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:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT05351112
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years or older and skeletally mature
* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
* Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
1. Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
2. Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
3. Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
4. Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
5. Posttraumatic necrosis of the humeral head
6. Posttraumatic arthrosis after humeral head fracture
Exclusion Criteria:
* Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
* The patient is known to be pregnant or breastfeeding
* Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
* Patients with plans to relocate during the study follow-up period
* Signs of infection
* Extensive stiffening of the shoulder joint without pain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05351112
Study Brief:
Protocol Section:
NCT05351112