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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT04588506
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
* Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).
* Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2
* Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)
Exclusion Criteria:
* Subjects having severe glenohumeral arthritis
* History of prior tendon transfer
* Axillary nerve injury
* Deltoid deficiency
* Subjects with pseudo paralysis
* History of post-operative deep shoulder infection
* Non-English-speaking subjects.
* Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study
* Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04588506
Study Brief:
Protocol Section:
NCT04588506