Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Ossification, Heterotopic	Drug: Celecoxib	Not Applicable

Detailed Description:

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

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Celebrex; Receive Celebrex	Drug: Celecoxib; 200 mg Q 12 hours orally; Other Name: Celebrex
No Intervention: Control; no placebo administered

Outcome Measures

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Primary Outcome Measures :

1. Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ]
   Incidence and severity of HO

Secondary Outcome Measures :

1. Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Contacts

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

Locations

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

Sponsors and Collaborators

Walter Reed National Military Medical Center

Investigators

Principal Investigator:	Jonathan A Forsberg, MD	Walter Reed National Military Medical Center

More Information

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Publications:

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.

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
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