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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 DiseaseResults at Twenty-four Months
Rick Delamarter, MD1; Jack E. Zigler, MD2; Richard A. Balderston, MD3; Frank P. Cammisa, MD4; Jeffrey A. Goldstein, MD5; Jeffrey M. Spivak, MD5
1 The Spine Institute at Saint John's Health Center, 1301 20th Street, Suite 400, Santa Monica, CA 90404
2 Texas Back Institute/Texas Health Research Institute, 6020 West Parker Road, Suite 200, Plano, TX 75093
3 Pennsylvania Hospital, 800 Spruce Street, 1st Floor, 3B, Philadelphia, PA 19107
4 Hospital for Special Surgery, 523 East 72nd Street, New York, NY 10021
5 Hospital for Joint Diseases Spine Center, 301 East 17th Street, New York, NY 10038
View Disclosures and Other Information
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Synthes Spine. In addition, one or more of the authors or a member of his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from commercial entities (Synthes Spine, Spine Solutions).

A commentary by Andrew J. Schoenfeld, MD, is available at www.jbjs.org/commentary and is linked to the online version of this article.
Investigation performed at The Spine Institute at Saint John's Health Center, Santa Monica, California; Texas Back Institute/Texas Health Research Institute, Plano, Texas; Pennsylvania Hospital, Philadelphia, Pennsylvania; New York University Medical Center/Hospital for Joint Diseases Spine Center, New York, NY; CORE Orthopaedic Medical Center, Encinitas, California; Saint Mary's Spine Center, San Francisco, California; Yale University, New Haven, Connecticut; Haider Spine Center Medical Clinic, Inc., Riverside, California; Orthopedic Spine Associates, LLC, Eugene, Oregon; Hospital for Special Surgery, New York, NY; Texas Spine and Joint Hospital, Tyler, Texas; Michigan Brain & Spine Institute PC, Ypsilanti, Michigan; Watkins Spine Group, Marina del Rey, California; State University of New York Syracuse, Syracuse, New York; Twin Cities Orthopedics, Edina, Minnesota; and William Beaumont Hospital, Royal Oak, Michigan

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Apr 20;93(8):705-715. doi: 10.2106/JBJS.I.00680
A commentary by Andrew J. Schoenfeld, MD, is available here
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Abstract

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.

Level of Evidence: 

Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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