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Clinical Trials/NCT00835562
NCT00835562
Unknown
Phase 3

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

Herlev Hospital1 site in 1 country162 target enrollmentApril 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Proximal Humeral Fractures
Sponsor
Herlev Hospital
Enrollment
162
Locations
1
Primary Endpoint
Constant Disability Scale
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
March 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stig Brorson

MD PhD

Herlev Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Constant Disability Scale

Time Frame: 3 years

Secondary Outcomes

  • Oxford Shoulder Score, Short Form-36(3 years)

Study Sites (1)

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