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Search / Trial NCT07004218

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

Launched by GAZI UNIVERSITY · May 27, 2025

Trial Information

Current as of September 12, 2025

Enrolling by invitation

Keywords

Massive Rotator Cuff Tear Rotator Cuff Repair Retear Postoperative Follow Up Tendon Survivability

ClinConnect Summary

This is a prospective, observational study being done at Gazi University Hospital in Ankara, Turkey. It will follow about 40 adults with a large rotator cuff tear who are planned to have surgical repair, to see how well the repaired tendon heals and how that healing relates to shoulder function and pain over 12 months. The main question is how often the tendon tears again after surgery (retear) by 12 months, and whether healing seen on ultrasound matches better function and less pain. Ulstrasonography (an ultrasound scan) and standard shoulder scores (ASES, UCLA, and a pain scale) will be checked at about 2 weeks, 3 months, 6 months, and 12 months after surgery. Results aren’t available yet.

Who can take part? Adults aged 18 to 80 with a preoperative MRI showing a massive rotator cuff tear (involvement of two or more tendons or tears that retract to the shoulder socket) and who are scheduled for repair, with no previous shoulder surgery on the affected side, and who can commit to follow-up visits. People with tears that are irreparable during surgery, advanced shoulder arthritis, certain neurological or inflammatory conditions, active infection, or any reason they likely can’t complete return visits are not eligible. If you qualify, you’ll have imaging and clinic visits over about a year to help doctors understand which factors predict tendon healing and better recovery. The study does not involve a drug or new device.

Gender

ALL

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

About Gazi University

Gazi University, a leading research institution based in Ankara, Turkey, is committed to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university integrates cutting-edge research with clinical practice to explore new therapeutic approaches and enhance existing treatments. Gazi University adheres to the highest ethical standards and regulatory guidelines, ensuring the integrity and safety of its clinical trials. By fostering partnerships with healthcare professionals and academic institutions, Gazi University aims to contribute significantly to the global scientific community and address pressing health challenges.

Locations

çankaya, Ankara, Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported