- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835562
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Stig Brorson, MD, PhD
- Email: sbrorson@hotmail.com
Study Contact Backup
- Name: Asbjørn Hrobjartsson, MD, PhD
- Email: ah@cochrane.dk
Study Locations
-
-
-
Herlev, Denmark, DK-2730
- Recruiting
- Herlev University Hospital, Department Orthopaedic Surgery
-
Contact:
- Stig Brorson, MD, PhD
- Email: sbrorson@hotmail.com
-
Contact:
- Asbjørn Hrobjartsson, MD, PhD
- Email: ah@cochrane.dk
-
Principal Investigator:
- Stig Brorson, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Osteosynthesis
|
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
|
EXPERIMENTAL: Non-surgical
|
Non-surgical management (physiotherapy and self-training)
|
EXPERIMENTAL: Hemiarthroplasty
|
Primary modular hemiarthroplasty followed by physiotherapy and self-training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Constant Disability Scale
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxford Shoulder Score, Short Form-36
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shoulderfractures.RCT
- H-C-2008-065
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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