Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

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

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