Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
Primary Purpose
Proximal Humeral Fractures
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Non-surgical management
Osteosynthesis
Hemiarthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Humeral Fractures focused on measuring Shoulder fractures, Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus
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
Sites / Locations
- Herlev University Hospital, Department Orthopaedic SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Osteosynthesis
Non-surgical
Hemiarthroplasty
Arm Description
Outcomes
Primary Outcome Measures
Constant Disability Scale
Secondary Outcome Measures
Oxford Shoulder Score, Short Form-36
Full Information
NCT ID
NCT00835562
First Posted
February 2, 2009
Last Updated
June 6, 2012
Sponsor
Herlev Hospital
Collaborators
Aalborg University Hospital, Zealand University Hospital, Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00835562
Brief Title
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Aalborg University Hospital, Zealand University Hospital, Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fractures
Keywords
Shoulder fractures, Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteosynthesis
Arm Type
Experimental
Arm Title
Non-surgical
Arm Type
Experimental
Arm Title
Hemiarthroplasty
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Non-surgical management
Intervention Description
Non-surgical management (physiotherapy and self-training)
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis
Intervention Description
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
Intervention Type
Procedure
Intervention Name(s)
Hemiarthroplasty
Intervention Description
Primary modular hemiarthroplasty followed by physiotherapy and self-training
Primary Outcome Measure Information:
Title
Constant Disability Scale
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Oxford Shoulder Score, Short Form-36
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stig Brorson, MD, PhD
Email
sbrorson@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asbjørn Hrobjartsson, MD, PhD
Email
ah@cochrane.dk
Facility Information:
Facility Name
Herlev University Hospital, Department Orthopaedic Surgery
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stig Brorson, MD, PhD
Email
sbrorson@hotmail.com
First Name & Middle Initial & Last Name & Degree
Asbjørn Hrobjartsson, MD, PhD
Email
ah@cochrane.dk
First Name & Middle Initial & Last Name & Degree
Stig Brorson, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived
Learn more about this trial
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
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