TOPS facet joint replacement demonstrates significant improvements versus fusion in IDE trial

Premia Spine’s TOPS system

Premia Spine has announced the publication of two-year outcomes from the TOPS facet joint replacement system’s clinical trial in the Journal of Neurosurgery Spine, which found that found lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement versus lumbar fusion in all patient-reported outcome measures, a low surgical complication rate, and the ability to maintain motion at the index level while limiting sagittal translation.

The objective of the prospective, randomised, multicentre US Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial is to compare the two-year clinical and radiographic outcomes and safety profile of patients undergoing either a lumbar TOPS facet arthroplasty or a transforaminal lumbar interbody fusion (TLIF).

This publication is the first interim comparative analysis of early clinical outcomes and complications from the TOPS IDE trial.

Dom Coric (Carolina Neurosurgery and Spine Associates, Charlotte, USA) principal investigator in the TOPS IDE study and lead author of the publication, said: “The two-year data from this study indicate the TOPS system compares favourably in all respects to outcomes reported in the FDA trial to a single-level TLIF.

“If at the conclusion of the ongoing clinical trial we see continued favourable outcomes, we will be able to conclude that motion preservation with TOPS facet arthroplasty is a viable alternative to fusion in select patients with spinal stenosis and spondylolisthesis for restoring segmental stability while maintaining motion at the affected segment.”

A total of 249 patients were evaluated, with 170 patients in the TOPS investigational arm of the clinical trial and 79 in the TLIF group. TOPS demonstrated a statistically significant advantage over fusion in achieving a meaningful improvement in daily function as measured by Oswestry Disability Index (93% vs. 81% of patients). The facet replacement group also had a lower reoperation rate than the TLIF group (5.9% vs. 8.8%). The TOPS patients maintained complete segmental motion at two years versus their pre-operative measurements.

Lumbar facet arthroplasty with the TOPS device demonstrated a low complication rate, significant improvement in all PROMs, and the ability to maintain motion at the index level while limiting sagittal translation. Additional findings suggest that the TOPS device maintains motion at the index surgical level while preventing further sagittal translation, a recent press release states.

Ron Sacher, CEO of Premia Spine, added: “We are encouraged by the data presented in this publication, which show promising results for TOPS when compared to TLIF. We are demonstrating that the TOPS device dramatically improves patients’ quality of life without sacrificing motion at a previously pathologic intervertebral segment. These data further indicate that we are getting closer to our goal of providing a viable alternative to fusion for those suffering from lumbar spinal stenosis and degenerative spondylolisthesis.”


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