Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Proximal Humeral Fractures

Intervention / Treatment
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* Procedure: Non-surgical management
* Procedure: Osteosynthesis
* Procedure: Hemiarthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteosynthesis<br> | Procedure: Osteosynthesis<br>* Osteosynthesis with angle-stable plate followed by physiotherapy and self-training<br>|
| Experimental: Non-surgical<br> | Procedure: Non-surgical management<br>* Non-surgical management (physiotherapy and self-training)<br>|
| Experimental: Hemiarthroplasty<br> | Procedure: Hemiarthroplasty<br>* Primary modular hemiarthroplasty followed by physiotherapy and self-training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Disability Scale |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Shoulder Score, Short Form-36 |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus, Shoulder fractures