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Clinical Issues   |    
Results and Lessons Learned from a United States Hip Resurfacing Investigational Device Exemption Trial
Bernard N. Stulberg, MD1; Kathy K. Trier, PhD2; Marybeth Naughton, BS3; Jayson D. Zadzilka, MS1
1 Cleveland Clinic Orthopaedic and Rheumatologic Institute, 1730 West 25th Street, 4E, Cleveland, OH 44113. E-mail address for B.N. Stulberg: stulbeb@ccf.org
2 Corin USA, 10500 University Center Drive, Suite 190, Tampa, FL 33612
3 Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430
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 Stryker Orthopaedics. 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 a commercial entity (Corin, Tampa, Florida). Commercial entities (Corin, Tampa, Florida, and Stryker, Mahwah, New Jersey) paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2008 Aug 01;90(Supplement 3):21-26. doi: 10.2106/JBJS.H.00718
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Abstract

Background: Improvements in metal-on-metal bearings have made hybrid hip surface replacement a potential alternative for the young active patient with end-stage hip disease. Possible advantages include greater hip joint stability, bone preservation, and decreased osteolysis. In this study, we compared the clinical and radiographic results of a new resurfacing device with those in a historical group of standard total hip arthroplasties.

Methods: In 2001, the Cormet 2000 Hip Resurfacing Investigational Device Exemption study was initiated at twelve centers. A total of 337 patients treated with unilateral hip surface replacement with the Cormet device were enrolled in that study. These patients were compared with 266 patients in a previous study who had undergone unilateral total hip arthroplasty with ceramic bearing surfaces. Clinical and radiographic results were compared at similar time intervals. A newly recommended performance standard, the composite clinical success score, was used to assess non-inferiority of the hip resurfacing compared with the total hip arthroplasty used in the historical comparison population.

Results: At the time of follow-up, at a minimum of two years, the Harris hip scores were comparable between the resurfacing and total hip arthroplasty groups. Statistical evaluation of the composite clinical success scores confirmed the non-inferiority hypothesis. Revision was required in twenty-four patients in the resurfacing group and five patients in the total hip arthroplasty group. The most common cause of revision following resurfacing was failure of the femoral component (fracture of the femoral neck or loosening of the femoral component).

Conclusions: Careful review of this study population revealed several important criteria for successful introduction of this resurfacing device into the United States. These include careful patient selection based on clinical and radiographic parameters and attention to various surgical details of implantation. These findings can be used to focus the training process for surgeons who wish to add implantation of this device to their surgical armamentarium. Such efforts should help to ensure safe and effective introduction of this new technology.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

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    Accreditation Statement
    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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