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

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00586365

Purpose

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.

Condition	Intervention	Phase
Heterotopic Ossification	Drug: Naproxen	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial

Resource links provided by NLM:

Genetics Home Reference related topics: progressive osseous heteroplasia

MedlinePlus related topics: Injuries Wounds

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	October 2007
Study Completion Date:	October 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586365

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Study Director:

David Ring, MD PhD

Mass General

More Information

Publications:

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

Responsible Party:	David Ring, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00586365 History of Changes
Other Study ID Numbers:	2006-P-001670
Study First Received:	December 14, 2007
Last Updated:	July 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

complex elbow trauma
prevention
complication
naproxen
NSAIDS

Additional relevant MeSH terms:

Ossification, Heterotopic
Pathologic Processes
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012