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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 June 27, 2025

Enrolling by invitation

Keywords

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

ClinConnect Summary

This prospective observational study is designed to evaluate tendon healing and functional outcomes following surgical repair of massive rotator cuff tears. The study will be conducted at the Department of Orthopaedics and Traumatology, Gazi University Hospital. Patients aged between 18 and 80 years, diagnosed with massive rotator cuff tears on preoperative MRI and scheduled for surgical intervention, will be included.

Massive tears are defined as full-thickness tears involving two or more rotator cuff tendons and/or showing retraction to the level of the glenoid. Exclusion criteria includ...

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