• Bo Han, Yuxiang Chen, Weishi Liang, Yihan Yang, Zihao Ding, Peng Yin, and Yong Hai.
• Department of Orthopedic, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gong Ti Nan Road, Beijing, Chaoyang District, 100020, China.
• Eur Spine J. 2024 Mar 1; 33 (3): 881891881-891.

Background ContextLumbar spinal stenosis is one of the most common diseases affecting the elderly that is characterized by the narrowing of the spinal canal and peripheral neural pathways which may cause back pain and neurogenic intermittent claudication in affected patients. Recently, as an alternative treatment between conservative therapy and decompression surgery, interspinous process device (IPD) such as X-stop, Coflex, DIAM, Aperius, Wallis, etc., has gained enough popularity.PurposeThe purpose of this study was to evaluate the efficacy and safety of IPD in the treatment of degenerative lumbar spinal stenosis compared with decompression surgery.Study DesignThis study was a systematic review and meta-analysis of randomized controlled trials.Patient Sample555 patients' samples were collected for this study.Outcome MeasuresThe Visual Analogue Scale and the Oswestry Disability Index were analyzed, as well as the Zurich Claudication Questionnaire For efficacy evaluation. Complication and reoperation rate was utilized for the assessment of safety.MethodsA comprehensive literature search was performed through Pubmed, EMBASE, Web of Science, and Cochrane Library until October 2023. Among the studies meeting the eligible criteria, any study in which IPD was utilized in the treatment of degenerative lumbar spinal stenosis was included in the current review. For efficacy evaluation, the Visual Analogue Scale and the Oswestry Disability Index were analyzed, as well as the Zurich Claudication Questionnaire. Complication and reoperation rates were utilized for the assessment of safety.ResultsFive randomized controlled trials with 555 patients were included. There were no significant differences in VAS leg pain (SMD - 0.08, 95% CI - 0.32 to 0.15) and back pain (SMD 0.09, 95%CI-0.27 to 0.45), ODI scores (MD 1.08, 95% CI - 11.23 to 13.39) and ZCQ physical function (MD-0.09, 95% CI-0.22 to 0.05) for IPD compared with decompression surgery. In terms of ZCQ symptom severity (MD - 0.22, 95% CI - 0.27 to - 016), decompression surgery showed superior to the IPD. As for complications (RR 1.08, 95% CI 0.36 to 3.27), the IPD had no advantages compared to decompression surgery, whereas inferior to it in reoperation rate (RR 2.58, 95% CI 1.67 to 3.96).ConclusionsThis systematic review and meta-analysis indicated no superiority in the clinical outcome for IPD compared with decompression surgery. However, more clinical studies are warranted to determine the efficacy and safety of IPD.© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

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