Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.
Overview
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- change in post operative radiographic evaluation
Overview
Brief Summary
Patients who present to our institution with a traumatic injury to their elbow who need operative management will be randomized to one of two groups; a treatment arm and a control arm. The treatment arm will receive a three-week postoperative course of indomethacin while the control group will not. We will follow both groups to assess whether or not indomethacin prophylaxis affects the rate of heterotopic ossification.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Terrible Triad
- •Radial head fracture surgical treatment
- •Monteggia and Trans-olecranon Fracture Dislocations
- •Distal Biceps Tendon Injuries
- •Distal Humerus Fractures
- •Coronoid Fractures
- •Capitellar-Trochlear fractures
- •Olecranon Fractures
Exclusion Criteria
- •Associated Traumatic Brain Injury
- •Burn Injuries associated with elbow trauma
- •History of Gastric Ulcers
- •Documented allergies to any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- •Severe Asthma
- •Previous operative fixation to affected elbow
- •Participation in other research study
- •Inability to speak / understand English
Arms & Interventions
drug
The treatment arm will receive 21 days of Indomethacin and Pantoprazole (gastrointestinal protective agent). The patients will receive Indomethacin 25mg three times a day and Pantoprozole 40mg once a day.
Intervention: Indomethacin and Pantoprazole (Drug)
placebo
The placebo group will receive microcrystalline cellulose powder tablets to be taken as a control. The placebo will be dosed at the same intervals and duration as the treatment arm in this study.
Intervention: microcrystalline cellulose powder tablets (Drug)
Outcomes
Primary Outcomes
change in post operative radiographic evaluation
Time Frame: 6 weeks and 3, 6 and 12 mfup
AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively.
Secondary Outcomes
- change in range of motion(6 weeks and 3, 6 and 12 mfup)
- Patient Rate Elbow Evaluation(6 weeks and 3, 6 and 12 mfup)
- The Mayo Elbow Performance score(6 weeks and 3, 6 and 12 mfup)
- Disabilities of the Arm, Shoulder and Hand(6 weeks and 3, 6 and 12 mfup)
Investigators
George Athwal
Associate Professor
Lawson Health Research Institute