Rotator Cuff TearPhase 2NCT07689383
The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study
A Phase 2 study testing Arthroscopic repair of shoulder rotator cuff tear and PRP injection in people with Rotator Cuff Tear and Rotator Cuff Repair of the Shoulder, run by KAT General Hospital at 1 site in Greece.
Trial summary
Purpose of the study: The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Repair of the Shoulder, PRP Injection
- What is being tested?
- Arthroscopic repair of shoulder rotator cuff tear and PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGreece
- Study dates
- 20 Nov 2021to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients enrolled had symptomatic rotator cuff tears, which were confirmed by magnetic resonance imaging (MRI). They had failed previous conservative management and physical therapy of at least 3 months and were candidates for surgical treatment.
Who cannot join
- acute shoulder trauma, (b) any history of a previous surgical operation on their shoulder, (c) the local administration of corticosteroids up to fifteen days before the operation or systemic administration of corticosteroids up to a month before the operation, (d) the use of non-steroidal anti-inflammatory drugs during the trial, (e) any signs of infection or systematic inflammatory disease for at least fifteen days before the operation, (f) history of malignancy or chemotherapy during the previous year, (g) rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head, (h) pregnancy or breastfeeding, and in case of any of these conditions the patients where ultimately excluded from the trial results.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the study:
The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear.
What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.
- Being tested
- Arthroscopic repair of shoulder rotator cuff tear, PRP injection
- 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.
Arthroscopic repair of shoulder rotator cuff tearProcedure or surgery
All patients received general anesthesia and were operated on in the "beach chair" position. Concerning the arthroscopic rotator cuff repair, systematic glenohumeral joint and subacromial exploration were performed, and lesions were managed as necessary. In each case, after the frayed and atrophied torn end was removed, the rotator cuff tear was carefully evaluated, and anteroposterior size, mediolateral retraction, number of involved tendons, visual tendon grade, excursion, and presence of the subscapularis tear were assessed. Debridement of bursal tissue and subacromial and distal clavicle osteophytes was minimally performed. Extensive acromioplasty to flatten a hooked or curved acromion was rarely performed. Rotator cuff repair was performed to cover the original footprint using suture anchors that were inserted through the accessory portal. The patients of both groups followed the same postoperative rehabilitation protocol.
PRP injectionBiological
The patients of treatment goup were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively. An autologous sample of 9 ml of peripheral blood was collected, and after addition of anticoagulant and preparation with a centrifuge for 6 minutes, 4ml of PRP was received and injected intraarticularly in a subacromial fashion.
| Study group | Role | What they receive |
|---|---|---|
| PRP Treatment Group | Experimental | The patients underwent arthroscopic repair of rotator cuff tear. They were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively. The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months. Receives: Procedure: Arthroscopic repair of shoulder rotator cuff tear; Biological: PRP injection |
| Control group | Active comparator | The patients underwent arthroscopic repair of rotator cuff tear. They did not receive any shoulder injection postoperatively. The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months. Receives: Procedure: Arthroscopic repair of shoulder rotator cuff tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Constant - Murley score
Measured: at 3, 6 and 12 months postoperatively
Change from baseline of ASES score
Measured: at 3, 6 and 12 months postoperatively
Secondary outcomes (2)
Rate of shoulder rotator cuff tendon retears
Measured: at 6 months postoperatively
Measurement of pain on a Numerical Rating Scale (NRS) of 0 to 15
Measured: at 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start20 Nov 2021
- Primary completion2 Feb 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAT General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Angelos Trantos, KAT General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689383
- Sponsor's protocol ID
- 18/08-06-2021
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trantos IA, Vasiliadis ES, Giannoulis FS, Fragkopoulou L, Pneumaticos SG. Contribution of platelet-rich plasma to the surgical treatment of rotator cuff tear: An experimental study. Biomed Rep. 2026 Aug 11;25(4):114. doi: 10.3892/br.2026.2187. eCollection 2026 Oct.
PubMed 42682799
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study
- ClinicalTrials.gov ID
- NCT07689383
- Acronym / sponsor ID
- 18/08-06-2021
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- KAT General HospitalUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 8 Jul 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.
Purpose of the study:
The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear.
What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Treatment Group | Experimental | Procedure: Arthroscopic repair of shoulder rotator cuff tear, Biological: PRP injectionThe patients underwent arthroscopic repair of rotator cuff tear. They were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively. The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months. |
| Control group | Active comparator | Procedure: Arthroscopic repair of shoulder rotator cuff tearThe patients underwent arthroscopic repair of rotator cuff tear. They did not receive any shoulder injection postoperatively. The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients enrolled had symptomatic rotator cuff tears, which were confirmed by magnetic resonance imaging (MRI). They had failed previous conservative management and physical therapy of at least 3 months and were candidates for surgical treatment.
Key exclusion criteria (1 listed)
- acute shoulder trauma, (b) any history of a previous surgical operation on their shoulder, (c) the local administration of corticosteroids up to fifteen days before the operation or systemic administration of corticosteroids up to a month before the operation, (d) the use of non-steroidal anti-inflammatory drugs during the trial, (e) any signs of infection or systematic inflammatory disease for at least fifteen days before the operation, (f) history of malignancy or chemotherapy during the previous year, (g) rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head, (h) pregnancy or breastfeeding, and in case of any of these conditions the patients where ultimately excluded from the trial results.
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 |
|---|---|---|
| Arthroscopic repair of shoulder rotator cuff tearAll patients received general anesthesia and were operated on in the "beach chair" position. Concerning the arthroscopic rotator cuff repair, systematic glenohumeral joint and subacromial exploration were performed, and lesions were managed as necessary. In each case, after the frayed and atrophied torn end was removed, the rotator cuff tear was carefully evaluated, and anteroposterior size, mediolateral retraction, number of involved tendons, visual tendon grade, excursion, and presence of the subscapularis tear were assessed. Debridement of bursal tissue and subacromial and distal clavicle osteophytes was minimally performed. Extensive acromioplasty to flatten a hooked or curved acromion was rarely performed. Rotator cuff repair was performed to cover the original footprint using suture anchors that were inserted through the accessory portal. The patients of both groups followed the same postoperative rehabilitation protocol. | Procedure or surgery | Control group, PRP Treatment Group |
| PRP injectionThe patients of treatment goup were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively. An autologous sample of 9 ml of peripheral blood was collected, and after addition of anticoagulant and preparation with a centrifuge for 6 minutes, 4ml of PRP was received and injected intraarticularly in a subacromial fashion. | Biological | PRP Treatment Group |
Primary outcome
Change from baseline of Constant - Murley score
Time frame: at 3, 6 and 12 months postoperatively
Change from baseline of ASES score
Time frame: at 3, 6 and 12 months postoperatively
2 secondary outcomes
Rate of shoulder rotator cuff tendon retears
Time frame: at 6 months postoperatively
Measurement of pain on a Numerical Rating Scale (NRS) of 0 to 15
Time frame: at 1 month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 42682799Trantos IA, Vasiliadis ES, Giannoulis FS, Fragkopoulou L, Pneumaticos SG. Contribution of platelet-rich plasma to the surgical treatment of rotator cuff tear: An experimental study. Biomed Rep. 2026 Aug 11;25(4):114. doi: 10.3892/br.2026.2187. eCollection 2026 Oct.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arthroscopic repair of shoulder rotator cuff tear and PRP injection in people with Rotator Cuff Tear and Rotator Cuff Repair of the Shoulder, run by KAT General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Constant - Murley score (time frame: at 3, 6 and 12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689383, which also lists 1 linked publication.
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 8 Jul 2026.