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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04248751
Eligibility Criteria:
Inclusion Criteria:
* Magnetic resonance imaging (MRI) proven diagnosis of a large \>3cm tear of the shoulder rotator cuff in a competent adult (\>18 years of age).
Exclusion Criteria:
* Patients with subscapular tear
* Glenohumeral osteoarthritis
* A normalized WORC score \>70 (where scores range between 0-100, and 100 is the best outcome)
* Uncontrolled diabetes (Hgb A1C \>7%)
* Pregnancy
* Presence of local or systemic infection
* Inability to cooperate with and/or comprehend post-operative instructions
* Nonvascular surgical sites (MRI proven)
* Poor nutritional state (Alb \<30 g/L)
* Cancer
* Paralysis of the shoulder
* Contracture of the shoulder
* Presence of cuff tear arthropathy or osteoarthritis of the shoulder
* Patients unable to provide informed consent for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04248751
Study Brief:
Protocol Section:
NCT04248751