Spine technology company NuVasive has reported positive findings from a clinical study that evaluated its Cohere Porous polyetheretherketone (PEEK) implant in patients with degenerative cervical disc disease.
Data showed improved early outcomes in anterior cervical discectomy and fusion (ACDF) procedures with the Cohere implant, compared to structural allograft and smooth PEEK.
Cohere features a three-dimensional (3D) porous design to stimulate and promote bone in-growth and stabilisation without affecting implant strength or radiolucency.
The implant is based on the company’s Porous PEEK Technology, which involves manufacturing via an extrusion process to ensure unified porous-to-solid structure.
According to NuVasive, Porous PEEK implants mitigate stress shielding and subsidence risk, compared to standard metal implants.
Out of the total 167 patients, those treated with NuVasive’s device experienced significant clinical improvements, better outcomes within six weeks and sustained improvements through 12-months post-op.
The trial results showed clear improvements in neck disability index (NDI) scores and pain by six-weeks post-op with Cohere, while significant improvements were observed three-months post-op with smooth PEEK.
In addition, the Porous PEEK led to statistically significant improvements from baseline by two weeks and the structural allograft patients showed improvements by six weeks.
The improvements in Porous PEEK patients were found to be significantly greater than allograft and smooth PEEK by six-weeks post-op. These improvements were retained at all post-op time points through to one year.
The results have been published in the Journal of Spine & Neurosurgery.
NuVasive Medical Affairs senior director Kyle Malone said: “This is the first comparative study between NuVasive’s Cohere Porous PEEK, smooth PEEK and allograft interbody spacers in ACDF, and it was found that patients treated with a Porous PEEK implant experienced incrementally improved early clinical improvements, which were sustained through the course of the study.”