Oral Presentation 51st International Society for the Study of the Lumbar Spine Annual Meeting 2025

Lumbar Facet Arthroplasty for Spondylolisthesis and Stenosis: Two Year Outcomes from a Prospective Randomized Clinical Trial (115588)

Shelby Burks 1 , Joshua Marcus 2 , Michael Steinmetz 3 , William Welch 4 , Ahmed Nassr 5 , Evalina Burger 6 , Vincent Rossi 7 , James Lindley 8 , Domagoj Coric 7
  1. University of Miami Neurological Surgery, Miami, FL, United States
  2. Nuvance Health, Danbury, CT
  3. Cleveland Clinic, Cleveland
  4. University of Pennsylvania , Philadelphia
  5. Mayo Clinic, Rochester
  6. University of Colorado, Aurora
  7. Carolina Neurosurgery, Charlotte
  8. Neurologic Institute of Savannah, Savannah

Introduction: Until recently the surgical management for lumbar spondylolisthesis and stenosis ranged from decompression-only to fusion. Lumbar facet arthroplasty is a novel motion-preserving approach to treating spondylolisthesis with stenosis allowing for decompression of the neural elements, including removal of bilateral facets, and stabilization of the segment while preserving pre-operative motion at the treated level.

Methods: The study was a prospective, randomized, controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial evaluating lumbar facet arthroplasty (Investigational) to transforaminal interbody fusion (Control) and pedicle screw fixation, for the treatment of degenerative Grade I spondylolisthesis with stenosis. Follow-up duration was a minimum twenty-four months. The primary outcome was a composite measure of clinical success: (1) No reoperations (2) No device breakage (3) ODI reduction of > 15 points (4) No new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures.

Results: A total of 302 patients, randomized 2:1, were evaluated comparing the facet arthroplasty group (n=207) to the control TLIF group (n=95). The facet replacement group had higher overall clinical success at 24 months than did the TLIF group (76.6% vs. 49.3%; P=0.0001), equating to a between-group difference of 27.3% (95% CI 13.5% to 41.2%). The higher rate of clinical success in the facet replacement group was driven by subjects reporting no new or progressive neurologic deficit (91.2% vs 88.2%; P=0.0064) and a reduction in ODI of greater than 15 points (95.1% vs. 84.4%; P=0.0125).

Discussion: This study demonstrates that posterior lumbar decompression combined with motion-preserving facet arthroplasty is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Continued long-term follow-up, beyond 2 years, is required to validate these findings and evaluate differences between facet arthroplasty and fusion.