Proximal Humeral Fractures
Conditions
Keywords
Shoulder fractures, Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus
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.
Interventions
Non-surgical management (physiotherapy and self-training)
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
Primary modular hemiarthroplasty followed by physiotherapy and self-training
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant Disability Scale | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Oxford Shoulder Score, Short Form-36 | 3 years |
Countries
Denmark