A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study — The International Society for the Study of the Lumbar Spine
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  3. A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study (#15)

Zachariah W Pinter 1 , Harold Salmons 1 , Brett A Freedman 1 , Ahmad N Nassr 1 , Arjun S Sebastian 1 , Domagoj Coric 2 , William C Welch 3 , Michael P Steinmetz 4 , Stephen E Robbins 5 , Yossi Smorgick 6 , Yoram Anekstein 6
  1. Mayo Clinic, Rochester, MINNESOTA, United States
  2. Carolinas Neurosurgery & Spine Associates, Charlotte, North Carolina
  3. University of Pennsylvania, Philadelphia, Pennsylvania
  4. Cleveland Clinic Foundation, Cleveland, Ohio
  5. Wisconsin Bone & Joint, Milwaukee, Wisconsin
  6. Shamir Medical Center, Zerifin, Israel

Introduction

Lumbar facet arthroplasty is a method of dynamic stabilization used to treat Grade 1 spondylolisthesis with stenosis. There are currently no FDA-approved devices for facet arthroplasty. The purpose of the present study is to report the 1-year clinical and radiographic outcomes as well as safety profile of patients who underwent lumbar facet arthroplasty via implantation of the TOPS device as part of a prospective Investigational Device Exemption (IDE) trial.

 

Methods

We reviewed the prospectively collected clinical and radiographic outcomes of patients who underwent facet arthroplasty via implantation of the TOPS device in the investigational arm of a multicenter, prospective, randomized, controlled Food and Drug Administration (FDA) IDE trial. Standard demographic information was collected for each patient, including surgical variables. Radiographic parameters and patient reported outcome measures (PROMs) including ODI, VAS back and leg, and ZCQ were assessed preoperatively and at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Adverse event, complication, and reoperation data were also collected for each patient.

 

Results

At the time of this study, 153 patients had undergone implantation of the TOPS device as part of this ongoing clinical trial and were included in this study. The mean surgical time was 187.8 minutes and mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean ODI, VAS leg and back, and ZCQ scores improved significantly at all postoperative time points (P>0.001). Greater than 79% of patients achieved MCID in all patient reported outcome measures at all postoperative time points. There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up without evidence of worsening sagittal translation. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device, including two new neurological deficits, two dural tears, two retained drains, one misplaced pedicle screw, one screw loosening, one infection, one seroma, and one hematoma.  Nine patients (5.9%) underwent a total of 13 reoperations, eight for surgical complications (5.3%) and one (0.6%) of which was for device-related failure due to bilateral L4 pedicle screw loosening.

 

Discussion

Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all PROMs and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate. The complication rates and improved postoperative PROMs are similar to those reported in the literature following single-level TLIF.

 

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