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Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease

Zigler, Jack, MD*; Delamarter, Rick, MD; Spivak, Jeffrey M., MD§§§; Linovitz, Raymond J., MD, FACS§; Danielson, Guy O. III, MD; Haider, Thomas T., MD; Cammisa, Frank, MD#; Zuchermann, Jim, MD**; Balderston, Richard, MD††; Kitchel, Scott, MD‡‡; Foley, Kevin, MD§§; Watkins, Robert, MD∥∥; Bradford, David, MD¶¶; Yue, James, MD##; Yuan, Hansen, MD***; Herkowitz, Harry, MD†††; Geiger, Doug, MD‡‡‡; Bendo, John, MD§§§; Peppers, Timothy, MD§; Sachs, Barton, MD*; Girardi, Federico, MD#; Kropf, Michael, MD; Goldstein, Jeff, MD§§§

doi: 10.1097/BRS.0b013e318054e377
Randomized Trial

Study Design. A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.

Objective. 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.

Methods. 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.

Results. 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°.

Conclusions. 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: jzigler@texasback.com

© 2007 Lippincott Williams & Wilkins, Inc.