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Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis
Journal article   Open access   Peer reviewed

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

Domagoj Coric, Ahmad Nassr, Paul K Kim, William C Welch, Stephen Robbins, Steven DeLuca, Donald Whiting, Ali Chahlavi, Stephen M Pirris, Michael W Groff, …
Journal of neurosurgery. Spine, v 38(1), 115
01 Jan 2023
DOI: https://doi.org/10.3171/2022.7.SPINE22536
PMID: 36152329
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.3171/2022.7.SPINE22536View
Published, Version of Record (VoR)CC BY V4.0,  Open

Abstract

Arthroplasty Back Pain - surgery Constriction, Pathologic - surgery Humans Lumbar Vertebrae - diagnostic imaging Lumbar Vertebrae - surgery Minimally Invasive Surgical Procedures Pedicle Screws Prospective Studies Retrospective Studies Spinal Fusion - methods Spondylolisthesis - diagnostic imaging Spondylolisthesis - surgery Treatment Outcome
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. 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. 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 was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

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11 Record Views
20 citations in Web of Science
12 citations in Scopus

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Collaboration types
Domestic collaboration
International collaboration
Web of Science research areas
Clinical Neurology
Surgery
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