Naproxen for the Prevention of HO After Complex Elbow Trauma - Tabular View

Tracking Information

First Received Date ^ICMJE

December 14, 2007

Last Updated Date

September 30, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

There is no difference in ulnohumeral flexion [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00586365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Naproxen for the Prevention of HO After Complex Elbow Trauma

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Heterotopic Ossification

Intervention ^ICMJE

Drug: Naproxen

Study Arms / Comparison Groups

Experimental: Will receive 500 mg Naproxen twice a day for two weeks
No Intervention: Will not receive naproxen

Publications *

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

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kim M Brouwer, MSc	6716432144	kbrouwer@partners.org
Contact: David Ring, MD, PHd	6176432144	dring@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00586365

Responsible Party

David Ring, Massachusetts General Hospital

Study ID Numbers ^ICMJE

2006-P-001670

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

David Ring, MD PhD

Mass General

Information Provided By

Massachusetts General Hospital

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP