Trial record 4 of 14 for:    Open Studies | "Shoulder Fractures"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Herlev Hospital.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014