Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair

Condition(s) studied

Investigational drug(s) / intervention(s)

Arthroscopic Rotator Cuff Repair: Standard arthroscopic repair of the torn rotator cuff tendon to its footprint using suture anchors.

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.

Study 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

Primary outcome measure(s)

• Rotator Cuff Repair Integrity on MRI (Sugaya Classification) — 12 months postoperatively
  Repair integrity is evaluated with magnetic resonance imaging and classified according to the Sugaya classification (Type I to V). Types I-III are considered healed and Types IV-V are considered retear. The proportion of healed repairs and the retear rate are compared between groups.

Trial sites (1)

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