Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 26, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
HULC, St Joseph's Health Care 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:
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: May 26, 2014
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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 22, 2014