Synergy Spine Solutions has enrolled the last patient in its investigational device exemption (IDE) clinical trial. The 1-Level Synergy Disc trial (NCT04469231) is set out to evaluate the efficacy of the Synergy Disc device compared to anterior cervical discectomy and fusion in patients – the standard treatment for patients with degenerative disc disease (DDD).
Patients enrolled were symptomatic at only one level from the third cervical vertebra to the seventh and unresponsive to conservative management. Neck disability index, neurological assessment, secondary surgical interventions, and device-related adverse events all measured two years after surgery constitute primary endpoints. The multicentre, prospective, non-randomised, historically controlled study also has collaboration from the MCRA. The orthopaedic medtech company says it is planning a pre-market approval application to the US Food and Drug Administration (FDA) based on the trial’s data.
The Synergy Disc is made from a titanium endplate with a polyethylene core. The mobile centre of rotation helps restore motion and correct sagittal balance. According to the Colorado, US-based company, it is the only device designed to restore both motion and alignment to the spine.
DDD is considered a normal part of ageing, but its effects on motion can severely affect daily activities. Artificial discs are becoming a gold standard treatment for the condition, whilst other technologies are emerging that use protein release from a tissue scaffold that drives bone formation.
“I just enrolled one of the last trial patients in the study and, after having performed thousands of cervical artificial disc replacements, the Synergy Disc has provided unique performance enhancements,” said Dr Todd Lanman, a spinal neurosurgeon, and principal investigator for the trial.
“Particularly, the Synergy Disc provides correction of the curve of the spine because the implant has a six-degree lordotic correction which has been quite beneficial for realigning the curve of the neck to its proper position.”