Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Ossification, Heterotopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01631669
• Other study ID #: 352511
• Secondary ID: 110587
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2012
• Last updated: June 29, 2012
• Start date: May 2012
• Est. completion date: June 2018

Study information

• Verified date: June 2012
• Source: Walter Reed National Military Medical Center
• Contact: Jonathan A Forsberg, MD
• Phone: 301-319-3403
• Email: jonathan.forsberg[@]med.navy.mil
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ossification, Heterotopic

Intervention

Drug:
• Celecoxib
200 mg Q 12 hours orally

Locations

Country	Name	City	State
Germany	Landstuhl Military Medical Center	Landstuhl
United States	Walter Reen National Military Medical Center Bethesda	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial	Incidence and severity of HO	3 years	Yes
Secondary	Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial	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	3 years	Yes