Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
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.
Elbow Trauma Requiring Operative Management
Drug: Indomethacin and Pantoprazole
Drug: microcrystalline cellulose powder tablets
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.|
- change in post operative radiographic evaluation [ Time Frame: 6 weeks and 3, 6 and 12 mfup ] [ Designated as safety issue: No ]AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively.
- change in range of motion [ Time Frame: 6 weeks and 3, 6 and 12 mfup ] [ Designated as safety issue: No ]measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup
- Patient Rate Elbow Evaluation [ Time Frame: 6 weeks and 3, 6 and 12 mfup ] [ Designated as safety issue: No ]is a 20-item questionnaire designed to measure elbow pain and disability
- The Mayo Elbow Performance score [ Time Frame: 6 weeks and 3, 6 and 12 mfup ] [ Designated as safety issue: No ]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 [ Time Frame: 6 weeks and 3, 6 and 12 mfup ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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|
Placebo Comparator: 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.
|Drug: microcrystalline cellulose powder tablets|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744314
|Contact: George Athwal, MD||519-646-6100 ext 66081||<email@example.com>|
|Contact: Kate Kelly, MSc, MPH||519-646-6100 ext 64640||Kate.Kelly@sjhc.london.on.ca|
|HULC, St Joseph's Health Care||Recruiting|
|London, Ontario, Canada, N6A 4V2|
|Contact: George Athwal, MD 519-646-6100 firstname.lastname@example.org|