Clinical trial NCT00586365: Naproxen for the Prevention of HO After Complex Elbow Trauma
Official title: Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heterotopic Ossification
Keywords: complex elbow trauma
prevention
complication
naproxen
NSAIDS
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.)

Primary outcomes:
measure: There is no difference in ulnohumeral flexion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass General
name: David Ring, MD PhD
role: STUDY_DIRECTOR
References:
citation: Viola RW, Hastings H 2nd. Treatment of ectopic ossification about the elbow. Clin Orthop Relat Res. 2000 Jan;(370):65-86. doi: 10.1097/00003086-200001000-00008.