Naproxen for the Prevention of HO After Complex Elbow Trauma

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00586365

Acronym

Naproxen

Enrollment

Registered

2008-01-04

Start date

2007-10-31

Completion date

2010-10-31

Last updated

2012-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heterotopic Ossification

Keywords

complex elbow trauma, prevention, complication, naproxen, NSAIDS

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.

Interventions

DRUGNaproxen

500 mg Naproxen twice a day for two weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame
There is no difference in ulnohumeral flexion	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026