Rotator Cuff TearsNCT07853950
Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair
A study testing Arthroscopic Rotator Cuff Repair and Autologous Fibrin Clot in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate whether applying an autologous fibrin clot to the repair site improves tendon healing and clinical outcomes after arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- Arthroscopic Rotator Cuff Repair and Autologous Fibrin Clot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 28 Feb 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- Full-thickness or partial-thickness rotator cuff tear with an indication for arthroscopic surgical repair
- Goutallier fatty infiltration grade 1 or 2
- Written informed consent
Who cannot join
- Massive rotator cuff tear
- Advanced glenohumeral osteoarthritis
- Previous open shoulder surgery
- Serious comorbid disease (e.g., uncontrolled diabetes mellitus, advanced rheumatoid arthritis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Education and Research Hospital
Erzurum, Erzurum, 25240
About this study
Official title: Evaluation of the Efficacy of Autologous Fibrin Clot Applied to the Repair Interface in Arthroscopic Treatment of Rotator Cuff Tears: A Prospective, Randomized, Double-Blind Controlled Trial
The aim of this study is to evaluate whether applying an autologous fibrin clot to the repair site improves tendon healing and clinical outcomes after arthroscopic rotator cuff repair. Fifty patients with rotator cuff tears requiring surgery were randomly assigned to two groups: arthroscopic repair with autologous fibrin clot augmentation or standard arthroscopic repair alone. The fibrin clot is prepared from the patient's own blood without centrifugation. Tendon healing is assessed with magnetic resonance imaging (MRI) using the Sugaya classification at 12 months, and shoulder function and pain are assessed with the ASES score, Constant score and Visual Analog Scale (VAS) preoperatively and at 3, 6 and 12 months.
Read the detailed description
Rotator cuff tears are a common cause of shoulder pain and dysfunction, and retear after surgical repair remains a significant problem. Biological augmentation strategies aim to enhance healing at the tendon-bone interface. Autologous fibrin clot is a simple, low-cost biological augment that provides a fibrin scaffold containing platelets and growth factors, and it can be prepared intraoperatively without centrifugation or commercial kits.
In this prospective, randomized, double-blind controlled trial, 50 patients aged 18-80 years with full-thickness or partial-thickness rotator cuff tears (Goutallier fatty infiltration grade 1 or 2) and an indication for surgical repair were randomly allocated in a 1:1 ratio using a computer-generated randomization sequence to either the fibrin clot group (n=25) or the control group (n=25). Patients and outcome assessors are blinded to group allocation.
In the fibrin clot group, 40 mL of venous blood is drawn from the patient during surgery and stirred with a sterile glass rod until a fibrin clot forms. The clot is then delivered arthroscopically to the tendon-bone repair interface. The control group undergoes the same arthroscopic rotator cuff repair without fibrin clot application. Both groups follow the same postoperative rehabilitation protocol.
The primary outcome is rotator cuff repair integrity evaluated with MRI according to the Sugaya classification at 12 months postoperatively. Secondary outcomes are ASES score, Constant score and VAS pain score, assessed preoperatively and at 3, 6 and 12 months postoperatively.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Being tested
- Arthroscopic Rotator Cuff Repair, Autologous Fibrin Clot
- Keywords
- Rotator Cuff Repair, Fibrin Clot, Autologous Fibrin, Arthroscopy, Biological Augmentation, Tendon Healing, Retear, Sugaya Classification
- 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 Rotator Cuff RepairProcedure or surgery
Standard arthroscopic repair of the torn rotator cuff tendon to its footprint using suture anchors.
Autologous Fibrin ClotBiological
Also called Endogenous Fibrin Clot
40 mL of venous blood is drawn from the patient during surgery and stirred with a sterile glass rod until a fibrin clot forms, without centrifugation. The clot is delivered arthroscopically to the tendon-bone repair interface.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Clot Group | Experimental | Arthroscopic rotator cuff repair augmented with an autologous fibrin clot applied to the tendon-bone repair interface. Receives: Procedure: Arthroscopic Rotator Cuff Repair; Biological: Autologous Fibrin Clot |
| Control Group | Active comparator | Standard arthroscopic rotator cuff repair without fibrin clot augmentation. Receives: Procedure: Arthroscopic Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator Cuff Repair Integrity on MRI (Sugaya Classification)
Repair integrity is evaluated with magnetic resonance imaging and classified according to the Sugaya classification (Type I to V). Types I-III are considered healed and Types IV-V are considered retear. The proportion of healed repairs and the retear rate are compared between groups.
Measured: 12 months postoperatively
Secondary outcomes (1)
American Shoulder and Elbow Surgeons (ASES) Score
Patient-reported shoulder pain and function score ranging from 0 to 100, with higher scores indicating better shoulder function.
Measured: Preoperatively and at 3, 6 and 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 posted2 Oct 2026
- Study start15 Nov 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
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 TearsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Model description
- Patients were randomized in a 1:1 ratio to either arthroscopic rotator cuff repair with autologous fibrin clot augmentation or standard arthroscopic rotator cuff repair.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebubekir Safa Budak, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853950
- Sponsor's protocol ID
- ATAUNI-KAEK-2025-10
- Other IDs
- 2025-10
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient confidentiality. De-identified data may be made available by the principal investigator upon reasonable request.
