Hypotheses: H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls. H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification. H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification
This study is a prospective, randomized, controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
200 mg Q 12 hours orally
Walter Reen National Military Medical Center Bethesda
Bethesda, Maryland, United States
RECRUITINGLandstuhl Military Medical Center
Landstuhl, Germany
RECRUITINGProphylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Incidence and severity of HO
Time frame: 3 years
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
1. Overall rate of impaired wound healing. 2. Overall time to fracture union (if applicable) 3. Overall rate of nonunions (if applicable) 4. Overall rate of drug-related complications
Time frame: 3 years
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