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:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT01288066
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)
* Glenoid morphologic type A1, A2 or B1 according to Walch
* Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
* Written informed consent
Exclusion Criteria:
Preoperative:
* Posttraumatic omarthrosis
* Biconcave aspect of glenoid (Walch type B2)
* Retroversion of glenoid more than 25° (Walch type C)
* "Epoca Reko" prosthesis
* Humerus fractures
* Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)
* Substance abuse that would preclude reliable assessment
* Pregnancy
* Prisoners
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Intraoperative:
* Full thickness tear of rotator cuff
* Indication for hemiarthroplasty only
* Indication for total arthroplasty only
* Intraoperative decision to use implants other than Epoca
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01288066
Study Brief:
Protocol Section:
NCT01288066