GENEVA — Patients with symptomatic lumbar degenerative disease demonstrated comparable outcomes from either a single-level or double-level lumbar disc replacement, according to a report presented here.
Researchers involved in a multicenter Investigational Device Exemption trial on the use of the ProDisc-L lumbar disc replacement (Synthes Spine) also reported that patients who received the total disc replacement (TDR) at either one or two levels demonstrated a similar degree of overall improvement compared to control group patients who had a fusion.
Two-hundred thirty-seven patients who underwent the two-level procedure were compared to 236 patients who had a one-level disc replacement at 17 sites throughout the United States, said Jeffrey Goldstein, MD, of New York University's Hospital for Joint Diseases, who presented the findings at Spine Week 2008, here. The researchers also compared the results to those of 80 control group patients who received posterolateral fusion with iliac crest bone graft and/or allograft and fixation.
The researchers evaluated patients preoperatively and postoperatively at 6 weeks and at 3, 6, 12, 18 and 24 months.
At 2 years, "We saw that 90% of the patients who received the two-level procedure and 91.8% of one-level patients reported improvement in their Oswestry Disability Index (ODI) score," he said. Likewise, 73.3% of two-level TDR patients and 77.2% of one-level TDR patients met the 15-point ODI improvement goal, compared to 55.9% of patients who received a two-level fusion and 64.8% of patients who received a one-level fusion, Goldstein added.
Patients who received the two-level TDR recorded SF-36 scores that were significantly higher than those of two-level fusion patients at each follow-up point.
Also, patients who received the ProDisc-L showed significantly higher pain reduction than control patients at 24 months (P = .0466), according to the abstract.
"This is the first time we have presented two-level data for the ProDisc-L, and we found that it is safe and effective for patients who have one- or two-level degenerative disease between L3 and S1," Goldstein said.
For more information:
- Goldstein J, Delamarter RB, Zigler J, et al. Two-level ProDisc-L investigational device exemption (IDE) clinical trial results vs. one-level ProDisc-L IDE clinical trial results. Paper C7. Presented at Spine Week 2008. Geneva, Switzerland.