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Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by George Athwal, Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
George Athwal, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01744314
First received: November 19, 2012
Last updated: March 22, 2017
Last verified: March 2017
  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: Quadruple (Participant, Care Provider, 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 George Athwal, Lawson Health Research Institute:

Primary Outcome Measures:
  • change in post operative radiographic evaluation [ Time Frame: 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:
  • change in range of motion [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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:
Responsible Party: George Athwal, 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: March 22, 2017

Keywords provided by George Athwal, Lawson Health Research Institute:
Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis

Additional relevant MeSH terms:
Wounds and Injuries
Ossification, Heterotopic
Pathologic Processes
Pantoprazole
Indomethacin
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017