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ACTIVE NOT RECRUITING
NCT07853950
NA

Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair

Sponsor: Ataturk University

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Efficacy of Autologous Fibrin Clot Applied to the Repair Interface in Arthroscopic Treatment of Rotator Cuff Tears: A Prospective, Randomized, Double-Blind Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-15

Completion Date

2027-02-28

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

PROCEDURE

Arthroscopic Rotator Cuff Repair

Standard arthroscopic repair of the torn rotator cuff tendon to its footprint using suture anchors.

BIOLOGICAL

Autologous Fibrin Clot

40 mL of venous blood is drawn from the patient during surgery and stirred with a sterile glass rod until a fibrin clot forms, without centrifugation. The clot is delivered arthroscopically to the tendon-bone repair interface.

Locations (1)

Ataturk University Education and Research Hospital

Erzurum, Erzurum, Turkey (Türkiye)