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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin and Pantoprazole | Drug |
| ||
| microcrystalline cellulose powder tablets |
| Measure | Description | Time Frame |
|---|---|---|
| change in post operative radiographic evaluation | AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively. | 6 weeks and 3, 6 and 12 mfup |
| Measure | Description | Time Frame |
|---|---|---|
| change in range of motion | measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup | 6 weeks and 3, 6 and 12 mfup |
| Patient Rate Elbow Evaluation | is a 20-item questionnaire designed to measure elbow pain and disability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Athwal, MD | Contact | 519-646-6100 | 66081 | <gathwal@uwo.ca> |
| Kate Kelly, MSc, MPH | Contact | 519-646-6100 | 64640 | Kate.Kelly@sjhc.london.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HULC, St Joseph's Health Care | Recruiting | London | Ontario | N6A 4V2 | Canada |
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| Label | URL |
|---|---|
| Canadian Orthopaedic Association | View source |
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| Drug |
|
| 6 weeks and 3, 6 and 12 mfup |
| The Mayo Elbow Performance score | is an instrument used to test the limitations to use the elbow during ADL caused by the pathology | 6 weeks and 3, 6 and 12 mfup |
| Disabilities of the Arm, Shoulder and Hand | 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. | 6 weeks and 3, 6 and 12 mfup |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
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