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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Herlev Hospital.
Recruitment status was:  Recruiting
Aalborg Universitetshospital
Zealand University Hospital
Odense University Hospital
Information provided by (Responsible Party):
Stig Brorson, Herlev Hospital Identifier:
First received: February 2, 2009
Last updated: June 6, 2012
Last verified: June 2012

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.

Condition Intervention Phase
Proximal Humeral Fractures
Procedure: Non-surgical management
Procedure: Osteosynthesis
Procedure: Hemiarthroplasty
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

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

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

Estimated Enrollment: 162
Study Start Date: April 2009
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteosynthesis Procedure: Osteosynthesis
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
Experimental: Non-surgical Procedure: Non-surgical management
Non-surgical management (physiotherapy and self-training)
Experimental: Hemiarthroplasty Procedure: Hemiarthroplasty
Primary modular hemiarthroplasty followed by physiotherapy and self-training


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00835562

Contact: Stig Brorson, MD, PhD
Contact: Asbjørn Hrobjartsson, MD, PhD

Herlev University Hospital, Department Orthopaedic Surgery Recruiting
Herlev, Denmark, DK-2730
Contact: Stig Brorson, MD, PhD   
Contact: Asbjørn Hrobjartsson, MD, PhD   
Principal Investigator: Stig Brorson, MD, PhD         
Sponsors and Collaborators
Herlev Hospital
Aalborg Universitetshospital
Zealand University Hospital
Odense University Hospital
  More Information

Responsible Party: Stig Brorson, MD PhD, Herlev Hospital Identifier: NCT00835562     History of Changes
Other Study ID Numbers: Shoulderfractures.RCT
Study First Received: February 2, 2009
Last Updated: June 6, 2012

Keywords provided by Herlev Hospital:
Shoulder fractures
Proximal humeral fractures
Randomised clinical trial
Displaced four-part fractures of the proximal humerus

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries processed this record on May 25, 2017