Elbow Trauma Requiring Operative Management
Conditions
Keywords
Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis
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.
Interventions
DRUGIndomethacin and Pantoprazole
DRUGmicrocrystalline cellulose powder tablets
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in post operative radiographic evaluation | 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
| Measure | Time frame | Description |
|---|---|---|
| change in range of motion | 6 weeks and 3, 6 and 12 mfup | measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup |
| Patient Rate Elbow Evaluation | 6 weeks and 3, 6 and 12 mfup | is a 20-item questionnaire designed to measure elbow pain and disability |
| The Mayo Elbow Performance score | 6 weeks and 3, 6 and 12 mfup | is an instrument used to test the limitations to use the elbow during ADL caused by the pathology |
| Disabilities of the Arm, Shoulder and Hand | 6 weeks and 3, 6 and 12 mfup | 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. |
Countries
Canada
Contacts
Primary ContactGeorge Athwal, MD
Backup ContactKate Kelly, MSc, MPH
Outcome results
None listed