Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

This study is not yet open for participant recruitment.

Verified December 2012 by Lawson Health Research Institute

Sponsor:

Information provided by (Responsible Party):

gathwal@uwo.ca, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT01744314

First received: November 19, 2012

Last updated: December 5, 2012

Last verified: December 2012

History of Changes

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.

Condition	Intervention
Elbow Trauma Requiring Operative Management	Drug: Indomethacin and Pantoprazole Drug: microcrystalline cellulose powder tablets

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds

Drug Information available for: Indomethacin Cellulose, microcrystalline Pantoprazole Pantoprazole sodium

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

change 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.

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.

Estimated Enrollment:	150
Study Start Date:	November 2012
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744314

Contacts

Contact: George Athwal, MD	519-646-6100 ext 66081	<gathwal@uwo.ca>
Contact: Kate Kelly, MSc, MPH	519-646-6100 ext 64640	Kate.Kelly@sjhc.london.on.ca

Locations

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

Sponsors and Collaborators

Lawson Health Research Institute

More Information

Additional Information:

Canadian Orthopaedic Association This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	gathwal@uwo.ca, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01744314 History of Changes
Other Study ID Numbers:	102903
Study First Received:	November 19, 2012
Last Updated:	December 5, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis

Additional relevant MeSH terms:

Ossification, Heterotopic
Wounds and Injuries
Pathologic Processes
Indomethacin
Pantoprazole
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013

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