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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02452957
Eligibility Criteria:
Inclusion Criteria:
* A subject must meet all of the following inclusion criteria in order to enter the study:
* Adult subject 18 years or older,
* Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
* Scapula and proximal humerus must have reached skeletal maturity,
* Willing and able to comply with the protocol,
* Willing and able to personally sign the informed consent form,
* Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.
Exclusion Criteria:
* A subject will not be eligible to participate in the study if any of the following conditions is present:
* lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
* Severe Walch grade B2 glenoid defined as \>60% posterior head displacement and \>20% posterior glenoid bone loss,
* metal allergies or sensitivity,
* infection at or near the site of implantation,
* distant or systemic infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02452957
Study Brief:
Protocol Section:
NCT02452957