Naproxen for the Prevention of HO After Complex Elbow Trauma

Heterotopic Ossification Clinical Trial

— Naproxen  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00586365
• Other study ID #: 2006-P-001670
• Status: Withdrawn
• Phase: Phase 4
• First received: December 14, 2007
• Last updated: March 20, 2012
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: March 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heterotopic Ossification
• Ossification, Heterotopic

Intervention

Drug:
• Naproxen
500 mg Naproxen twice a day for two weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Viola RW, Hastings H 2nd. Treatment of ectopic ossification about the elbow. Clin Orthop Relat Res. 2000 Jan;(370):65-86. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There is no difference in ulnohumeral flexion		2 weeks	Yes