Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT00999193
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00999193
Study Brief:
Protocol Section:
NCT00999193