Early postoperative pain and function scores reported for patients treated with a lumbar total disc replacement device held up well at 5-year follow-up evaluations, according to investigators.
Jeffrey A. Goldstein, MD, presented data from a prospective, randomized U.S. Food and Drug Administration investigational device exemption trial comparing the safety profile and efficacy of the ProDisc-L (Synthes Spine) to that of circumferential 360° fusion for treating degenerative disc disease (DDD) at L3-S1 in 292 patients.
Goldstein said the clinical success of one-level disc replacement with the ProDisc-L vs. lumbar interbody fusion was evident from patient satisfaction outcomes, in which 83% of ProDisc-L patients said they would have the surgery again and 50% of the fusion patients
said that they would have this surgery again when you looked at the 5-year follow-up.
He presented the study findings at Spine Week 2008.
The study included 162 patients randomized to receive the total disc replacement (TDR) device, 50 nonrandomized patients from the surgeons early experience with the device and 80 patients who received lumbar fusion. They were aged 18 to 60 years with one-level DDD.
Goldstein said Oswestry Disability Index (ODI) scores improved more in the TDR group than the control group. Preoperatively both groups ODI scores indicated a high degree of disability.
At 24 months, Both groups showed statistically significant improvements from the baseline. Interestingly, these results held up after 36 months, 48 months and at the 5-year follow-up, he said.
Investigators also observed a positive trend for pain resolution in these cases, with Visual Analog Scale pain scores improving significantly by the 2-year follow-up.
For more information:
- Jeffrey A. Goldstein, MD, can be reached at NYU Hospital for Joint Diseases, 19 Beekman St., 6th Floor, New York, NY 10038; 212-513-7711; e-mail: firstname.lastname@example.org. He has indicated he receives research and travel support from and is a consultant
to Synthes Spine.
- Delamarter RB, Zigler J, Goldstein J. 5-year results of the prospective, randomized, multicenter FDA investigational device exemption (IDE) ProDisc-L total disc replacement (TDR) clinical trial. Paper #C3. Presented at Spine Week 2008. May 26-31, 2008. Geneva.