PEEK-on-ceramic implant for cervical disc replacement decreased pain, increased function
Preliminary results from an FDA investigational device exemption study showed a clinically significant decrease in pain and increase in function with the use of a PEEK-on-ceramic device in two-level cervical total disc replacement.
“Statistically significant increases in disc space height and range of motion with this early data suggest both safety and efficacy for simplified PEEK-on-ceramic total disc replacement for two-level pathology,” Domagoj Coric, MD, said in his presentation at the North American Spine Society Annual Meeting, which was held as a virtual event.
Coric and colleagues collected patient-reported outcome measures, including standard neck disability index (NDI), numerical rating score (NRS) for neck pain, and right and left arm intensity scores, among 62 patients undergoing two-level cervical total disc replacement with a PEEK-on-ceramic implant (Simplify Disc, Simplify Medical).
“There were also radiographic measures which included baseline measures of disc height, and the range of motion evaluations were conducted at preoperative baseline followed by 6 week, 3 months, 6 months and 12 months after surgery,” Coric said. “All radiographs were analyzed by an independent lab.”
Coric noted a significant decrease in the mean NDI score from 55.6 preoperatively to 12.7 at 12-month follow-up, as well as a significant decrease in neck pain scores. Results showed mean right and left arm pain scores decreased significantly from vales of more than 5 preoperatively to values of less than 1.5 at all follow-up visits.
“The radiographic results mimic the clinical results in that they were positive as far as showing mean disc heights at both implanted levels increased significantly at all follow-up points compared to preoperative values,” Coric said.
Range of motion at the inferior level implanted had a significant increase from 6° to 8.7°, according to Coric.
“At the superior implanted level, there was an increase in range of motion, but it was nonsignificant, from 8.5 preoperatively to 9.4 at 12 months,” Coric said.
Collapse
Guyer R, et al. Abstract #162. Presented at: North American Spine Society Annual Meeting; Oct. 6-9, 2020 (virtual meeting).
Read more about