Polyetheretherketone (PEEK)-on-ceramic total disc replacement (cTDR) is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion, according to new data.
The purpose of this prospective, non-randomised, historically controlled, multicentre US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial—the findings of which were published in the International Journal of Spine Surgery by Richard Guyer et al—was to compare the PEEK-on-ceramic Simplify Cervical Artificial Disc (NuVasive) with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration.
Guyer, an orthopaedic spine surgeon and co-founder of the Texas Back Institute in Plano, USA, said: “I am excited to see this study published on the Simplify Cervical Disc’s one-level FDA trial. Not only were the disc’s results excellent for the cTDR procedure compared to fusion, but it also breaks new ground in cervical technology by offering a combination of smaller, more anatomic disc heights, reproducing a spine’s natural motion, and being entirely MRI [magnetic resonance imaging] compatible unlike other cTDR implants.”
A total of 150 patients received the device while the historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial.
The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analogue scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI.
Results of the trial showed that the success rate was significantly greater in the TDR group compared with the ACDF group (93% vs 73.6%; p<0.001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points.
There were no significant differences in the rates of serious adverse event and the range of motion of the TDR level had increased significantly by three months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from pre-operation.
Kyle Malone, vice president of Clinical, Medical, and Regulatory Affairs at NuVasive, which acquired Simplify Medical in February this year, added: “This recent peer-reviewed publication validates the strong clinical data behind the Simplify Cervical Disc and why this is the most clinically effective technology in the cTDR procedure segment.
“As we continue to pursue Simplify Cervical Disc clinical data, we are encouraged by these results to support our commitment to outcome-driven innovation in spine surgery that benefits surgeons, hospitals, and—most importantly—patients.”