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

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  • 1 Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina;
  • | 2 Department of Neurosurgery, SpineFirst, Atrium Health, Charlotte, North Carolina;
  • | 3 Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota;
  • | 4 Department of Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania;
  • | 5 Wisconsin Bone and Joint, Milwaukee, Wisconsin;
  • | 6 Orthopedic Institute of Pennsylvania, Harrisburg, Pennsylvania;
  • | 7 Department of Neurosurgery, Allegheny Health Network, Pittsburgh, Pennsylvania;
  • | 8 Department of Neurosurgery, Ascension St. Vincent, Jacksonville, Florida;
  • | 9 Department of Neurosurgery, Brigham & Women’s Hospital, Boston, Massachusetts;
  • | 10 Department of Neurosurgery, Baylor Scott & White Medical Center, Temple, Texas;
  • | 11 Axis Spine Center, Coeur d’Alene, Idaho;
  • | 12 Department of Neurosurgery, Lahey Medical Center, Burlington, Massachusetts;
  • | 13 Department of Neurosurgery, Altair Health Spine, Morristown, New Jersey;
  • | 14 Carle Neuroscience Institute, Urbana, Illinois;
  • | 15 Kennedy-White Orthopaedic Center, Sarasota, Florida;
  • | 16 Department of Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio; and
  • | 17 Department of Orthopaedics, Sackler School of Medical of Medicine, Tel Aviv, Israel
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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 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°).

CONCLUSIONS

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.

ABBREVIATIONS

AE = adverse event; CCS = composite clinical success; IDE = investigational device exemption; ITT = intention to treat; ODI = Oswestry Disability Index; ROM = range of motion; TDR = total disc replacement; TLIF = transforaminal lumbar interbody fusion; TOPS = Total Posterior Spine; VAS = visual analog scale; ZCQ = Zurich Claudication Questionnaire.

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JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

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