Cuff Injury, RotatorNCT07589478
Augmentation of Arthroscopic Rotator Cuff Repair With Reimplantation of Subacromial Bursa Tissue and Platelet-Rich Plasma
A study testing Subacromial Bursa Tissue Reimplantation, Arthroscopic Rotator Cuff Repair and Platelet-Rich Plasma (PRP) Injections in people with Cuff Injury, Rotator and Arthroscopic Surgical Procedures, run by National and Kapodistrian University of Athens.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cuff Injury, Rotator, Arthroscopic Surgical Procedures, Stem Cell
- What is being tested?
- Subacromial Bursa Tissue Reimplantation, Arthroscopic Rotator Cuff Repair and Platelet-Rich Plasma (PRP) Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Cuff Injury, Rotator, Arthroscopic Surgical Procedures, Stem Cell, PRP
- Being tested
- Subacromial Bursa Tissue Reimplantation, Arthroscopic Rotator Cuff Repair, Platelet-Rich Plasma (PRP) Injections, Normal Saline (0.9% NaCl)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacromial Bursa Tissue ReimplantationBiological
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 RepairProcedure or surgery
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Platelet-Rich Plasma (PRP) InjectionsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Subacromial Bursa Tissue Reimplantation; Procedure: Arthroscopic Rotator Cuff Repair; Biological: Platelet-Rich Plasma (PRP) Injections |
| GROUP B | Experimental | 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. Receives: Biological: Subacromial Bursa Tissue Reimplantation; Procedure: Arthroscopic Rotator Cuff Repair |
| GROUP C | Experimental | 3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair. Receives: Procedure: Arthroscopic Rotator Cuff Repair; Biological: Platelet-Rich Plasma (PRP) Injections |
| GROUP D | Placebo comparator | 3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair. Receives: Procedure: Arthroscopic Rotator Cuff Repair; Other: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 12 months postoperatively
Pain Intensity Assessed by Numeric Rating Scale (NRS)
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.
Measured: 3, 6, and 12 months postoperatively
Health-Related Quality of Life Assessed by SF-12
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.
Measured: 3, 6, and 12 months postoperatively
Patient Satisfaction
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.
Measured: 3, 6, and 12 months postoperatively
Postoperative Complications and Retear Rate
All postoperative complications and symptomatic retears will be recorded throughout the follow-up period.
Measured: Up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Injury, RotatorStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Athens Medical Center
- Responsible party
- Principal investigator, Andriani Zafeiri, National and Kapodistrian University of Athens
- Investigators
- Andriani Zafeiri, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589478
- Sponsor's protocol ID
- 12518/03.02.2026
- Status last verified
- May 2026
- First submitted
- 23 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ΕΝΙΣΧΥΣΗ ΑΡΘΡΟΣΚΟΠΙΚΗΣ ΣΥΡΡΑΦΗΣ ΣΤΡΟΦΙΚΟΥ ΠΕΤΑΛΟΥ ΜΕ ΕΠΑΝΕΜΦΥΤΕΥΣΗ ΙΣΤΟΥ ΤΟΥ ΥΠΑΚΡΩΜΙΑΚΟΥ ΘΥΛΑΚΟΥ ΚΑΙ ΠΛΑΣΜΑΤΟΣ ΠΛΟΥΣΙΟΥ ΣΕ ΑΙΜΟΠΕΤΑΛΙΑ
- ClinicalTrials.gov ID
- NCT07589478
- Acronym / sponsor ID
- 12518/03.02.2026
- Conditions
- Cuff Injury, Rotator, Arthroscopic Surgical Procedures, Stem Cell, PRP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Athens Medical Center
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Biological: Subacromial Bursa Tissue Reimplantation, Procedure: Arthroscopic Rotator Cuff Repair, Biological: Platelet-Rich Plasma (PRP) Injections(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 | Experimental | Biological: Subacromial Bursa Tissue Reimplantation, Procedure: Arthroscopic Rotator Cuff Repair1 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 | Experimental | Procedure: Arthroscopic Rotator Cuff Repair, Biological: Platelet-Rich Plasma (PRP) Injections3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair. |
| GROUP D | Placebo comparator | Procedure: Arthroscopic Rotator Cuff Repair, Other: Normal Saline (0.9% NaCl)3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subacromial Bursa Tissue ReimplantationAutologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair. | Biological | GROUP A, GROUP B |
| Arthroscopic Rotator Cuff RepairStandard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors. | Procedure or surgery | GROUP A, GROUP B, GROUP C, GROUP D |
| Platelet-Rich Plasma (PRP) InjectionsAutologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion. | Biological | GROUP A, GROUP C |
| 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. | Other | GROUP D |
Primary outcome
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.
5 secondary outcomes
Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification)
Time frame: 12 months postoperatively
Pain Intensity Assessed by Numeric Rating Scale (NRS)
Time frame: 3, 6, and 12 months postoperatively
Health-Related Quality of Life Assessed by SF-12
Time frame: 3, 6, and 12 months postoperatively
Patient Satisfaction
Time frame: 3, 6, and 12 months postoperatively
Postoperative Complications and Retear Rate
Time frame: Up to 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andriani Zafeiri principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Subacromial Bursa Tissue Reimplantation, Arthroscopic Rotator Cuff Repair and Platelet-Rich Plasma (PRP) Injections in people with Cuff Injury, Rotator and Arthroscopic Surgical Procedures, run by National and Kapodistrian University of Athens.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ANDRIANI ZAFEIRI, MEDICAL DOCTOR (+306933398382, andrianizaf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.