• Huub J L van der Heide, Rinco C T Koorevaar, J Albert M Lemmens, Albert van Kampen, and B Willem Schreurs.
• Department of Orthopedics 800, Radboud University Medical Center, P.O. Box 9100, 6500 HB, Nijmegen, The Netherlands.
• Arch Orthop Trauma Surg. 2007 Sep 1;127(7):557-61.

IntroductionNonsteroidal 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 MethodsA 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.ResultsNo heterotopic ossification was found in 81% of the patients, 19% of the patients had Brooker grade 1 ossification.ConclusionUsing 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.

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