NCT07661680

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
May 2026Aug 2027

Study Start

First participant enrolled

May 1, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

May 13, 2026

Last Update Submit

July 2, 2026

Conditions

Tendon InjuriesRotator Cuff TearsTendon ThickeningMuscle Weakness

Keywords

Rotator Cuff RepairAnchorsPerianchor Cyst FormationFunctional Outcomes

Outcome Measures

Primary Outcomes (2)

  • Perianchor Cyst Volume

    To determine the effect of anchor-related surgical parameters on peri-anchor cyst volume.

    Up to 12 months

  • Deadman's Angle

    Relation between anchors angle and cyst volume

    Up to 12 months

Secondary Outcomes (5)

  • Tendon Healing Classification with using Sugaya Classification

    12 months after surgery.

  • Range of Motion

    Preoperatively and 6, and 12 months after surgery.

  • American Shoulder and Elbow Surgeons (ASES) Score

    Preoperatively and 6, and 12 months after surgery.

  • Constant-Murley Score (CMS)

    Preoperatively and 6, and 12 months after surgery.

  • Oxford Shoulder Score (OSS)

    Preoperatively and 6, and 12 months after surgery.

Study Arms (1)

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

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

Measure of Perianchor Cyst Formation using 3D Slicer Image Computing Platform

Also known as: Magnetic Resonance Imaging
Arthroscopic Rotator Cuff Repair

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 18-70 years
  • Undergoing primary arthoroscopic rotator cuff repair
  • Availability for MRI follow-up
  • Ability to provide informed constent

You may not qualify if:

  • Previous shoulder surgery
  • Active infection
  • Inflammatory joint disease
  • Acute traumatic massive tears
  • Inability to complete follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 31350085BACKGROUND

  • 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.

    PMID: 19501288BACKGROUND

MeSH Terms

Conditions

Rotator Cuff InjuriesTendon InjuriesMuscle Weakness

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • ONUR GULTEKIN, MD

    FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Orthopaedic Surgery Resident

Study Record Dates

First Submitted

May 13, 2026

First Posted

June 22, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)