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

This study is currently recruiting participants.
Verified June 2012 by Herlev Hospital
Sponsor:
Collaborators:
Aalborg Universityhospital
Koege Sygehus
Odense University Hospital
Information provided by (Responsible Party):
Stig Brorson, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00835562
First received: February 2, 2009
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxford Shoulder Score, Short Form-36 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835562

Contacts
Contact: Stig Brorson, MD, PhD sbrorson@hotmail.com
Contact: Asbjørn Hrobjartsson, MD, PhD ah@cochrane.dk

Locations
Denmark
Herlev University Hospital, Department Orthopaedic Surgery Recruiting
Herlev, Denmark, DK-2730
Contact: Stig Brorson, MD, PhD       sbrorson@hotmail.com   
Contact: Asbjørn Hrobjartsson, MD, PhD       ah@cochrane.dk   
Principal Investigator: Stig Brorson, MD, PhD         
Sponsors and Collaborators
Herlev Hospital
Aalborg Universityhospital
Koege Sygehus
Odense University Hospital
  More Information

No publications provided

Responsible Party: Stig Brorson, MD PhD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00835562     History of Changes
Other Study ID Numbers: Shoulderfractures.RCT, H-C-2008-065
Study First Received: February 2, 2009
Last Updated: June 6, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 22, 2014