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Active Not Recruiting NCT07853950

Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair

Conditions: Rotator Cuff Tears, Rotator Cuff Injuries

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Ataturk University

Location: Ataturk University Education and Research Hospital Erzurum Erzurum

Summary

The aim of this study is to evaluate whether applying an autologous fibrin clot to the repair site improves tendon healing and clinical outcomes after arthroscopic rotator cuff repair. Fifty patients with rotator cuff tears requiring surgery were randomly assigned to two groups: arthroscopic repair with autologous fibrin clot augmentation or standard arthroscopic repair alone. The fibrin clot is prepared from the patient's own blood without centrifugation. Tendon healing is assessed with magnetic resonance imaging (MRI) using the Sugaya classification at 12 months, and shoulder function and pain are assessed with the ASES score, Constant score and Visual Analog Scale (VAS) preoperatively and at 3, 6 and 12 months.

Eligibility Criteria

Inclusion Criteria: * Age between 18 and 80 years * Full-thickness or partial-thickness rotator cuff tear with an indication for arthroscopic surgical repair * Goutallier fatty infiltration grade 1 or 2 * Written informed consent Exclusion Criteria: * Massive rotator cuff tear * Advanced glenohumeral osteoarthritis * Previous open shoulder surgery * Serious comorbid disease (e.g., uncontrolled diabetes mellitus, advanced rheumatoid arthritis)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07853950). StuddyBuddy aggregates publicly available trial information.