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

Phase 3

• Conditions: Proximal Humeral Fractures
• Interventions: Procedure: Non-surgical management; Procedure: Hemiarthroplasty; Procedure: Osteosynthesis

• Registration Number: NCT00835562
• Lead Sponsor: Herlev Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Study Start: 2009-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-surgical	Non-surgical management	-
Hemiarthroplasty	Hemiarthroplasty	-
Osteosynthesis	Osteosynthesis	-

Primary Outcome Measures

Name	Time	Method
Constant Disability Scale	3 years

Secondary Outcome Measures

Name	Time	Method
Oxford Shoulder Score, Short Form-36	3 years

Trial Locations

Locations (1)

Herlev University Hospital, Department Orthopaedic Surgery; 🇩🇰 Herlev, Denmark