Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared with Circumferential Arthrodesis for the Treatment of Two-level Lumbar Degenerative Disc...

Background: Disc replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L total disc replacement as compared with spinal fusion for the treatment of degenerative disc disease at two contiguous vertebral levels from L3 to S1.

Methods: A total of 237 patients were treated in a randomized controlled trial designed as a non-inferiority study for regulatory application purposes. Blocked randomization was performed with use of a 2:1 ratio of total disc arthroplasty to circumferential arthrodesis. Evaluations, including patient self-assessments, physical and neurological examinations, and radiographic examinations, were performed preoperatively, six weeks postoperatively, and three, six, twelve, eighteen, and twenty-four months postoperatively.

Results: At twenty-four months, 58.8% (eighty-seven) of 148 patients in the total disc replacement group were classified as a statistical success, compared with 47.8% (thirty-two) of sixty-seven patients in the arthrodesis group; non-inferiority was demonstrated. The mean Oswestry Disability Index in both groups significantly improved from baseline (p < 0.0001); the mean percentage improvement for the total disc replacement group was significantly better than that for the arthrodesis group (p = 0.0282). An established clinical criterion for success, a ≥15-point improvement in the Oswestry Disability Index from baseline, occurred in 73.2% (109) of 149 patients in the total disc replacement group and 59.7% (thirty-seven) of sixty-two patients in the arthrodesis group. The Short Form-36 physical component scores were significantly better for the total disc replacement group as compared with the arthrodesis group (p = 0.0141 at twenty-four months). Visual analog scale scores for satisfaction significantly favored total disc replacement from three to twenty-four months. At twenty-four months, 78.2% (111) of 142 patients in the total disc replacement group and 62.1% (thirty-six) of fifty-eight patients in the arthrodesis group responded "yes" when asked if they would have the same surgery again. Lumbar spine range of motion on radiographs averaged 7.8° at the superior disc and 6.2° at the inferior disc in patients with total disc replacement. Reduction in narcotics usage significantly favored the total disc replacement group at twenty-four months after surgery (p = 0.0020).

Conclusions: Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes.