Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial
Identifieur interne : 000384 ( Main/Exploration ); précédent : 000383; suivant : 000385Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial
Auteurs : Wouter A. Moojen [Pays-Bas] ; Mark P. Arts [Pays-Bas] ; Wilco C H. Jacobs [Pays-Bas] ; Erik W. Van Zwet ; M Elske Van Den Akker-Van Marle ; Bart W. Koes [Pays-Bas] ; Carmen L A M. Vleggeert-Lankamp [Pays-Bas] ; Wilco C. Peul [Pays-Bas]Source :
- BMJ : British Medical Journal [ 1756-1833 ] ; 2013.
Abstract
Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled trial. Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands. Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized. Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression. Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time. Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001). Conclusions This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional “simple” decompression and even showed a fairly high reoperation rate after interspinous process device implantation. Trial registration Dutch Trial Register NTR1307.
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DOI: 10.1136/bmj.f6415
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Koes</name><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of General Practice, Erasmus Medical Center, Rotterdam</wicri:regionArea><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Vleggeert Lankamp, Carmen L A M" sort="Vleggeert Lankamp, Carmen L A M" uniqKey="Vleggeert Lankamp C" first="Carmen L A M" last="Vleggeert-Lankamp">Carmen L A M. Vleggeert-Lankamp</name><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurosurgery, Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Peul, Wilco C" sort="Peul, Wilco C" uniqKey="Peul W" first="Wilco C" last="Peul">Wilco C. Peul</name><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurosurgery, Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurosurgery, Medical Center Haaglanden, The Hague</wicri:regionArea><wicri:noRegion>The Hague</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">BMJ : British Medical Journal</title><title level="j" type="abbrev">BMJ</title><idno type="eISSN">1756-1833</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2013">2013</date><biblScope unit="volume">347</biblScope></imprint></series><idno type="istex">EF73E260520AB5216BF6EDC8B6CFA5B6D99824AF</idno><idno type="DOI">10.1136/bmj.f6415</idno><idno type="href">bmj-347-bmj-f6415.pdf</idno><idno type="ArticleID">moow013153</idno><idno type="local">bmj;347/nov14_5/f6415</idno></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled trial. Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands. Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized. Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression. Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time. Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001). Conclusions This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional “simple” decompression and even showed a fairly high reoperation rate after interspinous process device implantation. Trial registration Dutch Trial Register NTR1307.</div></front></TEI><affiliations><list><country><li>Pays-Bas</li></country><region><li>Hollande-Méridionale</li></region><settlement><li>Leyde</li><li>Rotterdam</li></settlement></list><tree><noCountry><name sortKey="Van Den Akker Van Marle, M Elske" sort="Van Den Akker Van Marle, M Elske" uniqKey="Van Den Akker Van Marle M" first="M Elske" last="Van Den Akker-Van Marle">M Elske Van Den Akker-Van Marle</name><name sortKey="Van Zwet, Erik W" sort="Van Zwet, Erik W" uniqKey="Van Zwet E" first="Erik W" last="Van Zwet">Erik W. Van Zwet</name></noCountry><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Moojen, Wouter A" sort="Moojen, Wouter A" uniqKey="Moojen W" first="Wouter A" last="Moojen">Wouter A. Moojen</name></region><name sortKey="Arts, Mark P" sort="Arts, Mark P" uniqKey="Arts M" first="Mark P" last="Arts">Mark P. Arts</name><name sortKey="Jacobs, Wilco C H" sort="Jacobs, Wilco C H" uniqKey="Jacobs W" first="Wilco C H" last="Jacobs">Wilco C H. Jacobs</name><name sortKey="Koes, Bart W" sort="Koes, Bart W" uniqKey="Koes B" first="Bart W" last="Koes">Bart W. Koes</name><name sortKey="Moojen, Wouter A" sort="Moojen, Wouter A" uniqKey="Moojen W" first="Wouter A" last="Moojen">Wouter A. Moojen</name><name sortKey="Moojen, Wouter A" sort="Moojen, Wouter A" uniqKey="Moojen W" first="Wouter A" last="Moojen">Wouter A. Moojen</name><name sortKey="Peul, Wilco C" sort="Peul, Wilco C" uniqKey="Peul W" first="Wilco C" last="Peul">Wilco C. Peul</name><name sortKey="Peul, Wilco C" sort="Peul, Wilco C" uniqKey="Peul W" first="Wilco C" last="Peul">Wilco C. Peul</name><name sortKey="Vleggeert Lankamp, Carmen L A M" sort="Vleggeert Lankamp, Carmen L A M" uniqKey="Vleggeert Lankamp C" first="Carmen L A M" last="Vleggeert-Lankamp">Carmen L A M. Vleggeert-Lankamp</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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