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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT06513559
Eligibility Criteria:
Inclusion Criteria:
* Primary glenohumeral arthritis,
* Intact rotator cuff,
* No important glenoid bone loss (cf exclusion criteria),
* Patients between 60 and 85 years old (based on indications for RTSA)
* Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
* B2 glenoid with \> 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
* B3 and C type glenoids,
* Full thickness rotator cuff tear,
* Acute or malunited proximal humeral fracture,
* Chronic locked dislocation
* Rheumatoid arthritis,
* Revision surgery or surgical antecedents,
* Tumors,
* Axillary nerve damage,
* Non-functioning deltoid muscle,
* Glenoid vault deficiency precluding baseplate fixation,
* Infection and neuropathic joints,
* Known or suspected non-compliance, drug or alcohol abuse,
* Patients incapable of judgement or under tutelage,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT06513559
Study Brief:
Protocol Section:
NCT06513559