- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07826208
Added Diagnostic Value of CT Arthrography to MR Arthrography in Wrist Internal Derangement
Added Diagnostic Value of CT Arthrography to MR Arthrography in Suspected Wrist Internal Derangement
The wrist is a complex joint made up of small bones, cartilage, and stabilizing ligaments, including the triangular fibrocartilage complex (TFCC) and intrinsic carpal ligaments. Because these structures are small and intricate, diagnosing internal joint damage (internal derangement) after trauma or chronic pain can be challenging.
Magnetic resonance arthrography (MRA), an imaging scan performed after injecting a contrast dye into the joint, is widely used because it shows soft tissues clearly. However, MRA can sometimes miss subtle bone fragments, cartilage defects, or partial ligament tears due to lower spatial resolution. Computed tomography arthrography (CTA) provides higher-detail spatial imaging and excels at identifying small bone injuries and ligament tears, though it offers less soft-tissue contrast than MRI.
The purpose of this study is to determine whether performing CT arthrography in addition to MR arthrography improves the detection and characterization of internal wrist pathologies compared with MR arthrography alone.
Participants enrolled in this study will:
- Undergo a clinical history taking and examination regarding their wrist symptoms.
- Receive an ultrasound-guided injection into the radiocarpal joint using a sterile mixture containing iodinated contrast, gadolinium contrast, saline, and a local numbing medication (xylocaine).
- Undergo a high-resolution CT scan of the wrist immediately following the injection.
- Undergo a 1.5T MR arthrography scan.
Researchers will compare the findings between the two imaging techniques to evaluate how often adding CT arthrography identifies additional lesions that were occult or inconclusive on MR arthrography.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients aged 15 to 60 years.
- Clinically suspected ligamentous, cartilage, tendon, or occult osseous wrist injury.
- Patients scheduled for MR arthrography of the wrist.
Exclusion Criteria:
- History of previous wrist surgery.
- Acute fractures requiring emergency management.
- Active wrist infection.
- Contraindications to iodinated or gadolinium-based contrast agents.
- Regional metallic implants causing significant imaging artifacts.
- Pregnancy.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Combined CT and MR Arthrography
Participants with clinically suspected wrist internal derangement receive an ultrasound-guided intra-articular injection into the radiocarpal joint using a combined mixture of iodinated contrast, gadolinium-based contrast, sterile saline, and xylocaine.
Immediately following the injection, participants undergo high-resolution computed tomography arthrography (HRCT) of the affected wrist.
This is followed by 1.5T magnetic resonance arthrography (MRA) with pre-contrast and post-contrast T1 SPIR sequences in axial, coronal, and sagittal planes to assess wrist internal derangement.
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Under high-resolution ultrasound guidance, an intra-articular radiocarpal injection of approximately 5 mL is administered using a sterile mixture of iodinated contrast, gadolinium-based contrast, sterile saline, and xylocaine.
Immediately following injection, high-resolution CT arthrography is performed with 0.6 mm slice thickness and multiplanar reconstruction in axial, coronal, and sagittal planes.
Participants subsequently undergo 1.5T MR arthrography using coronal T2 SPIR (pre-contrast) and axial, coronal, and sagittal T1 SPIR sequences (post-contrast) using a dedicated wrist coil to evaluate internal derangement.
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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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Percentage of Patients With Additional Wrist Pathologies Detected by Adding CT Arthrography to MR Arthrography
Prazo: Baseline
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Assessed as the proportion of participants in whom CT arthrography identifies additional internal derangement lesions (including intrinsic scapholunate and lunotriquetral ligament tears, central triangular fibrocartilage complex tears, cartilage defects, and occult osseous abnormalities) that were missed, occult, or inconclusive on MR arthrography alone.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CTA & MRA in Wrist Derangement
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