Naproxen for the Prevention of HO After Complex Elbow Trauma
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heterotopic Ossification
Intervention: Naproxen (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
David Ring, MD PhD, Study Director, Affiliation: Mass General
Overall contact:
Kim M Brouwer, MSc, Phone: 6716432144, Email: kbrouwer@partners.org
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.
Clinical Details
Official title: Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
Study design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: There is no difference in ulnohumeral flexion
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.)
Locations and Contacts
Kim M Brouwer, MSc, Phone: 6716432144, Email: kbrouwer@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Kim M Browuer, MSc, Phone: 617-643-2144, Email: kbrouwer@partners.org
Kim M Brouwer, MSc, Sub-Investigator
David Ring, MD, PhD, Principal Investigator
Additional Information
Related publications: Viola RW, Hastings H 2nd. Treatment of ectopic ossification about the elbow. Clin Orthop Relat Res. 2000 Jan;(370):65-86. Review.
Starting date: October 2007
Ending date: October 2010
Last updated: June 23, 2008
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