Status:
TERMINATED
Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Helsinki University Central Hospital
Finnish Institute for Health and Welfare
Conditions:
Humeral Fracture
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not be...
Eligibility Criteria
Inclusion
- Age 65 years and older
- Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.
- 3- or 4-part fracture with \>5mm dislocation of the anatomic neck.
- AO classification C1-2 for non-luxation fractures
- AO classification C3 for luxation fractures
Exclusion
- Head Splitting fracture
- Open fracture
- Additional fractures in the shoulder region
- Other injuries requiring surgical treatment
- Clinically significant injury of the brachial plexus or vasculature
- Pathological fracture associated with cancer
- History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
- Rheumatoid Arthritis in the shoulder requiring active treatment
- Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
- unwillingness to accept some of the treatment options.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00999193
Start Date
November 1 2010
End Date
February 22 2024
Last Update
January 7 2025
Active Locations (1)
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1
Töölö Hospital Trauma Center, Helsinki University Central Hospital,
Helsinki, Finland