Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Study Overview
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Brief Summary
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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.

Official Title
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Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.

Conditions
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Elbow Trauma Requiring Operative Management

Intervention / Treatment
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* Drug: Indomethacin and Pantoprazole
* Drug: microcrystalline cellulose powder tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug<br>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. | Drug: Indomethacin and Pantoprazole<br> <br> |
| Placebo Comparator: placebo<br>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. | Drug: microcrystalline cellulose powder tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in post operative radiographic evaluation | AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively. | 6 weeks and 3, 6 and 12 mfup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in range of motion | measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup | 6 weeks and 3, 6 and 12 mfup | 
| Patient Rate Elbow Evaluation | is a 20-item questionnaire designed to measure elbow pain and disability | 6 weeks and 3, 6 and 12 mfup | 
| The Mayo Elbow Performance score | is an instrument used to test the limitations to use the elbow during ADL caused by the pathology | 6 weeks and 3, 6 and 12 mfup | 
| Disabilities of the Arm, Shoulder and Hand | is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | 6 weeks and 3, 6 and 12 mfup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis