Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis

Author:

Nassr Ahmad1ORCID,Coric Domagoj2ORCID,Pinter Zachariah W.1ORCID,Sebastian Arjun S.1,Freedman Brett A.1ORCID,Whiting Donald3,Chahlavi Ali45,Pirris Stephen45ORCID,Phan Nicolas6ORCID,Meyer Scott A.7,Tahernia A. David8,Sandhu Faheem9,Deutsch Harel10ORCID,Potts Eric A.11,Cheng Joseph12ORCID,Chi John H.13,Groff Michael13ORCID,Anekstein Yoram1415ORCID,Steinmetz Michael P.16ORCID,Welch William C.17

Affiliation:

1. Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota

2. Carolinas Neurosurgery & Spine Associates, SpineFirst Atrium Health, Charlotte, North Carolina

3. Allegheny General Hospital, Pittsburgh, Pennsylvania

4. Ascension St. Vincent’s Spine & Brain Institute, Jacksonville, Florida

5. Mayo Clinic Florida, Jacksonville, Florida

6. Marshall University, Huntington, West Virginia

7. Atlantic Neurosurgical Specialists, Altair Health, Morristown, New Jersey

8. Desert Orthopedic Center, Rancho Mirage, California

9. MedStar Georgetown University Hospital, Washington DC

10. Rush University Medical Center, Chicago, Illinois

11. Goodman Campbell Brain and Spine, Indianapolis, Indiana

12. University of Cincinnati, Cincinnati, Ohio

13. Brigham and Women’s Hospital, Boston, Massachusetts

14. Shamir Medical Center, Zerifin, Israel

15. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv Israel

16. Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

17. Department of Neurological Surgery, Cleveland Clinic Foundation, Cleveland, Ohio

Abstract

Background: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. Methods: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. Results: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. Conclusions: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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