According to one-year findings from the clinical FDA IDE trial, lumbar facet arthroplasty with the TOPS system sustains motion at the index surgical level
TOPS is intended to provide mobility, stability, and durability after decompression for patients having lumbar spinal stenosis and degenerative spondylolisthesis. (Credit: Business Wire/Premia Spine)
Medical technology company Premia Spine has published the one-year outcomes from the clinical trial of TOPS facet replacement system which demonstrated significant improvement in all patient-reported outcome measures (PROMs).
The study, whose findings were recently published in the Clinical Spine Surgery journal, compared the two-year clinical and radiographic outcomes and safety profile of patients subjected to a lumbar TOPS facet arthroplasty or a transforaminal lumbar interbody fusion (TLIF).
The trial showed that lumbar facet arthroplasty with the TOPS facet replacement system had a low surgical complication rate and the ability to sustain motion at the index level while restricting sagittal translation.
Following single-level TLIF, the complication rates and improved postoperative PROMs were comparable to those reported in the literature. Because of adjacent segment degeneration, no patient in the TOPS group needed a second surgery within the first year, Premia Spine said.
Premia Spine CEO Ron Sacher said: “We are encouraged by the data presented in this publication, which show promising results for TOPS when compared to TLIF.
“Unlike standard fusion constructs, the purpose of the TOPS device is to maintain motion at a previously pathologic intervertebral segment.
“These data indicate we are getting closer to our goal of providing a viable alternative to fusion for those suffering from lumbar spinal stenosis and degenerative spondylolisthesis.”
The randomised, multi-centre US Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial featured 153 patients in the investigational arm who underwent implantation of the TOPS device.
The PROMs and radiographic analyses included 105 of the 153 individuals who had reached their one-year follow-up at the time of the interim assessment, the medical technology company added.
The firm said that the clinical study of the TOPS facet replacement system will enable surgeons to provide patients with more precise advice regarding the optimal course of treatment for lumbar spinal stenosis and degenerative spondylolisthesis.