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Clinical Trials/NCT00835562
NCT00835562UnknownPhase 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 enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Enrollment
162
Locations
1
Primary Endpoint
Constant Disability Scale

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hemiarthroplasty

Experimental

Intervention: Hemiarthroplasty (Procedure)

Osteosynthesis

Experimental

Intervention: Osteosynthesis (Procedure)

Non-surgical

Experimental

Intervention: Non-surgical management (Procedure)

Outcomes

Primary Outcomes

Constant Disability Scale

Time Frame: 3 years

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stig Brorson

MD PhD

Herlev Hospital

Study Sites (1)

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