Rotator Cuff TearsNCT07661680
Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tears and Tendon Thickening, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Perianchor cyst formation is frequently observed after arthroscopic rotator cuff repair; however, its clinical significance remains unclear. This study aims to evaluate the relationship between anchor-related parameters and cyst formation, as well as their association with tendon healing and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tears, Tendon Thickening, Tendon Injuries
- What is being tested?
- MRI
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Aug 2027
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients with: * Partial- or full-thickness rotator cuff tears * Indication for surgical repair based on clinical and imaging findings * Ability to comply with postoperative follow-up and MRI evaluation The population is expected to represent a typical rotator cuff repair cohort in daily clinical practice.
Who may be able to join
- Age 18-70 years
- Undergoing primary arthoroscopic rotator cuff repair
- Availability for MRI follow-up
- Ability to provide informed constent
Who cannot join
- Previous shoulder surgery
- Active infection
- Inflammatory joint disease
- Acute traumatic massive tears
- Inability to complete follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 340000
About this study
Official title: Evaluating the Impact of Anchor Parameters on Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair: Prospective Cohort Study
Perianchor cyst formation is frequently observed after arthroscopic rotator cuff repair; however, its clinical significance remains unclear. This study aims to evaluate the relationship between anchor-related parameters and cyst formation, as well as their association with tendon healing and functional outcomes.
Read the detailed description
Perianchor cyst formation is a commonly observed finding on MRI after arthroscopic rotator cuff repair, but its clinical significance is still unclear. These cysts may be related to mechanical factors such as stress distribution around the anchor, micromotion at the bone-anchor interface, and local bone quality.
Different anchor materials (soft, PEEK, and metal) may behave differently in terms of load transfer and biological response. In addition, surgical factors such as the number of anchors used, their insertion angle, and the repair technique (single-row vs. double-row) may influence the formation and size of peri-anchor cysts. However, the combined effects of these variables have not been clearly defined.
Another important question is whether they reflect impaired tendon healing. Their relationship with tendon integrity, commonly evaluated using the Sugaya classification, remains uncertain. Similarly, it is not clear whether cyst characteristics are associated with clinical outcomes such as pain, shoulder function, and range of motion.
This prospective cohort study aims to evaluate the relationship between anchor-related parameters and perianchor cyst formation in a systematic way. The study will specifically analyze how anchor type, number, insertion angle, and repair configuration affect cyst volume and pericystic fluid accumulation.
In addition, the study will investigate whether peri-anchor cysts are associated with tendon healing and clinical outcomes. MRI findings will be correlated with validated clinical scores (ASES, Constant-Murley, VAS) and range of motion measurements.
A multivariable statistical model will be used to assess both independent and combined (interaction) effects of surgical variables. The potential of peri-anchor cysts as a predictive imaging biomarker for tendon healing and clinical outcomes will also be evaluated.
Overall, this study aims to better understand the clinical importance of peri-anchor cysts and to provide guidance for optimizing anchor selection and surgical technique in rotator cuff repair.
- Being tested
- MRI
- Keywords
- Rotator Cuff Repair, Anchors, Perianchor Cyst Formation, Functional Outcomes
- Medical subject headings
- Rotator Cuff Injuries, Tendon Injuries, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Magnetic Resonance Imaging
Measure of Perianchor Cyst Formation using 3D Slicer Image Computing Platform
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Rotator Cuff Repair | This study is designed as a single prospective observational cohort including patients undergoing primary arthroscopic rotator cuff repair.
All participants will be followed longitudinally to evaluate peri-anchor cyst formation and its relationship with surgical parameters, tendon healing, and clinical outcomes Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianchor Cyst Volume
To determine the effect of anchor-related surgical parameters on peri-anchor cyst volume.
