Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures
Phase 1
- Conditions
- 3 and 4 Part Proximal Humerus Fractures
- Interventions
- Other: Open reduction internal fixation; reduction and immobilization
- Registration Number
- NCT00818987
- Lead Sponsor
- University of British Columbia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Proximal humerus fracture patients
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Operative Open reduction internal fixation; reduction and immobilization Treatment arm - intervention = Open Reduction Internal Fixation or Reduction \& Immobilization
- Primary Outcome Measures
Name Time Method Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada