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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT07192302
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80 years.
2. Symptomatic shoulder pain for \>2 weeks.
3. MRI-confirmed partial-thickness rotator cuff tear (\>50% tendon thickness or \>5mm in length).
4. Concomitant shoulder stiffness, defined as passive range of motion loss of ≥25% in at least two planes (forward flexion, abduction, external rotation, or internal rotation) compared to the contralateral side.
5. Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs).
Exclusion Criteria:
1. Age\< 18 or \>80 years.
2. Full-thickness rotator cuff tear.
3. Previous surgery on the affected shoulder.
4. Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto).
5. Cervical radiculopathy as a primary cause of symptoms.
6. Systemic inflammatory arthritis.
7. Neurologic disorder affecting the shoulder.
8. Contraindications to surgery or general anesthesia.
9. Inability to comply with the rehabilitation protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07192302
Study Brief:
Protocol Section:
NCT07192302