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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Istanbul, Turquia (Türkiye), 340000
- Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Perianchor Cyst Volume
Prazo: Up to 12 months
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To determine the effect of anchor-related surgical parameters on peri-anchor cyst volume.
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Up to 12 months
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Deadman's Angle
Prazo: Up to 12 months
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Relation between anchors angle and cyst volume
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Up to 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Tendon Healing Classification with using Sugaya Classification
Prazo: 12 months after surgery.
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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.
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12 months after surgery.
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Range of Motion
Prazo: Preoperatively and 6, and 12 months after surgery.
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flextion, abduction, internat rotation, external rotation
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Preoperatively and 6, and 12 months after surgery.
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American Shoulder and Elbow Surgeons (ASES) Score
Prazo: Preoperatively and 6, and 12 months after surgery.
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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.
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Preoperatively and 6, and 12 months after surgery.
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Constant-Murley Score (CMS)
Prazo: Preoperatively and 6, and 12 months after surgery.
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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.
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Preoperatively and 6, and 12 months after surgery.
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Oxford Shoulder Score (OSS)
Prazo: Preoperatively and 6, and 12 months after surgery.
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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.
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Preoperatively and 6, and 12 months after surgery.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: ONUR GULTEKIN, MD, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Lesões no ombro
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças do Sistema Nervoso
- Doenças Musculares
- Manifestações Neuromusculares
- Ferimentos e Lesões
- Processos Patológicos
- Ruptura
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Lesões do Manguito Rotador
- Fraqueza muscular
- Lesões de tendão
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Tomografia
- Diagnóstico imagens
- Ressonância magnética
Outros números de identificação do estudo
- PAC-RCR-26
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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