Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Not Applicable

• Conditions: Ossification, Heterotopic
• Interventions: Drug: Celecoxib

• Registration Number: NCT01631669
• Lead Sponsor: Walter Reed National Military Medical Center

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 Description

This study is a prospective, randomized, controlled clinical trial.

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03
• Primary Completion: 2015-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

The following co-morbidities will result in exclusion from study:

1. Coronary Artery Disease,
2. Diabetes Mellitus (IDDM or T2DM),
3. Peripheral Vascular Disease,
4. Age >65,
5. Connective tissue disorders,
6. Immunosuppression,
7. Clinically-evident peptic ulcer disease,
8. Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50),
9. 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,
10. Severe penetrating or hemorrhagic traumatic brain injury,
11. Endoscopic gastrointestinal interventions,
12. Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
13. Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
14. History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
15. Hepatic Impairment
16. Warfarin
17. Lithium
18. Drugs known to inhibit CYP2C9 Liver Enzymes
19. Subjects known or suspected to be poor CYP2C9 metabolizers
20. Concomitant use with ACE Inhibitors and Angiotension II Antagonists

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celebrex	Celecoxib	Receive Celebrex

Primary Outcome Measures

Name	Time	Method
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial	3 years	Incidence and severity of HO

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Walter Reen National Military Medical Center Bethesda; 🇺🇸 Bethesda, Maryland, United States

Landstuhl Military Medical Center; 🇩🇪 Landstuhl, Germany