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."
"These results underscore the effectiveness
of the TOPS™ System in providing superior clinical outcomes for
patients suffering from degenerative spondylolisthesis with
stenosis."
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,
PeterW@premiaspine.com, https://premiaspine.us
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SOURCE Premia Spine