Banovac et al. 2004
USA
PEDro=10
RCT
N=76

Population: Gender: males = 65, females = 11; Severity of injury: complete, incomplete, AIS: A-C; Time since injury = 24 days.
Interventions: The treatment group received PO rofecoxib 25 mg daily X 4 wks.
Outcome Measures: incidence of heterotopic ossification and swelling of joint(s).

1. A significantly lower incidence of HO was found in rofecoxib group (13.4%) than in the placebo group (33.3%, p<0.05). 
2. In patients receiving rofecoxib, there was 2.5X lower relative risk of developing HO than in the placebo group.

Banovac et al. 2001
USA
PEDro=9
RCT
N=33

Population: Mean age = 33 yrs; Gender: males = 33; Severity of injury: AIS: A-D; Groups: treatment = 16, placebo = 17.
Treatment: Treatment was slow-release indomethacin 75mg daily vs. placebo X 3wks.  Pts were followed up clinically until they showed signs and symptoms of HO; all were followed up with x-rays q2mos X 6mos.  Where pts had evidence of a +ve nuclear bone scan for HO, the study was D/C and patient initiated on disodium etidronate.
Outcomes Measures: The effect of indomethacin administration on the incidence of heterotopic ossification.

1. There was a significantly higher incidence of early HO, diagnosed on nuclear bone scan, in the placebo group (11/17) than in the group taking indomethacin (4/16) (p<.001). 
2. In the placebo group, 7/17 pts developed x-ray evidence of HO as did 2/16 in the indomethacin treated group (p<.001).