Efficacy and safety of interspinous process device compared with alone decompression for lumbar spinal stenosis: A systematic review and meta-analysis.

ABSTRACT

STUDY DESIGN: Systematic review and meta-analysis. BACKGROUND: Interspinous process devices (IPD) were used as a treatment in selected patients with lumbar spinal stenosis (LSS). However, the use of IPD was still debated that it had significantly higher reoperation rates compared to traditional decompression. Therefore, the purpose of the meta-analysis was to evaluate the effectiveness and safety of IPD treatment in comparison to traditional treatment. METHODS: The databases were searched of PubMed, Embase and the Cochrane, Chinese National Knowledge Infrastructure, Chongqing VIP Database and Wan Fang Database up to January 2024. Relevant studies were identified by using specific eligibility criteria and data was extracted and analyzed based on primary and secondary endpoints. RESULTS: A total of 13 studies were included (5 RCTs and 8 retrospective studies). There was no significant difference of Oswestey Disability Index (ODI) score in the last follow-up (MD = -3.81, 95% CI -8.91-1.28, P = .14). There was significant difference of Visual Analog Scale (VAS) back pain scoring in the last follow-up (MD = -1.59, 95% CI -3.09--0.09, P = .04), but there existed no significant difference of leg pain in the last follow-up (MD = -2.35, 95% CI -6.15-1.45, P = .23). What's more, operation time, bleeding loss, total complications and reoperation rate had no significant difference. However, IPD had higher device problems (odds ratio [OR] = 9.00, 95% CI 2.39-33.91, P = .001) and lesser dural tears (OR = 0.32, 95% CI 0.15-0.67, P = .002) compared to traditional decompression. CONCLUSION: Although IPD had lower back pain score and lower dural tears compared with traditional decompression, current evidence indicated no superiority for patient-reported outcomes for IPD compared with alone decompression treatment. However, these findings needed to be verified in further by multicenter, double-blind and large sample RCTs.