Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Not Applicable

• Conditions: Elbow Trauma Requiring Operative Management
• Interventions: Drug: Indomethacin and Pantoprazole; Drug: microcrystalline cellulose powder tablets

• Registration Number: NCT01744314
• Lead Sponsor: Lawson Health Research Institute

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 Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-23
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug	Indomethacin and Pantoprazole	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.
placebo	microcrystalline cellulose powder tablets	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

HULC, St Joseph's Health Care; 🇨🇦 London, Ontario, Canada