Synergy Spine Solutions Ltd, a orthopaedic medical device developer focused on artificial cervical disc replacement, recently announced it has enrolled the first patient in its US IDE 2-Level clinical trial.
Conducted under a US Investigational Device Exemption (IDE), the 2-Level trial will evaluate the safety and effectiveness of the Synergy Disc® artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease in subjects that are symptomatic at two contiguous vertebral levels from C3 to C7.
The Synergy Disc trial is a multi-center, prospective, non-randomized, historically controlled study that will be conducted on 200 patients at up to 25 sites. All patients in the study will receive the Synergy Disc. Patients will be evaluated preoperatively, at the time of surgery, immediately following surgery, at six weeks and three, six, 12 and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up.
Dr. David Musante, a neurosurgeon in Raleigh-Durham, North Carolina, has the distinction of being the first site activated for the Synergy 2-Level trial. Dr. Musante said: “Initiation of the 2-Level clinical trial is an important and essential milestone for the Synergy Cervical Disc. In the real-world setting, I am performing two-level procedures as frequently, if not more frequently than one-level procedures.
“Having had the opportunity to participate in the single-level trial, I am looking forward to beginning this natural next step. In a two-level replacement, there is potentially more opportunity to see the benefits of restoring lordosis and maintaining physiologic motion. My hope is th