Enrolment has begun in the USA for a new patient study featuring two artificial cervical discs designed by spinal device manufacturer Centinel Spine, the prodisc C Vivo and prodisc C SK. The two discs will be compared to the Mobi-C cervical disc (Zimmer Biomet), a currently marketed total disc replacement (TDR) device.
The trial compares prodisc C SK and prodisc C Vivo with the approved, currently marketed TDR Mobi-C device as a control to compare safety and effectiveness to treat symptomatic cervical disc disease in subjects who have been unresponsive to non-operative, conservative treatment at two levels.
Patients experiencing pain in their neck and arms, between the ages of 18–69, with no prior surgeries in their cervical spine will be eligible for the randomised trial.
Overseen by principal investigator Todd H Lanman (Lanman Spinal Neurosurgery, Los Angeles, USA) patients enrolled in the two-to-one randomised trial will undergo a surgery in which they will receive either a prodisc C Vivo, prodisc C SK, or a Mobi-C. The two-to-one randomisation ensures for every two patients getting a prodisc C Vivo or prodisc C SK, one patient will receive a Mobi-C.
Disc replacement works by continuing to allow motion between the spinal levels, and with the prodisc devices, motion is provided by a ball and socket design, which allows for physiological range of motion while also ensuring stability to the spine.
The prodisc cervical discs are low profile, allowing for “stacking” of discs at adjacent spinal levels, otherwise known as multilevel application. The prodisc C Vivo design uses “teeth” fixation to hold the device in place, while the prodisc C SK incorporates low-profile “keels” for fixation. During the clinical trial, Lanman will choose the appropriate prodisc design to fit the patient’s anatomic needs.