Measured: Up to 12 months
Deadman's Angle
Relation between anchors angle and cyst volume
Measured: Up to 12 months
Secondary outcomes (5)
Tendon Healing Classification with using Sugaya Classification
Type I (sufficient thickness with homogeneous low intensity), Type II (sufficient thickness with partial high-intensity area), Type III (insufficient thickness without discontinuity), Type IV (minor discontinuity indicating a small retear), and Type V (major discontinuity indicating a medium or large retear). Types I-III are generally considered indicative of an intact repair, whereas Types IV and V represent retears.
Measured: 12 months after surgery.
Range of Motion
flextion, abduction, internat rotation, external rotation
Measured: Preoperatively and 6, and 12 months after surgery.
American Shoulder and Elbow Surgeons (ASES) Score
The American Shoulder and Elbow Surgeons (ASES) Score will be used to assess shoulder pain and functional status. The ASES is a validated, patient-reported outcome measure consisting of a pain visual analog scale (VAS) and 10 questions evaluating activities of daily living. Scores range from 0 to 100, with higher scores indicating better shoulder function and less pain.
Measured: Preoperatively and 6, and 12 months after surgery.
Constant-Murley Score (CMS)
The Constant-Murley Score (CMS) will be used to evaluate overall shoulder function. The CMS is a validated composite outcome measure that assesses pain, activities of daily living, range of motion, and shoulder strength. Total scores range from 0 to 100, with higher scores indicating better shoulder function.
Measured: Preoperatively and 6, and 12 months after surgery.
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) will be used to assess patient-reported shoulder pain and function. The OSS consists of 12 questions related to pain and activities of daily living experienced over the previous four weeks. Total scores range from 0 to 48, with higher scores indicating better shoulder function and lower levels of pain.
Measured: Preoperatively and 6, and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Sivritaş, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- ONUR GULTEKIN, MD, Principal investigator, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661680
- Sponsor's protocol ID
- PAC-RCR-26
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ro K, Pancholi S, Son HS, Rhee YG. Perianchor Cyst Formation After Arthroscopic Rotator Cuff Repair Using All-Suture-Type, Bioabsorbable-Type, and PEEK-Type Anchors. Arthroscopy. 2019 Aug;35(8):2284-2292. doi: 10.1016/j.arthro.2019.03.032. Epub 2019 Jul 23.
PubMed 31350085Strauss E, Frank D, Kubiak E, Kummer F, Rokito A. The effect of the angle of suture anchor insertion on fixation failure at the tendon-suture interface after rotator cuff repair: deadman's angle revisited. Arthroscopy. 2009 Jun;25(6):597-602. doi: 10.1016/j.arthro.2008.12.021. Epub 2009 Mar 17.
PubMed 19501288
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Anchor Parameters on Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07661680
- Acronym / sponsor ID
- PAC-RCR-26
- Keywords
- Rotator Cuff Repair, Anchors, Perianchor Cyst Formation, Functional Outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Jun 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.
Perianchor cyst formation is frequently observed after arthroscopic rotator cuff repair; however, its clinical significance remains unclear. This study aims to evaluate the relationship between anchor-related parameters and cyst formation, as well as their association with tendon healing and functional outcomes.
Detailed description
Perianchor cyst formation is a commonly observed finding on MRI after arthroscopic rotator cuff repair, but its clinical significance is still unclear. These cysts may be related to mechanical factors such as stress distribution around the anchor, micromotion at the bone-anchor interface, and local bone quality.
Different anchor materials (soft, PEEK, and metal) may behave differently in terms of load transfer and biological response. In addition, surgical factors such as the number of anchors used, their insertion angle, and the repair technique (single-row vs. double-row) may influence the formation and size of peri-anchor cysts. However, the combined effects of these variables have not been clearly defined.
Another important question is whether they reflect impaired tendon healing. Their relationship with tendon integrity, commonly evaluated using the Sugaya classification, remains uncertain. Similarly, it is not clear whether cyst characteristics are associated with clinical outcomes such as pain, shoulder function, and range of motion.
