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 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT05981833
Eligibility Criteria:
Inclusion Criteria:
* The subject is between the ages of 30 and 75 years.
* Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
* Two complete RCTs or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension
* Primary rotator cuff repair
* Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative MRI6. Subject has a dual x-ray absorptiometry (DXA) or anterior posterior x-ray view of the target shoulder
Exclusion Criteria:
* The Subject is unable or unwilling to sign the patient informed consent, approved by the Institutional Review Board.
* The subject objects to the use of allograft
* Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle
* Complete full-thickness subscapularis tears of greater than the superior one third of the tendon (Lafosse grade 3 and above)
* Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
* Recurrent shoulder instability
* Corticosteroid injection in the operative shoulder within one month of surgery
* Revision rotator cuff repair
* Subject preoperative MRI obtained more than 12 months prior to surgery
* Pregnant or planning to become pregnant during the study period
* Workman's compensation case
* Subject has conditions or circumstances that would interfere with study requirements.
Intraoperative exclusion criteria:
Partial rotator cuff repairs
Lafosse grade 3 or higher subscapularis tears
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05981833
Study Brief:
Protocol Section:
NCT05981833