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. |
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Condition | Elbow Trauma Requiring Operative Management |
Intervention | Drug: Indomethacin and Pantoprazole Drug: microcrystalline cellulose powder tablets |
Phase | N/A |
Sponsor | Lawson Health Research Institute |
Responsible Party | Lawson Health Research Institute |
ClinicalTrials.gov Identifier | NCT01744314 |
First Received | November 19, 2012 |
Last Updated | December 5, 2012 |
Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | November 19, 2012 |
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Last Updated Date | December 5, 2012 |
Start Date | November 2012 |
Estimated Primary Completion Date | November 2015 |
Current 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. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma |
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Official Title | Indomethacin 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Elbow Trauma Requiring Operative Management |
Intervention | Drug: Indomethacin and Pantoprazole Drug: microcrystalline cellulose powder tablets |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 150 |
Estimated Completion Date | November 2015 |
Estimated Primary Completion Date | November 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: George Athwal, MD 519-646-6100 |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01744314 |
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Other Study ID Numbers | 102903 |
Has Data Monitoring Committee | No |
Information Provided By | Lawson Health Research Institute |
Study Sponsor | Lawson Health Research Institute |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | December 2012 |
Locations[ + expand ][ + ]
St Joseph's Health Care | London, Ontario, Canada, N6A 4V2 Contact: George Athwal, MD | 519-646-6100 | gathwal@uwo.caNot yet recruiting |
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