Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Overview[ - collapse ][ - ]

Purpose 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.
ConditionElbow Trauma Requiring Operative Management
InterventionDrug: Indomethacin and Pantoprazole
Drug: microcrystalline cellulose powder tablets
PhaseN/A
SponsorLawson Health Research Institute
Responsible PartyLawson Health Research Institute
ClinicalTrials.gov IdentifierNCT01744314
First ReceivedNovember 19, 2012
Last UpdatedDecember 5, 2012
Last verifiedDecember 2012

Tracking Information[ + expand ][ + ]

First Received DateNovember 19, 2012
Last Updated DateDecember 5, 2012
Start DateNovember 2012
Estimated Primary Completion DateNovember 2015
Current Primary Outcome Measureschange 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.
Current Secondary Outcome Measures
  • 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.

Descriptive Information[ + expand ][ + ]

Brief TitleIndomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
Official TitleIndomethacin 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 DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionElbow Trauma Requiring Operative Management
InterventionDrug: Indomethacin and Pantoprazole
Drug: microcrystalline cellulose powder tablets
Study Arm (s)
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment150
Estimated Completion DateNovember 2015
Estimated Primary Completion DateNovember 2014
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: George Athwal, MD
519-646-6100

Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT01744314
Other Study ID Numbers102903
Has Data Monitoring CommitteeNo
Information Provided ByLawson Health Research Institute
Study SponsorLawson Health Research Institute
CollaboratorsNot Provided
Investigators Not Provided
Verification DateDecember 2012

Locations[ + expand ][ + ]

St Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Contact: George Athwal, MD | 519-646-6100 | gathwal@uwo.ca
Not yet recruiting