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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by University of British Columbia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818987
First Posted: January 8, 2009
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of British Columbia
  Purpose
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.

Condition Intervention Phase
3 and 4 Part Proximal Humerus Fractures Other: Open reduction internal fixation; reduction and immobilization Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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 [ Time Frame: 1 year ]

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 [ Time Frame: 1 year ]

Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Operative
Treatment arm - intervention = Open Reduction Internal Fixation or Reduction & Immobilization
Other: Open reduction internal fixation; reduction and immobilization
No Intervention: Non Operative
Placebo arm

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proximal humerus fracture patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818987


Contacts
Contact: Raman Johal 604-875-5239 raman.johal@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Raman Johal    604-875-5239    raman.johal@vch.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Pierre Guy, MDCM, MBA, FRCS(C) University of British Columbia
  More Information

Responsible Party: Pierre Guy, University of British Columbia
ClinicalTrials.gov Identifier: NCT00818987     History of Changes
Other Study ID Numbers: H08-02149
First Submitted: January 6, 2009
First Posted: January 8, 2009
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by University of British Columbia:
Operative
Non operative

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries