Objectives: The present study performed a meta-analysis to evaluate the efficacy and safety of interspinous process distraction device (IPD) compared with open decompression surgery (ODS) in treating lumbar spinal stenosis.
Methods: Literatures were searched in the databases including Cochrane Library, Pubmed, OvidSP, Sciencedirect, Web of Science, and Springerlin. Published reviews were checked to track missed original research papers. The quality and bias of publications with randomized controlled trial were evaluated using the tool for assessing risk of bias in the Cochrane handbook. The quality and bias of publications with cohort trial were evaluated using the Newcastle-Ottawa Scale. The grades of literatures were evaluated with the guidelines of Grading of Recommendations Assessment Development and Evaluation (GRADE).
Results: Totally, 21 publications matched the inclusion criteria, including 20 different clinical trials and 54,138 patients. The results indicated that there was no significant difference in improvement rate, Oswestry disability index questionnaire (ODI) score, and visual analog scale (VAS) score of back pain or leg pain between IPD group and ODS group. The postoperation complication rate, perioperation blood loss, hospitalization time, and operation time were lower/shorter in IPD group than ODS group. However, the reoperation rate in IPD group was higher than ODS group.
Conclusion: The results indicated that IPD has better effects and less complication than ODS. However, because of the higher reoperation rate in IPD than ODS, we failed to conclude that IPD could replace ODS as golden standard but may be a viable alternative in treating lumbar spinal stenosis.
Keywords: effectiveness; interspinous process distraction device; lumbar spinal stenosis; meta-analysis; open decompression surgery; safety.