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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT04965103
Eligibility Criteria:
Inclusion Criteria:
1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
2. Either primary tear or re-tear after previous repair
3. Radiographic evidence of Hamada stage 1-3, with or without Samilson \& Prieto mild osteoarthritis (\<3mm inferior osteophyte)
Exclusion Criteria:
1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson \& Prieto classification moderate or greater
2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
4. Medical issues precluding surgery
5. Unwilling or unable to complete study outcomes
6. Worker's Compensation Claim or litigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04965103
Study Brief:
Protocol Section:
NCT04965103