NCT00586365

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

2.3 years

First QC Date

December 14, 2007

Last Update Submit

March 20, 2012

Conditions

Heterotopic Ossification

Keywords

complex elbow traumapreventioncomplicationnaproxenNSAIDS

Outcome Measures

Primary Outcomes (1)

  • There is no difference in ulnohumeral flexion

    2 weeks

Study Arms (2)

1

EXPERIMENTAL

Will receive 500 mg Naproxen twice a day for two weeks

Drug: Naproxen

2

NO INTERVENTION

Will not receive naproxen

Interventions

NaproxenDRUG

500 mg Naproxen twice a day for two weeks

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 10660703BACKGROUND

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • David Ring, MD PhD

    Mass General

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Hand Service

Study Record Dates

First Submitted

December 14, 2007

First Posted

January 4, 2008

Study Start

October 1, 2007

Primary Completion

January 1, 2010

Study Completion

October 1, 2010

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations

US(1)