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Augmentation of Arthroscopic Rotator Cuff Repair With Reimplantation of Subacromial Bursa Tissue and Platelet-Rich Plasma

NCT07589478 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-19

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the clinical and radiographic outcomes of the biological enhancement of the arthroscopic rotator cuff repair with stem cells from the acromial bursa and PRP in individuals who undergo arthroscopic cuff repair The main question it aims to answer is:

Do the stems cells from the acromial bursa and PRP promote healing and produce better results in arthroscopic cuff repair? Researchers will compare this population to three others the first do bnot receive any biological enchancement, the second receive only stem cells and the third receive only PRP to see if there are any differences.

Conditions

  • Cuff Injury, Rotator
  • Arthroscopic Surgical Procedures
  • Stem Cell
  • PRP

Interventions

BIOLOGICAL

Subacromial Bursa Tissue Reimplantation

Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.

PROCEDURE

Arthroscopic Rotator Cuff Repair

Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.

BIOLOGICAL

Platelet-Rich Plasma (PRP) Injections

Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.

OTHER

Normal Saline (0.9% NaCl)

Three milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.

Sponsors & Collaborators

  • Athens Medical Center

    collaborator OTHER

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Andriani Zafeiri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-01-31
Completion
2028-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07589478 on ClinicalTrials.gov