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Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

6 september 2026 uppdaterad av: Muhammet Sivritaş, Fatih Sultan Mehmet Training and Research Hospital

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

70

Kontakter och platser

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Studieorter

  • Turkiet (Türkiye)
      • Istanbul, Turkiet (Türkiye), 340000
        • Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Diagnostiskt test: MRI
Measure of Perianchor Cyst Formation using 3D Slicer Image Computing Platform
Andra namn:
  • Magnetisk resonanstomografi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Perianchor Cyst Volume
Tidsram: 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
Tidsram: Up to 12 months
Relation between anchors angle and cyst volume
Up to 12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tendon Healing Classification with using Sugaya Classification
Tidsram: 12 months after surgery.
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.
12 months after surgery.
Range of Motion
Tidsram: Preoperatively and 6, and 12 months after surgery.
flextion, abduction, internat rotation, external rotation
Preoperatively and 6, and 12 months after surgery.
American Shoulder and Elbow Surgeons (ASES) Score
Tidsram: Preoperatively and 6, and 12 months after surgery.
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.
Preoperatively and 6, and 12 months after surgery.
Constant-Murley Score (CMS)
Tidsram: Preoperatively and 6, and 12 months after surgery.
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.
Preoperatively and 6, and 12 months after surgery.
Oxford Shoulder Score (OSS)
Tidsram: Preoperatively and 6, and 12 months after surgery.
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.
Preoperatively and 6, and 12 months after surgery.

Samarbetspartners och utredare

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Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Utredare

  • Huvudutredare: ONUR GULTEKIN, MD, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

13 maj 2026

Först inskickad som uppfyllde QC-kriterierna

16 juni 2026

Första postat (Faktisk)

22 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PAC-RCR-26

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NEJ

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