Augmentation of Arthroscopic Rotator Cuff Repair With Reimplantation of Subacromial Bursa Tissue and Platelet-Rich Plasma
ΕΝΙΣΧΥΣΗ ΑΡΘΡΟΣΚΟΠΙΚΗΣ ΣΥΡΡΑΦΗΣ ΣΤΡΟΦΙΚΟΥ ΠΕΤΑΛΟΥ ΜΕ ΕΠΑΝΕΜΦΥΤΕΥΣΗ ΙΣΤΟΥ ΤΟΥ ΥΠΑΚΡΩΜΙΑΚΟΥ ΘΥΛΑΚΟΥ ΚΑΙ ΠΛΑΣΜΑΤΟΣ ΠΛΟΥΣΙΟΥ ΣΕ ΑΙΜΟΠΕΤΑΛΙΑ
1 other identifier
interventional
200
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
May 19, 2026
May 1, 2026
8 months
March 23, 2026
May 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Functional Outcome Assessed by Constant-Murley Score and ASES Score
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 Outcomes (5)
Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification)
12 months postoperatively
Pain Intensity Assessed by Numeric Rating Scale (NRS)
3, 6, and 12 months postoperatively
Health-Related Quality of Life Assessed by SF-12
3, 6, and 12 months postoperatively
Patient Satisfaction
3, 6, and 12 months postoperatively
Postoperative Complications and Retear Rate
Up to 12 months postoperatively
Study Arms (4)
GROUP A
EXPERIMENTAL(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
GROUP B
EXPERIMENTAL1 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.
GROUP C
EXPERIMENTAL3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
GROUP D
PLACEBO COMPARATOR3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
Interventions
Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
Three milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andriani Zafeiri
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MEDICAL DOCTOR
Study Record Dates
First Submitted
March 23, 2026
First Posted
May 15, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05