Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
NCT ID: NCT01631669
Last Updated: 2012-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2012-05-31
2018-06-30
Brief Summary
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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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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Celebrex
Receive Celebrex
Celecoxib
200 mg Q 12 hours orally
Control
no placebo administered
No interventions assigned to this group
Interventions
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Celecoxib
200 mg Q 12 hours orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Extremity Wound ≥75cm2 requiring operative intervention
3. Minimal age of 18 years
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Walter Reed National Military Medical Center
FED
Responsible Party
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Principal Investigators
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Jonathan A Forsberg, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center
Locations
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Walter Reen National Military Medical Center Bethesda
Bethesda, Maryland, United States
Landstuhl Military Medical Center
Landstuhl, , Germany
Countries
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Central Contacts
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Facility Contacts
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Jonathan A Forsberg, MD
Role: primary
Frederick A Gage
Role: backup
Brett Freedman, MD
Role: primary
References
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Forsberg JA, Pepek JM, Wagner S, Wilson K, Flint J, Andersen RC, Tadaki D, Gage FA, Stojadinovic A, Elster EA. Heterotopic ossification in high-energy wartime extremity injuries: prevalence and risk factors. J Bone Joint Surg Am. 2009 May;91(5):1084-91. doi: 10.2106/JBJS.H.00792.
Potter BK, Burns TC, Lacap AP, Granville RR, Gajewski DA. Heterotopic ossification following traumatic and combat-related amputations. Prevalence, risk factors, and preliminary results of excision. J Bone Joint Surg Am. 2007 Mar;89(3):476-86. doi: 10.2106/JBJS.F.00412.
Other Identifiers
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110587
Identifier Type: OTHER
Identifier Source: secondary_id
352511
Identifier Type: -
Identifier Source: org_study_id