inst rument ) Pain leg(VAS)

1 (n=200)

Index 89% improv ement Cont rol 87% improv ement

Pain bac k (VAS)

1 (n=200)

Index 42% improv ement Cont rol -8.3% improv ement

Pain (region not specified) 1 (n=60)

Index 71% improv ement

(VAS)

Cont rol 82% improv ement

GPE (Mac Nab/other)

5

Index

84%

(n=1102)

satisfac tory

(70-97%)

1.7% (0-5.4%) poor Cont rol

78%

(65-93%)

satisfac tory 3.3%(0-15%) poor Rec urrences Complic ations Re-operations

4

Index 5.7% (5-6.6%)

(n=1182)

Cont rol 2.9% (0-6.8%)

6

Index 1.5% (0-6.7%)

(n=1302)

Cont rol 1.0% (0-12%)

6

Index 6.8% (3.3-15%)

(n=1302)

Cont rol 4.7 % (0-11.5%)


42

Abbreviations and explanatory word list: I: index inte rve ntion C: control interve ntion LDH: Lumbar disc he rniation Type: in transversal se ction, subdivide d in central, parame dian, foraminal and extraforaminal herniations Intervent io n: as quoted in original article Pos tens io n s igns: positive tension signs(straight leg raising test or controlateral straight le g raising test) Outcomes S: statistically significant NS: not statistically significant PS: Patient S atisfaction MacNab: M acNab score as de scribe d by M acNab28 The sum of ‘excellent’ and ‘good’ outcomes are labe lle d ‘satisfactory’ GPE: global pe rceived effect S/S-score: Suezawa and S chre ibe r score 29 Presby. St Luke score: Rush-Pre sbyterian-S t. Luke score16 ODI: Oswe stry disability index 27 PROLO: Prolo functional-economic outcome rating scale32

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