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

Herlev Hospital

Status and phase: Unknown; Phase 3

Conditions: Proximal Humeral Fractures

Treatments: Procedure: Osteosynthesis; Procedure: Hemiarthroplasty; Procedure: Non-surgical management

Study type: Interventional

Funder types: Other

Identifiers

NCT00835562

Shoulderfractures.RCT

H-C-2008-065

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 3 patient groups

Osteosynthesis

Experimental group

Treatment:

Procedure: Osteosynthesis

Non-surgical

Experimental group

Treatment:

Procedure: Non-surgical management

Hemiarthroplasty

Experimental group

Treatment:

Procedure: Hemiarthroplasty