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Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures

Primary Purpose

3 and 4 Part Proximal Humerus Fractures

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Open reduction internal fixation; reduction and immobilization
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 3 and 4 Part Proximal Humerus Fractures focused on measuring Operative, Non operative

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Proximal humerus fracture patients

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Operative

Non Operative

Arm Description

Treatment arm - intervention = Open Reduction Internal Fixation or Reduction & Immobilization

Placebo arm

Outcomes

Primary Outcome Measures

Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

Secondary Outcome Measures

Functional and mental status instruments (i.e. SF-36/EQ-5D) used to assess the patient's health-related quality of life;, re-operation rates; and the time required to return to pre-injury level of independence

Full Information

First Posted
January 6, 2009
Last Updated
February 17, 2011
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00818987
Brief Title
Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures
Official Title
A Multicentre Prospective Randomized Control Trial on the Treatment of Three and Four Part Proximal Humerus Fractures in Patients 70 Years and Older: Comparing Open Reduction and Internal Fixation With Non Operative Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if operative treatment of non operative management of these fractures is best. Hypothesis: There is no difference in functional outcome between operative and non-operatively treated 3- and 4-part proximal humerus fractures at one year's time.
Detailed Description
Participants of 70 years of age or older who have been medically assessed as 'fit for surgery' are randomly (like flipping a coin) to either operative or non operative management of their injury. Clinical follow-up including x-rays, and physical assessment of injured shoulder, and outcomes questionnaires will be used to determine which if either resulted in the best outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
3 and 4 Part Proximal Humerus Fractures
Keywords
Operative, Non operative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Other
Arm Description
Treatment arm - intervention = Open Reduction Internal Fixation or Reduction & Immobilization
Arm Title
Non Operative
Arm Type
No Intervention
Arm Description
Placebo arm
Intervention Type
Other
Intervention Name(s)
Open reduction internal fixation; reduction and immobilization
Primary Outcome Measure Information:
Title
Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Functional and mental status instruments (i.e. SF-36/EQ-5D) used to assess the patient's health-related quality of life;, re-operation rates; and the time required to return to pre-injury level of independence
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Proximal humerus fracture patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raman Johal
Phone
604-875-5239
Email
raman.johal@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Guy, MDCM, MBA, FRCS(C)
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raman Johal
Phone
604-875-5239
Email
raman.johal@vch.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived

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Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures

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