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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00818987
First received: January 6, 2009
Last updated: February 17, 2011
Last verified: February 2011
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proximal humerus fracture patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pierre Guy, University of British Columbia
ClinicalTrials.gov Identifier: NCT00818987     History of Changes
Other Study ID Numbers: H08-02149
Study First Received: January 6, 2009
Last Updated: February 17, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Operative
Non operative

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

ClinicalTrials.gov processed this record on October 22, 2014