- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07661680
Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair
Evaluating the Impact of Anchor Parameters on Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair: Prospective Cohort Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- Age 18-70 years
- Undergoing primary arthoroscopic rotator cuff repair
- Availability for MRI follow-up
- Ability to provide informed constent
Exclusion Criteria:
- Previous shoulder surgery
- Active infection
- Inflammatory joint disease
- Acute traumatic massive tears
- Inability to complete follow-up
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 |
Measure of Perianchor Cyst Formation using 3D Slicer Image Computing Platform
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perianchor Cyst Volume
Time Frame: Up to 12 months
|
To determine the effect of anchor-related surgical parameters on peri-anchor cyst volume.
|
Up to 12 months
|
|
Deadman's Angle
Time Frame: Up to 12 months
|
Relation between anchors angle and cyst volume
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tendon Healing
Time Frame: 6 months post-surgery
|
Sugaya Classification
|
6 months post-surgery
|
|
Range of Motion
Time Frame: 3-6-12 months
|
flextion, abduction, internat rotation, external rotation
|
3-6-12 months
|
|
Clinical Scores
Time Frame: 3-6-12 months
|
ASES
|
3-6-12 months
|
|
Clinical Scores
Time Frame: 3-6-12 months
|
Constant-Murley
|
3-6-12 months
|
|
Clinical Scores
Time Frame: 3-6-12 months
|
Oxford
|
3-6-12 months
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Strauss 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Shoulder Injuries
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Wounds and Injuries
- Pathologic Processes
- Rupture
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Rotator Cuff Injuries
- Muscle Weakness
- Tendon Injuries
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Magnetic Resonance Imaging
Other Study ID Numbers
- PAC-RCR-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tendon Injuries
-
Vastra Gotaland RegionCapio Group; ATLEVA FotcenterRecruitingTendon Injuries | Surgery | Tendon Rupture | Tendon TearSweden
-
Zimmer BiometEmbody Inc.Active, not recruiting
-
University of FloridaRecruitingProspective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon InjuriesFlexor TendonUnited States
-
Aarhus University HospitalEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon InjuryDenmark
-
Aristotle University Of ThessalonikiGeneral Hospital of Naoussa; Private Orthopedics Practice P. SymeonidisEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon Injury | Achilles Tendon SurgeryGreece
-
University of ZurichCompleted
-
University of Western Ontario, CanadaNot yet recruitingTendon Injury - Hand
-
University of HaifaZinman College of Physical Education and Sports SciencesCompletedAchilles Tendon InjuryIsrael
-
Rambam Health Care CampusCompletedHand Tendon InjuryIsrael
-
Mina Micheal Anwer FahmyUnknown
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
University of EdinburghCompleted
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupUnknownBreast Cancer | BIRADS 3 | BIRADS 4 | BIRADS 5United States
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Assistance Publique Hopitaux De MarseilleCompletedAmyotrophic Lateral SclerosisFrance
-
Medical University of ViennaCompletedBrachial Plexus Neuropathies | Traumatic Brachial Plexus Lesion | Bionic Hand ReconstructionAustria