Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

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

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.

Study Overview

• Status: Unknown
• Conditions: Elbow Trauma Requiring Operative Management
• Intervention / Treatment: Drug: Indomethacin and Pantoprazole; Drug: microcrystalline cellulose powder tablets

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George Athwal, MD; Phone Number: 66081 519-646-6100; Email: <gathwal@uwo.ca>
• Study Contact Backup: Name: Kate Kelly, MSc, MPH; Phone Number: 64640 519-646-6100; Email: Kate.Kelly@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Recruiting
      • HULC, St Joseph's Health Care
      • Contact: George Athwal, MD; Phone Number: 519-646-6100; Email: gathwal@uwo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drug; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in post operative radiographic evaluation	AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively.	6 weeks and 3, 6 and 12 mfup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in range of motion	measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup	6 weeks and 3, 6 and 12 mfup
Patient Rate Elbow Evaluation	is a 20-item questionnaire designed to measure elbow pain and disability	6 weeks and 3, 6 and 12 mfup
The Mayo Elbow Performance score	is an instrument used to test the limitations to use the elbow during ADL caused by the pathology	6 weeks and 3, 6 and 12 mfup
Disabilities of the Arm, Shoulder and Hand	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.	6 weeks and 3, 6 and 12 mfup

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Publications and helpful links

Helpful Links

• Canadian Orthopaedic Association

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Ossification, Heterotopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Gout Suppressants; Tocolytic Agents; Indomethacin; Pantoprazole
• Other Study ID Numbers: 102903