UnknownNot Applicable

Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

United States, Germany100 participantsStarted 2012-05

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
✓. Extremity Wound ≥75cm2 requiring operative intervention
✓. Minimal age of 18 years

Exclusion criteria

✕. Coronary Artery Disease,
✕. Diabetes Mellitus (IDDM or T2DM),
✕. Peripheral Vascular Disease,
✕. Age \>65,
✕. Connective tissue disorders,
✕. Immunosuppression,
✕. Clinically-evident peptic ulcer disease,
✕. Substantial renal dysfunction (as assessed by a serum creatinine \>1.5 or calculated creatinine clearance of \<50),

What they're measuring

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Timeframe: 3 years

Trial details

NCT IDNCT01631669

SponsorWalter Reed National Military Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2015-06

Contact for this trial

Jonathan A Forsberg, MD

301-319-3403 jonathan.forsberg@med.navy.mil

View on ClinicalTrials.gov More Ossification, Heterotopic trials