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.
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°.
ProDisc®-L 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.
A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial was conducted comparing ProDisc®-L total disc replacement (Synthes Spine, West Chester, PA) to circumferential fusion. Two hundred eighty-six patients were treated and followed to 24 months. ProDisc®-L was shown to be safe and efficacious, and superior to circumferential fusion by multiple clinical criteria.
From the *Texas Back Institute/Texas Health Research Institute, Plano, TX; †The Spine Institute at Saint John's Health Center, Santa Monica, CA; ‡Hospital for Joint Diseases, New York, NY; §CORE Orthopaedic Medical Center, Encinitas, CA; ∥Texas Spine and Joint Hospital, Tyler, TX; ¶Haider Spine Center Medical Clinic, Inc., Riverside, CA; #Hospital for Special Surgery, New York, NY; **St. Mary's Spine Center, San Francisco, CA; †† Pennsylvania Hospital, Philadelphia, PA; ‡‡Orthopedic Spine Associates, LLC, Eugene, OR; §§Semmes-Murphey Neurological & Spine Institute, Methodist University Hospital, University of Tennessee, Memphis, TN; ∥∥LA Spine Surgery Institute, Los Angeles, CA; ¶¶University of California at San Francisco, San Francisco, CA; ##Yale University, New Haven, CT; ***SUNY Syracuse, Syracuse, NY; †††William Beaumont Hospital, Royal Oak, MI; ‡‡‡Michigan Brain & Spine Institute PC, MI Orthopaedic Center, Ypsilanti, MI; and §§§New York University Medical Center/Hospital for Joint Diseases Spine Center, New York, NY.
Acknowledgment date: August 7, 2006. First revision date: September 22, 2006. Acceptance date: October 23, 2006.
The device(s)/drug(s) that is/are the subject of this manuscript is/are being evaluated as part of an ongoing FDA-approved investigational protocol (IDE) or corresponding national protocol.
No funds were received in support of this work. One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies.
Address correspondence and reprint requests to Jack Zigler, MD, Texas Back Institute/Texas Health Research Institute, Suite 200, 6020 W. Parker Road, Plano, TX 75093; E-mail: email@example.com