Elbow Trauma Requiring Operative Management Clinical Trial
Official title:
Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | November 2019 |
| Est. primary completion date | November 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | HULC, St Joseph's Health Care | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Patient Rate Elbow Evaluation | is a 20-item questionnaire designed to measure elbow pain and disability | 6 weeks and 3, 6 and 12 mfup | |
| Secondary | 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 | |
| Secondary | 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 |