Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Herlev Hospital
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Constant Disability Scale
Study Overview
Brief Summary
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.
The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.
The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Displaced four-part fracture of the proximal humerus
- •Mentally alert
- •Physically fit for surgery and rehabilitation (ASA-group 1-3)
- •Informed written consent
- •Operation can be conducted within 2 weeks of injury
Exclusion Criteria
- •Fracture-dislocations
- •Head-splitting fractures
- •Previous shoulder surgery on injured side
- •Chronic shoulder pain
- •Abuse problems
- •Patients unable to understand instructions in Danish
Arms & Interventions
Hemiarthroplasty
Intervention: Hemiarthroplasty (Procedure)
Osteosynthesis
Intervention: Osteosynthesis (Procedure)
Non-surgical
Intervention: Non-surgical management (Procedure)
Outcomes
Primary Outcomes
Constant Disability Scale
Time Frame: 3 years
Secondary Outcomes
- Oxford Shoulder Score, Short Form-36(3 years)
Investigators
Stig Brorson
MD PhD
Herlev Hospital
