Orthopaedic medical device developer Synergy Spine Solutions has commenced the 2-Level clinical trial of its Synergy Disc artificial cervical disc with the enrolment of the first patient.
Synergy Disc has been designed for restoring both motion and alignment to the spine.
The trial, which is carried out under a US investigational device exemption, will assess the safety and effectiveness of Synergy Disc.
As part of the trial, the artificial cervical disc will be compared to anterior cervical discectomy and fusion to treat degenerative disc disease in patients who are symptomatic at two contiguous vertebral levels from C3 to C7.
The company will recruit 200 patients at up to 25 sites for the non-randomised, prospective, multi-centre and historically controlled trial.
Patients will be assessed preoperatively during and immediately after surgery at six weeks and then at three, six, 12 and 24 months following surgery.
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Annual follow-up will continue until the final subject completes follow-up for 24 months.
Synergy Spine Solutions CEO Josh Butters said: “Beginning our 2-Level trial on the heels of completing enrolment in the 1-Level trial is another significant advance in our US market access pathway and puts us further down the path towards realising our mission of expanding the surgeons and patients that have access to the Synergy Disc technology.
“I am eager to evaluate the results of our 2-Level trial, as the design of the Synergy Disc was specifically created to address the complexities associated with alignment, stability and balance in multi-level artificial disc replacement.”