A new study published in the Journal of Neurosurgery: Spine examines outcomes for the Prestige cervical disc compared with anterior cervical discectomy and fusion.
The researchers examined prospectively collected data from patients who underwent cervical disc replacement using the Prestige disc at 20 sites and compared the data to 265 historical control ACDF patients in the initial investigational device exemption study.
Both groups were similar demographics. The researchers found:
1. There wasn't a significant difference in blood loss, with 51 ml for the Prestige disc and 57.1 ml for the fusion group.
2. The hospital length of stay was similar between both groups.
3. The patients undergoing disc replacement had a longer operative time — 1.49 hours — compared with 1.38 hours for the fusion group.
4. There was significant improvements reported in the NDI, neck/arm pain, SF-36 and neurological status for the patients 1.5 months after surgery in both groups. The patients also sustained these results at 24 months.
5. One and two years after surgery, the average NDI score improved 30 points for both groups. The SF-36 PCS scores improved by 14.3 points in the investigational group and 11.9 points in the control group two years after surgery. The neurological success after two years was 93.5 percent in the artificial disc group and 83.5 percent in the fusion group.
6. There was 12.1 percent of the disc replacement group and 15.5 percent of the fusion group reporting AE classified as device or device/surgical procedure-related issues at 24 months. There were 14 disc replacement patients who underwent a second surgery — 5 percent — and 21 fusion patients who underwent a second surgery — 7.9 percent.
7. The average return-to-work time for the disc replacement group was 40 days after surgery, compared with 60 days in the fusion group.
8. The average angular range of motion for the disc replacement group was 7.9 degrees at 12 months and 7.5 degrees at 20 months.
9. Two years after surgery, 90 percent of the disc replacement patients and 87.7 percent of the fusion patients reported satisfaction with their surgical results.
10. The researchers concluded the Prestige disc superiority on overall success without disc height success.