This prospective cohort study aims to evaluate the relationship between anchor-related parameters and perianchor cyst formation in a systematic way. The study will specifically analyze how anchor type, number, insertion angle, and repair configuration affect cyst volume and pericystic fluid accumulation.
In addition, the study will investigate whether peri-anchor cysts are associated with tendon healing and clinical outcomes. MRI findings will be correlated with validated clinical scores (ASES, Constant-Murley, VAS) and range of motion measurements.
A multivariable statistical model will be used to assess both independent and combined (interaction) effects of surgical variables. The potential of peri-anchor cysts as a predictive imaging biomarker for tendon healing and clinical outcomes will also be evaluated.
Overall, this study aims to better understand the clinical importance of peri-anchor cysts and to provide guidance for optimizing anchor selection and surgical technique in rotator cuff repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Rotator Cuff Repair | – | Diagnostic Test: MRIThis study is designed as a single prospective observational cohort including patients undergoing primary arthroscopic rotator cuff repair. All participants will be followed longitudinally to evaluate peri-anchor cyst formation and its relationship with surgical parameters, tendon healing, and clinical outcomes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with: * Partial- or full-thickness rotator cuff tears * Indication for surgical repair based on clinical and imaging findings * Ability to comply with postoperative follow-up and MRI evaluation The population is expected to represent a typical rotator cuff repair cohort in daily clinical practice.
Key inclusion criteria (4 listed)
- Age 18-70 years
- Undergoing primary arthoroscopic rotator cuff repair
- Availability for MRI follow-up
- Ability to provide informed constent
Key exclusion criteria (5 listed)
- Previous shoulder surgery
- Active infection
- Inflammatory joint disease
- Acute traumatic massive tears
- Inability to complete follow-up
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 |
|---|---|---|
| MRIAlso: Magnetic Resonance ImagingMeasure of Perianchor Cyst Formation using 3D Slicer Image Computing Platform | Diagnostic test | Arthroscopic Rotator Cuff Repair |
Primary outcome
Perianchor Cyst Volume
Time frame: Up to 12 months
To determine the effect of anchor-related surgical parameters on peri-anchor cyst volume.
Deadman's Angle
Time frame: Up to 12 months
Relation between anchors angle and cyst volume
5 secondary outcomes
Tendon Healing Classification with using Sugaya Classification
Time frame: 12 months after surgery.
Range of Motion
Time frame: Preoperatively and 6, and 12 months after surgery.
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Preoperatively and 6, and 12 months after surgery.
Constant-Murley Score (CMS)
Time frame: Preoperatively and 6, and 12 months after surgery.
Oxford Shoulder Score (OSS)
Time frame: Preoperatively and 6, and 12 months after surgery.
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 9 Sep 2026.
- Background: PubMed 31350085Ro K, Pancholi S, Son HS, Rhee YG. Perianchor Cyst Formation After Arthroscopic Rotator Cuff Repair Using All-Suture-Type, Bioabsorbable-Type, and PEEK-Type Anchors. Arthroscopy. 2019 Aug;35(8):2284-2292. doi: 10.1016/j.arthro.2019.03.032. Epub 2019 Jul 23.
- Background: PubMed 19501288Strauss E, Frank D, Kubiak E, Kummer F, Rokito A. The effect of the angle of suture anchor insertion on fixation failure at the tendon-suture interface after rotator cuff repair: deadman's angle revisited. Arthroscopy. 2009 Jun;25(6):597-602. doi: 10.1016/j.arthro.2008.12.021. Epub 2009 Mar 17.
- Individual participant dataSharing planned: No
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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.
ONUR GULTEKIN, MD principal investigator
FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears and Tendon Thickening, run by Fatih Sultan Mehmet Training and Research Hospital 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 5 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 9 Sep 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?
Perianchor Cyst Volume (time frame: Up to 12 months). 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 NCT07661680, which also lists 2 linked publications.
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 9 Sep 2026.