Clinical trial NCT01631669: Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
Official title: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ossification, Heterotopic
Keywords: Ossification
Heterotopic Ossification
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2012-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
timeFrame: 3 years
Secondary outcomes:
measure: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
timeFrame: 3 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reen National Military Medical Center Bethesda
state: Maryland
city: Landstuhl
country: Germany
facility: Landstuhl Military Medical Center
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Jonathan A Forsberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.