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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT07004218
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a massive rotator cuff tear confirmed by preoperative magnetic resonance imaging (MRI), involving at least two tendons and/or retraction to the glenoid level.
Scheduled for surgical rotator cuff repair at Gazi University Hospital, Department of Orthopaedics and Traumatology.
Ability and willingness to undergo postoperative follow-up and imaging (ultrasound) at 2 weeks, 3 months, 6 months, and 12 months post-surgery.
Ability to provide written informed consent.
No prior surgery on the affected shoulder.
Adequate cognitive and physical capacity to comply with postoperative rehabilitation protocols and outcome assessments.
Exclusion Criteria:
* Previous surgical intervention on the affected shoulder (including rotator cuff repair, shoulder arthroplasty, or arthroscopy).
Irreparable rotator cuff tears determined intraoperatively (e.g., excessive retraction, poor tissue quality).
Presence of advanced glenohumeral osteoarthritis (e.g., Hamada grade ≥ 3).
Neurological disorders affecting shoulder function (e.g., brachial plexopathy, stroke-related hemiparesis).
Systemic inflammatory or rheumatologic diseases (e.g., rheumatoid arthritis, lupus) affecting musculoskeletal function.
Infectious conditions of the shoulder or systemic infection at the time of surgery.
Inability to attend regular follow-ups or comply with the rehabilitation protocol due to psychiatric illness, cognitive impairment, or other medical conditions.
Refusal or inability to provide informed consent.
Poor general health status contraindicating surgery or anesthesia (e.g., ASA IV or higher
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07004218
Study Brief:
Protocol Section:
NCT07004218