Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Study Overview
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Brief Summary
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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 Description
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This study is a prospective, randomized, controlled clinical trial.

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

Conditions
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Ossification, Heterotopic

Intervention / Treatment
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* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celebrex<br>Receive Celebrex | Drug: Celecoxib<br>* 200 mg Q 12 hours orally<br>* Other names: Celebrex;|
| No Intervention: Control<br>no placebo administered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial | Incidence and severity of HO | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial | 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 | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ossification, Heterotopic Ossification