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

May 17, 2026 updated by: Andriani Zafeiri, National and Kapodistrian University of Athens

ΕΝΙΣΧΥΣΗ ΑΡΘΡΟΣΚΟΠΙΚΗΣ ΣΥΡΡΑΦΗΣ ΣΤΡΟΦΙΚΟΥ ΠΕΤΑΛΟΥ ΜΕ ΕΠΑΝΕΜΦΥΤΕΥΣΗ ΙΣΤΟΥ ΤΟΥ ΥΠΑΚΡΩΜΙΑΚΟΥ ΘΥΛΑΚΟΥ ΚΑΙ ΠΛΑΣΜΑΤΟΣ ΠΛΟΥΣΙΟΥ ΣΕ ΑΙΜΟΠΕΤΑΛΙΑ

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Adult patients aged ≥18 years. Patients undergoing arthroscopic rotator cuff repair. Patients with a full-thickness, isolated, primary tear of the supraspinatus tendon.

Patients considered eligible for arthroscopic rotator cuff repair using suture anchors.

Ability and willingness to provide written informed consent. Willingness and ability to comply with the study protocol and scheduled follow-up visits.

Exclusion Criteria Partial-thickness rotator cuff tears. Massive or irreparable rotator cuff tears. Revision rotator cuff repair. Concomitant tears of the subscapularis tendon, infraspinatus tendon, long head of the biceps tendon requiring surgical treatment, or glenoid labrum.

Previous surgery on the affected shoulder. Glenohumeral osteoarthritis or advanced cuff tear arthropathy. Active infection or systemic inflammatory disease affecting the shoulder. Use of other biological augmentation techniques during surgery, such as collagen patch, stem cells, bone marrow aspirate concentrate, or other scaffold-based augmentation.

Inability to provide informed consent. Inability or unwillingness to comply with the postoperative rehabilitation protocol or follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A
(MSCs + PRP): 1 ml of a mixture of subacromial bursa and 3 ml of PRP will be placed in the bone-tendon junction after completion of the arthroscopic suturing
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.
Experimental: GROUP B
1 ml of a mixture of subacromial bursal tissue fragments without PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
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.
Experimental: GROUP C
3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic 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.
Placebo Comparator: GROUP D
3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
Procedure: Arthroscopic Rotator Cuff Repair
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcome Assessed by Constant-Murley Score and ASES Score
Time Frame: The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments evaluating pain, daily activities, and shoulder function, with higher scores indicating better clinical outcomes.
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification)
Time Frame: 12 months postoperatively
Tendon integrity will be evaluated using magnetic resonance imaging (MRI) at 12 months postoperatively. Repair integrity will be classified according to the Sugaya classification system and categorized to assess healing or re-tear.
12 months postoperatively
Pain Intensity Assessed by Numeric Rating Scale (NRS)
Time Frame: 3, 6, and 12 months postoperatively
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 3, 6, and 12 months postoperatively.
3, 6, and 12 months postoperatively
Health-Related Quality of Life Assessed by SF-12
Time Frame: 3, 6, and 12 months postoperatively
Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12) at 3, 6, and 12 months postoperatively. The questionnaire provides physical and mental health composite scores.
3, 6, and 12 months postoperatively
Patient Satisfaction
Time Frame: 3, 6, and 12 months postoperatively
Patient satisfaction will be assessed using a Numeric Rating Scale from 0 to 10 at 3, 6, and 12 months postoperatively, with higher scores indicating greater satisfaction.
3, 6, and 12 months postoperatively
Postoperative Complications and Retear Rate
Time Frame: Up to 12 months postoperatively
All postoperative complications and symptomatic retears will be recorded throughout the follow-up period.
Up to 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Collaborators

Athens Medical Center

Investigators

  • Principal Investigator: Andriani Zafeiri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

May 9, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12518/03.02.2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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