Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
- •Extremity Wound ≥75cm2 requiring operative intervention
- •Minimal age of 18 years
Exclusion Criteria
- •The following co-morbidities will result in exclusion from study:
- •Coronary Artery Disease,
- •Diabetes Mellitus (IDDM or T2DM),
- •Peripheral Vascular Disease,
- •Connective tissue disorders,
- •Immunosuppression,
- •Clinically-evident peptic ulcer disease,
- •Substantial renal dysfunction (as assessed by a serum creatinine \>1.5 or calculated creatinine clearance of \<50),
- •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,
- •Severe penetrating or hemorrhagic traumatic brain injury,
Arms & Interventions
Celebrex
Receive Celebrex
Intervention: Celecoxib (Drug)
Outcomes
Primary Outcomes
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Time Frame: 3 years
Incidence and severity of HO
Secondary Outcomes
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial(3 years)