Clinical Trial: Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Lawson Health Research Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Lawson Health Research Institute

Dates:
Date Received: November 19, 2012
Date Started: November 2012
Date Completion: November 2019
Last Updated: March 22, 2017
Last Verified: March 2017