Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01631669

Enrollment

100

Registered

2012-06-29

Start date

2012-05-31

Completion date

2018-06-30

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ossification, Heterotopic

Keywords

Ossification, Heterotopic Ossification

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.

Interventions

DRUGCelecoxib

200 mg Q 12 hours orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany, United States

Contacts

Primary ContactJonathan A Forsberg, MD

jonathan.forsberg@med.navy.mil301-319-3403

Backup ContactFrederick A Gage

frederick.gage@med.navy.mil301-319-8592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026