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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Herlev Hospital

Current Primary Outcome: Constant Disability Scale [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Oxford Shoulder Score, Short Form-36 [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Herlev Hospital

Dates:
Date Received: February 2, 2009
Date Started: April 2009
Date Completion:
Last Updated: June 6, 2012
Last Verified: June 2012