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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02424760
Eligibility Criteria:
Inclusion Criteria:
* patients requiring a Humeral Head Replacement (HHR) with INSPYRE as per indication of the Instruction For Use:
* with degenerative indication such as primary Gleno Humeral (GH) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
* presenting a functional rotator cuff,
* able to return for all scheduled and required study visit;
* having provided informed Consent about scientific study participation if applicable.
Exclusion Criteria:
* Acute proximal humeral fracture,
* Systemic or local infection,
* Rotator cuff tear,
* Instability of the humeral head,
* Axillary nerve palsy,
* Revision arthroplasty.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02424760
Study Brief:
Protocol Section:
NCT02424760