Naproxen for the Prevention of HO After Complex Elbow Trauma

Study Overview
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Brief Summary
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Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs. Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip. The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.

Official Title
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Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial

Conditions
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Heterotopic Ossification

Intervention / Treatment
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* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18 years or greater Operative treatment of one of the following injuries An elbow dislocation with or without associated fractures An olecranon fracture-dislocation, but not simple olecranon fractures A distal humerus fracture Exclusion Criteria: An existing diagnosis of one of the following conditions Injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications Fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion History of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding Impaired renal function (creatinine > 2.0), hypovolemia, heart failure, high blood pressure ( > 160/90), fluid retention, asthma, liver dysfunction (bilirubin > 2.0), or a coagulation disorder Allergy to non-steroidal anti-inflammatory medications Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs Considerable dehydration Pregnant or breast-feeding women Concomitant use of one of the following drugs: Aspirin Other naproxen products (ec-naprosyn, anaprox, anaprox ds, naprosyn suspension, aleve) Methotrexate Diuretics (thiazides / furosemide) ACE-inhibitors (captopril, enalapril, ramipril etc.) Beta-blockers (propanolol etc.) Probenecid (for gout or hyperuricemia) H2-blockers, sucralfate and intensive antacid therapy Lithium Anticoagulants / Warfarin (coumadin, waran, jantoven etc.) Sulfonamides Anticonvulsant medication (peganone, mesantoin, cerebyx, dilantin, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Will receive 500 mg Naproxen twice a day for two weeks | Drug: Naproxen<br>* 500 mg Naproxen twice a day for two weeks<br>|
| No Intervention: 2<br>Will not receive naproxen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There is no difference in ulnohumeral flexion |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complex elbow trauma, prevention, complication, naproxen, NSAIDS