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 ]

Incidence and severity of HO


Original Primary Outcome: Prophylaxis of Heterotopic Ossification (HO) in wartime extremity injuries, a randomized clinical trial. [ Time Frame: 3 years ]

  1. Incidence of HO in patients with wartime extremity injuries.
  2. 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 ]

  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


Original Secondary Outcome: Prophylaxis of Heterotopic Ossification in wartime extremity injuries, a randomized clinical trial. [ Time Frame: 3 years ]

  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


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