Naproxen for the Prevention of HO After Complex Elbow Trauma

Phase 4

Withdrawn

• Conditions: Heterotopic Ossification
• Interventions: Drug: Naproxen

• Registration Number: NCT00586365
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-04
• Primary Completion: 2010-01
• Study Completion: 2010-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects aged 18 years or greater

2. 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

1. 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

2. Pregnant or breast-feeding women

3. 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Naproxen	Will receive 500 mg Naproxen twice a day for two weeks

Primary Outcome Measures

Name	Time	Method
There is no difference in ulnohumeral flexion	2 weeks

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States