Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

6. september 2026 oppdatert 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

70

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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
Diagnostisk test: MRI
Measure of Perianchor Cyst Formation using 3D Slicer Image Computing Platform
Andre navn:
  • Magnetisk resonansavbildning

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Perianchor Cyst Volume
Tidsramme: 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
Tidsramme: Up to 12 months
Relation between anchors angle and cyst volume
Up to 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tendon Healing Classification with using Sugaya Classification
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PAC-RCR-26

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere