Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair

NCT07853950 | Active Not Recruiting

• 2 other identifiers: ATAUNI-KAEK-2025-102025-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries

Keywords

Rotator Cuff Repair; Fibrin Clot; Autologous Fibrin; Arthroscopy; Biological Augmentation; Tendon Healing; Retear; Sugaya Classification

Outcome Measures

Primary Outcomes (1)

• Rotator Cuff Repair Integrity on MRI (Sugaya Classification)

  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.

  12 months postoperatively

Secondary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Score

  Preoperatively and at 3, 6 and 12 months postoperatively

Other Outcomes (2)

• Constant-Murley Score

  Preoperatively and at 3, 6 and 12 months postoperatively

• Visual Analog Scale (VAS) for Pain

  Preoperatively and at 3, 6 and 12 months postoperatively

Study Arms (2)

Fibrin Clot Group

EXPERIMENTAL

Arthroscopic rotator cuff repair augmented with an autologous fibrin clot applied to the tendon-bone repair interface.

Procedure: Arthroscopic Rotator Cuff Repair; Biological: Autologous Fibrin Clot

Control Group

ACTIVE COMPARATOR

Standard arthroscopic rotator cuff repair without fibrin clot augmentation.

Procedure: Arthroscopic Rotator Cuff Repair

Interventions

Arthroscopic Rotator Cuff Repair PROCEDURE

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

Control Group; Fibrin Clot Group

Autologous Fibrin Clot BIOLOGICAL

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.

Also known as: Endogenous Fibrin Clot

Fibrin Clot Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Massive rotator cuff tear
• Advanced glenohumeral osteoarthritis
• Previous open shoulder surgery
• Serious comorbid disease (e.g., uncontrolled diabetes mellitus, advanced rheumatoid arthritis)

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Education and Research Hospital

Erzurum, Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.

  PMID: 22495146 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and the outcome assessors evaluating MRI and clinical scores are blinded to group allocation. The operating surgeon cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmet Emre Paksoy,Associate Professor, Department of Orthopaedics and Traumatology

Model Details: Patients were randomized in a 1:1 ratio to either arthroscopic rotator cuff repair with autologous fibrin clot augmentation or standard arthroscopic rotator cuff repair.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)