Premia Spine's latest published study proves that lumbar facet arthroplasty significantly outperforms traditional spinal fusion in treating patients with Grade I degenerative spondylolisthesis and stenosis, showcasing superior clinical success and improved patient outcomes.
NORWALK, Conn., June 26, 2024 /PRNewswire-PRWeb/ -- The prestigious Journal of Bone and Joint Surgery released the results of the TOPS™ System pivotal study titled "Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial."
This groundbreaking study, authored by Dr. Ahmad Nassr from the Mayo Clinic and colleagues, compares the effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus lumbar spinal fusion in patients with lumbar spinal stenosis (LSS) and Grade I degenerative spondylolisthesis (DS). Conducted under an FDA Investigational Device Exemption (IDE), this trial represents a significant advancement in spinal treatment options.
Key Findings:
- Superior Clinical Success: The study demonstrated that 73.5% of patients in the arthroplasty group achieved composite clinical success at 24 months postoperatively compared to just 25.5% in the fusion group (p < 0.001). This reflects a substantial between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%).
- Patient-Reported Outcomes: The arthroplasty group outperformed the fusion group in most patient-reported outcome measures, including the Oswestry Disability Index (ODI), visual analog scale (VAS) for back pain, and Zurich Claudication Questionnaire (ZCQ) scores, all at 24 months postoperatively.
- Reduced Complications: The fusion group exhibited a higher rate of symptomatic adjacent segment degeneration and had a higher revision rate. Surgical variables and overall complications were similar between the groups.
"These results underscore the effectiveness of the TOPS™ System in providing superior clinical outcomes for patients suffering from degenerative spondylolisthesis with stenosis," stated Ron Sacher, CEO of Premia Spine. "This study reaffirms our commitment to innovation and improving patient quality of life through advanced spinal solutions."
Study Design and Oversight:
This randomized controlled trial included 321 patients who were assigned in a 2:1 ratio to undergo either decompression plus lumbar facet arthroplasty or decompression plus lumbar fusion. The primary outcome was the overall rate of composite clinical success at 24 months postoperatively. Secondary outcomes included ODI scores, VAS for back and leg pain, ZCQ scores, Short Form (SF)-12 scores, radiographic parameters, surgical variables, and complications.
Patients eligible for inclusion had LSS and DS, were between 35 and 80 years of age, and had undergone more than six months of unsuccessful nonsurgical therapy. The trial was conducted at 37 medical centers with institutional review board approval and patient consent.
Peter Wehrly, President of Premia Spine, added, "This study marks a significant milestone in spinal treatment. The TOPS™ System offers a viable alternative to traditional fusion, preserving natural spinal motion and reducing the risk of adjacent segment degeneration."
Background:
Lumbar spinal stenosis with degenerative spondylolisthesis is the most common indication for lumbar fusion surgery among patients over the age of 50 years in the United States. There has been ongoing controversy regarding the relative efficacy of decompression alone versus decompression plus fusion, with conflicting results across several Level-I studies. High reoperation rates, lackluster patient-reported outcome measures (PROMs), and high healthcare costs have drawn attention to a lack of a good solution for this large patient population.
Decompression plus lumbar facet arthroplasty is now emerging as an alternative treatment, allowing thorough decompression of neural elements, stabilization of spondylolisthesis, and preservation of motion. The TOPS™ System (Total Posterior Spine System) has proven that there is a better alternative to treat LSS and DS through the replacement of the facet joint.
About Premia Spine
Premia Spine, a medical technology company, is committed to enhancing the quality of life for patients suffering from chronic leg and back pain. Its products are specifically designed to offer durability, stability, and increased mobility to those struggling with lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions. Visit https://premiaspine.us/ to learn more.
Media Contact
Peter Wehrly, Premia Spine, 1 (303) 324-4983, [email protected], https://premiaspine.us
SOURCE Premia Spine
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