Publications
Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.
PubMed 22495146
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Autologous Fibrin Clot Applied to the Repair Interface in Arthroscopic Treatment of Rotator Cuff Tears: A Prospective, Randomized, Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07853950
- Acronym / sponsor ID
- ATAUNI-KAEK-2025-10
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Keywords
- Rotator Cuff Repair, Fibrin Clot, Autologous Fibrin, Arthroscopy, Biological Augmentation, Tendon Healing, Retear, Sugaya Classification
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Oct 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 aim of this study is to evaluate whether applying an autologous fibrin clot to the repair site improves tendon healing and clinical outcomes after arthroscopic rotator cuff repair. Fifty patients with rotator cuff tears requiring surgery were randomly assigned to two groups: arthroscopic repair with autologous fibrin clot augmentation or standard arthroscopic repair alone. The fibrin clot is prepared from the patient's own blood without centrifugation. Tendon healing is assessed with magnetic resonance imaging (MRI) using the Sugaya classification at 12 months, and shoulder function and pain are assessed with the ASES score, Constant score and Visual Analog Scale (VAS) preoperatively and at 3, 6 and 12 months.
Detailed description
Rotator cuff tears are a common cause of shoulder pain and dysfunction, and retear after surgical repair remains a significant problem. Biological augmentation strategies aim to enhance healing at the tendon-bone interface. Autologous fibrin clot is a simple, low-cost biological augment that provides a fibrin scaffold containing platelets and growth factors, and it can be prepared intraoperatively without centrifugation or commercial kits.
In this prospective, randomized, double-blind controlled trial, 50 patients aged 18-80 years with full-thickness or partial-thickness rotator cuff tears (Goutallier fatty infiltration grade 1 or 2) and an indication for surgical repair were randomly allocated in a 1:1 ratio using a computer-generated randomization sequence to either the fibrin clot group (n=25) or the control group (n=25). Patients and outcome assessors are blinded to group allocation.
In the fibrin clot group, 40 mL of venous blood is drawn from the patient during surgery and stirred with a sterile glass rod until a fibrin clot forms. The clot is then delivered arthroscopically to the tendon-bone repair interface. The control group undergoes the same arthroscopic rotator cuff repair without fibrin clot application. Both groups follow the same postoperative rehabilitation protocol.
The primary outcome is rotator cuff repair integrity evaluated with MRI according to the Sugaya classification at 12 months postoperatively. Secondary outcomes are ASES score, Constant score and VAS pain score, assessed preoperatively and at 3, 6 and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomized in a 1:1 ratio to either arthroscopic rotator cuff repair with autologous fibrin clot augmentation or standard arthroscopic rotator cuff repair.
| Arm | Type | Receives |
|---|---|---|
| Fibrin Clot Group | Experimental | Procedure: Arthroscopic Rotator Cuff Repair, Biological: Autologous Fibrin ClotArthroscopic rotator cuff repair augmented with an autologous fibrin clot applied to the tendon-bone repair interface. |
| Control Group | Active comparator | Procedure: Arthroscopic Rotator Cuff RepairStandard arthroscopic rotator cuff repair without fibrin clot augmentation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- Full-thickness or partial-thickness rotator cuff tear with an indication for arthroscopic surgical repair
- Goutallier fatty infiltration grade 1 or 2
- Written informed consent
Key exclusion criteria (4 listed)
- Massive rotator cuff tear
- Advanced glenohumeral osteoarthritis
- Previous open shoulder surgery
- Serious comorbid disease (e.g., uncontrolled diabetes mellitus, advanced rheumatoid arthritis)
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 Rotator Cuff RepairStandard arthroscopic repair of the torn rotator cuff tendon to its footprint using suture anchors. | Procedure or surgery | Control Group, Fibrin Clot Group |
| Autologous Fibrin ClotAlso: Endogenous Fibrin Clot40 mL of venous blood is drawn from the patient during surgery and stirred with a sterile glass rod until a fibrin clot forms, without centrifugation. The clot is delivered arthroscopically to the tendon-bone repair interface. | Biological | Fibrin Clot Group |
Primary outcome
Rotator Cuff Repair Integrity on MRI (Sugaya Classification)
Time frame: 12 months postoperatively
Repair integrity is evaluated with magnetic resonance imaging and classified according to the Sugaya classification (Type I to V). Types I-III are considered healed and Types IV-V are considered retear. The proportion of healed repairs and the retear rate are compared between groups.
1 secondary outcome
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Preoperatively and at 3, 6 and 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 2 Oct 2026.
- Background: PubMed 22495146Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. doi: 10.1177/0363546512442924. Epub 2012 Apr 10.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient confidentiality. De-identified data may be made available by the principal investigator upon reasonable request.
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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 study testing Arthroscopic Rotator Cuff Repair and Autologous Fibrin Clot in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 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 Turkey (Türkiye). 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.
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?
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?
Rotator Cuff Repair Integrity on MRI (Sugaya Classification) (time frame: 12 months postoperatively). 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 NCT07853950, 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 2 Oct 2026.