Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis

作者：Domagoj Coric, Ahmad Nassr, Paul K. Kim, William C. Welch, Stephen E. Robbins, Steven DeLuca, Donald Whiting, Ali Chahlavi, Stephen M. Pirris, Michael W. Groff, John H. Chi, Jason H. Huang, Roland Kent, Robert G. Whitmore, Scott A. Meyer, Paul M. Arnold, Ashvin I. Patel, Robert D. Orr, Ajit A. Krishnaney, Peggy Boltes, Yoram Anekstein, Michael P. Steinmetz · 发表于：Journal of Neurosurgery Spine · 年份：2022 · DOI：10.3171/2022.7.spine22536 · 被引用次数：23 · 研究领域：Spine and Intervertebral Disc Pathology、Scoliosis diagnosis and treatment、Cervical and Thoracic Myelopathy

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success wa...