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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05959733
Eligibility Criteria:
Inclusion Criteria:
* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
* over 18 years of age
Exclusion Criteria:
* glenohumeral osteoarthritis
* Western Ontario rotator cuff score \>60
* uncontrolled diabetes (Hgb A1C \>7%)
* pregnant
* local or systemic infection
* inability to cooperate with and/or comprehend post-operative instructions
* MRI proven non-vascular sites
* poor nutritional state (Alb \<30 g/L)
* cancer
* paralysis of the shoulder
* contracture of the shoulder
* patients unable to provide informed consent for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05959733
Study Brief:
Protocol Section:
NCT05959733