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NCT Number: NCT07589478

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

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.

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Key information

Conditions

Cuff Injury, Rotator Arthroscopic Surgical Procedures PRP Rotator Cuff Injuries Rupture Shoulder Injuries Stem Cell Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subacromial Bursa Tissue Reimplantation

Biological

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

Arthroscopic Rotator Cuff Repair

Procedure

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

Platelet-Rich Plasma (PRP) Injections

Biological

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

Normal Saline (0.9% NaCl)

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ANDRIANI ZAFEIRI, MEDICAL DOCTOR

CONTACT

[email protected]

+306933398382

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Athens Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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