Artificial disc demonstrates good 2- to 3-year results in IDE trial
The ProDisc-C alleviated pain and improved function comparably to discectomy and fusion.
BRUSSELS At 2- to 3-year follow-up, a new total disc replacement produced outcomes comparable to those achieved by anterior cervical discectomy and fusion performed at a single level, according to data from a U.S. clinical trial presented here.
The study included 50 patients treated at one of five centers in the United States as part of an investigational device exemption (IDE) trial. Investigators compared outcomes for 28 patients treated with anterior cervical discectomy and fusion to those for 22 patients who received the ProDisc-C artificial cervical disc [Synthes].
Patients were assessed preoperatively and at 6 weeks and 3, 6, 12, 18 and 24 months postoperatively.
The researchers recorded and stratified complications based whether they were device-related or approach-related, or whether they occurred postoperatively, according to Jeffrey Goldstein, MD, of the Hospital for Joint Diseases Spine Center at New York University. He presented findings from the multicenter study at the 9th Annual Meeting of the Spine Society of Europe.
The average patient age 42 years and body mass index for the two groups were similar at the time of surgery. Also, both groups had similar operative times and rates of blood loss, he said.
Over 60% of patients underwent surgery at the C5-C6 level, he noted.
Neck Disability Index scores showed statistically significant improvements (P<.001) at all follow-up points. However, "We saw no significant differences between the groups," Goldstein said.
Neck and arm pain scores had also improved at all follow-up points and were comparable between the groups.
Visual Analog Scale satisfaction scores at 2 years demonstrated that over 90% of patients in both groups were satisfied with their outcomes.
Postoperative radiographs showed restored disc height and maintained range of motion in both groups, according to the study abstract.
"We feel that the ProDisc-C improved function and relieved patients' pain similar to that of [anterior cervical discectomy and fusion]," Goldstein said.
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- Orthopedics Today was unable to determine whether Jeffrey Goldstein, MD, has a financial conflict of interest related to any product or company cited in this article.
- Goldstein J, Chapman J, Yue J, et al. Cervical disc arthroplasty with ProDisc-C: Clinical IDE trial results from 5 centers with 2- to 3-year follow-up. #11. Presented at the 9th Annual Meeting of the Spine Society of Europe. Oct. 2-6, 2007. Brussels.