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Rofecoxib inhibits heterotopic ossification after total hip arthroplasty.

van der Heide HJ, Koorevaar RC, Lemmens JA, van Kampen A, Schreurs BW

Department of Orthopedics 800, Radboud University Medical Center, P.O. Box 9100, 6500 HB, Nijmegen, The Netherlands, B.Schreurs@orthop.umcn.nl.

INTRODUCTION: Nonsteroidal anti-inflammatory drugs (NSAIDs) prevent heterotopic ossification but gastrointestinal complaints are frequently. Selective cyclooxygenase-2 (COX-2) inhibiting NSAID produce less gastrointestinal side effects. PATIENTS AND METHODS: A prospective two-stage study design for phase 2 clinical trials with 42 patients was used to determine if rofecoxib (a COX-2 inhibitor) 50 mg oral for 7 days prevents heterotopic ossification. A cemented primary THA was inserted for osteoarthroses. After 6 months heterotopic bone formation was assessed on AP radiographs using the Brooker classification. RESULTS: No heterotopic ossification was found in 81% of the patients, 19% of the patients had Brooker grade 1 ossification. CONCLUSION: Using a two-stage study design for phase 2 clinical trials, a 7-day treatment of a COX-2 inhibitor (rofecoxib) prevents effectively the formation of heterotopic ossification after cemented primary total hip arthroplasty.

Published 6 August 2007 in Arch Orthop Trauma Surg, 127(7): 557-61.
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