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Naproxen for the Prevention of HO After Complex Elbow Trauma (Naproxen)

Primary Purpose

Heterotopic Ossification

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naproxen
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heterotopic Ossification focused on measuring complex elbow trauma, prevention, complication, naproxen, NSAIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Will receive 500 mg Naproxen twice a day for two weeks

Will not receive naproxen

Outcomes

Primary Outcome Measures

There is no difference in ulnohumeral flexion

Secondary Outcome Measures

Full Information

First Posted
December 14, 2007
Last Updated
March 20, 2012
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00586365
Brief Title
Naproxen for the Prevention of HO After Complex Elbow Trauma
Acronym
Naproxen
Official Title
Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Too difficult to satisfy all the inclusion criteria.
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterotopic Ossification
Keywords
complex elbow trauma, prevention, complication, naproxen, NSAIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Will receive 500 mg Naproxen twice a day for two weeks
Arm Title
2
Arm Type
No Intervention
Arm Description
Will not receive naproxen
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
500 mg Naproxen twice a day for two weeks
Primary Outcome Measure Information:
Title
There is no difference in ulnohumeral flexion
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD PhD
Organizational Affiliation
Mass General
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10660703
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.
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Naproxen for the Prevention of HO After Complex Elbow Trauma

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