A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial
To evaluate the safety and effectiveness of the ProDisc®-L
(Synthes Spine, West Chester, PA) lumbar total disc replacement
compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1.
Summary of Background Data.
As part of the Investigational Device Exemption clinical trial
, favorable single center results of lumbar total disc replacement
with the ProDisc®-L
have been reported previously.
Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation.
Safety of ProDisc®-L
implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the ≥15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P
= 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc®-L
patients recorded SF-36 Health Survey scores significantly higher than the control group (P
= 0.018, P
= 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P
< 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P
= 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7°.
has been found to be safe and efficacious. In properly chosen patients, ProDisc®-L
has been shown to be superior to circumferential fusion
by multiple clinical criteria.