Rofecoxib inhibits heterotopic ossification after total hip arthroplasty.
BACKGROUND
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.


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.


CONCLUSIONS
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.
van der Heide
Huub J L
HJ
Department of Orthopedics 800, Radboud University Medical Center, P.O. Box 9100, 6500 HB, Nijmegen, The Netherlands.
Koorevaar
Rinco C T
RC
Lemmens
J Albert M
JA
van Kampen
Albert
A
Schreurs
B Willem
BW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects*; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009999:Ossification, Heterotopic / Q000517:prevention & control*; D011446:Prospective Studies; D012107:Research Design; D013450:Sulfones / Q000627:therapeutic use*
D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib