Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Status unconfirmed · Not applicable

Conditions studied: Ossification, Heterotopic

In brief

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

Key facts

Study ID

NCT01631669

Run by

Walter Reed National Military Medical Center

People needed

100

Starts

2012-05-01

Expected to finish

2018-06-01

Last updated by the study team

2012-07-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• The following co-morbidities will result in exclusion from study:
• 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),
• Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
• Severe penetrating or hemorrhagic traumatic brain injury,
• Endoscopic gastrointestinal interventions,
• Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
• Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
• History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
• Hepatic Impairment
• Warfarin
• Lithium
• Drugs known to inhibit CYP2C9 Liver Enzymes
• Subjects known or suspected to be poor CYP2C9 metabolizers
• Concomitant use with ACE Inhibitors and Angiotension II Antagonists

Where it is running

• Walter Reen National Military Medical Center Bethesda — Bethesda, Maryland, United States (enrolling)
• Landstuhl Military Medical Center — Landstuhl, Germany (enrolling)

Full record on ClinicalTrials.gov

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