Clinical Trial: Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Brief Summary:
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
Detailed Summary: This study is a prospective, randomized, controlled clinical trial.
Sponsor: Walter Reed National Military Medical Center
Current Primary Outcome: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ]
Original Primary Outcome: Prophylaxis of Heterotopic Ossification (HO) in wartime extremity injuries, a randomized clinical trial. [ Time Frame: 3 years ]
- Incidence of HO in patients with wartime extremity injuries.
- Severity of HO in this patient population.
Current Secondary Outcome: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ]
- Overall rate of impaired wound healing.
- Overall time to fracture union (if applicable)
- Overall rate of nonunions (if applicable)
- Overall rate of drug-related complications
Original Secondary Outcome: Prophylaxis of Heterotopic Ossification in wartime extremity injuries, a randomized clinical trial. [ Time Frame: 3 years ]
- Overall rate of impaired wound healing.
- Overall time to fracture union (if applicable)
- Overall rate of nonunions (if applicable)
- Overall rate of drug-related complications
Information By: Walter Reed National Military Medical Center
Dates:
Date Received: June 27, 2012
Date Started: May 2012
Date Completion: June 2018
Last Updated: June 29, 2012
Last Verified: June 2012