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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT03431857
Eligibility Criteria:
Inclusion Criteria:
* Except in special cases, the "anatomic" type is indicated for:
* Centered osteoarthritis of the shoulder
* Humeral head fractures
* Rheumatoid arthritis (with intact rotator cuff)
* Avascular necrosis of the humeral head
* Except in special cases, the "reversed" type is indicated for:
* Offset osteoarthritis of the shoulder
* Massive and non-repairable rotator cuff tears
* Rheumatoid arthritis (with degenerative rotator cuff)
* Revision in cases of:
* Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
* Conversion of a hemi-arthroplasty into a total arthroplasty
* Increasing the size of the stem (length and/or diameter)
* Replacing a glenoid prosthesis
* Replacing a competitor's prosthesis
* In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis
* Additional inclusion criteria include
* Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
* Willing to return for follow-up evaluations
Exclusion Criteria:
* Local or systemic infections.
* Severe muscular, neurological, or vascular deficiency of the affected joint.
* Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
* Any concomitant complaint likely to affect the functioning of the implant.
* Allergy to any of the implant components.
* Local bone tumors.
* Patient over 18 under law supervision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03431857
Study Brief:
Protocol Section:
NCT03431857