Postoperative USG Control and Clinical Follow-up of Massive Rotator Cuff Tendon Ruptures

NCT07004218 · tracked via the Priya Life Science Turkey tracker

Sponsor

Gazi University

Phase

Observational

Started

2025-02-01

Last updated

2025-06-04

Condition(s) studied

Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff Tears

Study summary

This prospective observational study aims to investigate the tendon integrity and clinical outcomes following surgical repair of massive rotator cuff tears. Patients with preoperatively diagnosed massive tears, confirmed by MRI and scheduled for surgery, will be included. Tendon healing will be assessed using ultrasonography at postoperative 2 weeks, 3 months, 6 months, and 12 months. Clinical evaluation will be conducted using standardized scoring systems including ASES, UCLA Shoulder Score, VAS, and thresholds for MCID, SCB, and PASS.

The primary outcome is the rate and timing of retears at 12 months and their correlation with functional recovery. The study also aims to identify prognostic factors affecting tendon survivability, such as age, tear size, and muscle quality. By combining imaging and clinical parameters, this study seeks to contribute to the optimization of postoperative follow-up and rehabilitation strategies in the treatment of massive rotator cuff tears.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Primary outcome is tendon integrity at 12 months postoperatively, evaluated by ultrasonography, and its correlation with clinical outcomes including ASES, UCLA, VAS scores, and MCID. Retear presence and timing will also be recorded. — Ultrasonography and clinical evaluations will be conducted at 2 weeks, 3 months, 6 months, and 12 months postoperatively to assess tendon integrity and functional outcomes following rotator cuff repair.
This prospective observational study aims to evaluate early tendon healing and clinical outcomes following surgical repair of massive rotator cuff tears. Patients diagnosed preoperatively with massive rotator cuff tears via MRI and scheduled for surgery at Gazi University Hospital will be included. Tendon integrity will be assessed through ultrasonography at 2 weeks, 3 months, 6 months, and 12 months postoperatively. Clinical outcomes will be measured using ASES, UCLA Shoulder Score, and VAS, as well as MCID, SCB, and PASS thresholds. The correlation between anatomical healing and functional recovery will be investigated. Patients aged 18-80 years without prior shoulder surgery will be eligible. Exclusion criteria include irreparable tears, neurological disorders, and systemic inflammatory diseases. The primary endpoint is retear rate at 12 months. Data will be collected by orthopedic surgeons and radiologists. This study aims to identify prognostic indicators for tendon survivability

Trial sites (1)

Facility	City	Region	Status
Gazı University	Çankaya	Ankara

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07004218 on ClinicalTrials.gov ↗ ← All trials in Turkey