Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
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ClinicalTrials.gov Identifier: NCT01631669 |
Recruitment Status
:
Recruiting
First Posted
: June 29, 2012
Last Update Posted
: July 3, 2012
|
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ossification, Heterotopic | Drug: Celecoxib | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | June 2015 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Celebrex
Receive Celebrex
|
Drug: Celecoxib
200 mg Q 12 hours orally
Other Name: Celebrex
|
No Intervention: Control
no placebo administered
|
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ]Incidence and severity of HO
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ]
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631669
Contact: Jonathan A Forsberg, MD | 301-319-3403 | jonathan.forsberg@med.navy.mil | |
Contact: Frederick A Gage | 301-319-8592 | frederick.gage@med.navy.mil |
United States, Maryland | |
Walter Reen National Military Medical Center Bethesda | Recruiting |
Bethesda, Maryland, United States, 20889 | |
Contact: Jonathan A Forsberg, MD 301-319-3403 jonathan.forsberg@med.navy.mil | |
Contact: Frederick A Gage 301-319-8592 frederick.gage@med.navy.mil | |
Principal Investigator: Jonathan A Forsberg, MD | |
Sub-Investigator: Benjamin K Potter, MD | |
Sub-Investigator: Eric A Elster, MD | |
Sub-Investigator: Frederick A Gage | |
Sub-Investigator: Felipe Lisboa, MD | |
Sub-Investigator: Tala Ghadimi, BS | |
Germany | |
Landstuhl Military Medical Center | Recruiting |
Landstuhl, Germany | |
Contact: Brett Freedman, MD brett.freedman@amedd.army.mil | |
Principal Investigator: Brett Freedman, MD | |
Sub-Investigator: Hunter Martin, PhD |
Principal Investigator: | Jonathan A Forsberg, MD | Walter Reed National Military Medical Center |
Publications:
Responsible Party: | Walter Reed National Military Medical Center |
ClinicalTrials.gov Identifier: | NCT01631669 History of Changes |
Other Study ID Numbers: |
352511 110587 ( Other Identifier: FDA IND ) |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | July 3, 2012 |
Last Verified: | June 2012 |
Keywords provided by Walter Reed National Military Medical Center:
Ossification Heterotopic Ossification |
Additional relevant MeSH terms:
Ossification, Heterotopic Pathologic Processes Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |