Naproxen for the Prevention of HO After Complex Elbow Trauma (Naproxen)

March 20, 2012 updated by: David C. Ring, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
There is no difference in ulnohumeral flexion
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Study Director: David Ring, MD PhD, Mass General

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-P-001670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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