Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01744314|
Recruitment Status : Recruiting
First Posted : December 6, 2012
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment|
|Elbow Trauma Requiring Operative Management||Drug: Indomethacin and Pantoprazole Drug: microcrystalline cellulose powder tablets|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
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|
- 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.
- change in range of motion [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744314
|Contact: George Athwal, MD||519-646-6100 ext 66081||<firstname.lastname@example.org>|
|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 email@example.com|