Intermediate clinical study results, which were presented at the Society for Minimally Invasive Spine Surgery (SMISS) annual meeting (28–30 October, Las Vegas, USA) by John Chi (Boston, USA), support the use of Premier Spine’s Tops system for lumbar spinal stenosis and degenerative spondylolisthesis.
The data show that patients treated with Tops had consistently good outcomes at the six-week immediate post-operative visit and that these results were maintained and even improved upon 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 (ODI), visual analogue scale (VAS)-Back, and VAS-Leg scores.
Mean baseline ODI, VAS-Back, and VAS-Leg were 57.1, 69, and 85.6 respectively. In addition, 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.
Commenting on the data, Chi said: “These results point to the potential of Tops becoming a new and exciting option for the treatment of degenerative spondylolisthesis that allows us to stabilise patients while preserving motion. While the study remains underway, I am very encouraged by the interim patient-reported data.”
The first and only facet joint replacement system for the lumbar spine, Premia Spine’’s Tops system was designed to provide mobility, stability and durability after decompression for patients with lumbar spinal stenosis and degenerative spondylolisthesis. The system is an articulating single-level prosthesis affixed to the spine by pedicle screws. Unlike fusion, it allows the spine to maintain mobility, flexibility and range of motion by providing physiologic multiaxial, three-column stabilisation, say Premia Spine.
“These interim results add to a large foundation of data we have gathered and are continuing to gather to build clinical evidence for Tops,” added Premia Spine CEO Ron Sacher. “We are committed to offering a new solution to patients seeking an alternative to fusion for the treatment of spinal stenosis and degenerative spondylolisthesis that allows patients to retain the natural motion of their spine.”