Study Results: Premia Spine TOPS Arthroplasty System

By Julie A. Vetalice

Study Results: Premia Spine TOPS Arthroplasty System

Intermediate clinical study results support the use of Premia Spine's TOPS™ facet arthroplasty system for lumbar spinal stenosis and degenerative spondylolisthesis. The data showed that patients treated with TOPS had consistently good outcomes at the six-week immediate post-operative visit that were maintained and even improved at 12 months.

The interim analysis reviewed 153 TOPS patients, 58 of which had reached 12-month follow-up. The patient-reported outcomes demonstrate significant early and sustained improvements in the Oswestry Disability Index, visual analog scale-Back, and VAS-Leg scores:

  • Mean baseline ODI, VAS-Back, and VAS-Leg were 57.1, 69.0, and 85.6 respectively
  • ODI improved 36.8 points at six weeks and 46.2-points at 12 months
  • VAS-Back improved 54.9 points at six weeks and 58.4 points at 12 months
  • VAS-Leg improved 73.5 at six weeks and 72.3 points at 12 months

Reported to be the first and only facet joint replacement system for the lumbar spine, TOPS was developed to provide mobility, stability and durability after decompression for patients with lumbar spinal stenosis and degenerative spondylolisthesis.

Source: Premia Spine

Product Labels: Lumbar Spine

Tags: Trial/Study