Evaluating the Impact of Anchor Parameters on Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair: Prospective Cohort Study
| Registry | NCT07661680 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 70 (Estimated) |
| Sponsor | Fatih Sultan Mehmet Training and Research Hospital (Other) |
| Conditions | Rotator Cuff Tears, Tendon Thickening, Tendon Injuries, Muscle Weakness |
| Interventions | MRI (Diagnostic test) |
| Dates | start 2026-05-01, primary completion 2027-06-01 (estimated), completion 2027-08-01 (estimated), first posted 2026-06-22, last updated 2026-09-09 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Rotator Cuff Tears All trials for Tendon Thickening All trials of MRI
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arthroscopic Rotator Cuff Repair | Diagnostic Test: MRI | 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 |
Sex: All, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital | Istanbul | Turkey (Türkiye) |