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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 3 and 4 Part Proximal Humerus Fractures
- Sponsor
- University of British Columbia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Proximal humerus fracture patients
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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(1 year)