[Ensayo de un dispositivo que no está aprobado ni autorizado por la FDA de EE. UU.]
[Ensayo de dispositivo que no está aprobado o autorizado por la FDA de EE. UU.]
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.
Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.
At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.
The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kristie Kennedy, MA
- Número de teléfono: 312-695-4023
- Correo electrónico: kristie.kennedy@northwestern.edu
Copia de seguridad de contactos de estudio
- Nombre: Robert Lewandowski, MD
- Número de teléfono: 312-695-9121
- Correo electrónico: r-lewandowki@northwestern.edu
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Reclutamiento
- Northwestern University
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Contacto:
- Robert Lewandowski, MD
- Número de teléfono: 312-695-9121
- Correo electrónico: r-lewandowski@northwestern.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 40-80 years
- Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
- Self-reported pain of at least 5/10 VAS questionnaire
- Failure of conservative therapy, such as pain medications, for at least 3 months
- Patient must understand and sign the informed consent
- Patient can comply with the proposed follow-up schedule
- Patient can follow the post-operative management
Exclusion Criteria:
- History of rheumatoid arthritis
- Renal insufficiency precluding angiography (GFR < 50 mL/min)
- Irreversible coagulopathy
- Previous knee arthroplasty on the intended knee
- Existing knee joint infection
- Kellgren-Lawrence grade 1 or 4
- Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses
- Life expectancy < 6 months
- Infectious arthritis
- Allergy to iodinated contrast resulting in anaphylaxis
- Pregnant or interested in becoming pregnant three months from the date of the GAE procedure
- Involved in litigation or worker's compensation claims
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: GAE Procedure
All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees.
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Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee.
Tiny particles are then injected through the catheter into these arteries, reducing the blood supply.
These small particles are considered a medical device called Embosphere Microspheres.
These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations.
The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient safety endpoints
Periodo de tiempo: Screening/baseline, 1, 3, and 6 months
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Primary safety endpoints include: 1. Incidence and severity of adverse events (AEs). These include:
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Screening/baseline, 1, 3, and 6 months
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Objective clinical endpoints - Cone beam computed tomography
Periodo de tiempo: Immediately pre-and post-embolization
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Change in enhancement on cone beam computed tomography (CT)
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Immediately pre-and post-embolization
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Objective clinical endpoints - VAS
Periodo de tiempo: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Change in Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain).
Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome
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Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Objective clinical endpoints - WOMAC
Periodo de tiempo: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis.
Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
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Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preliminary Effectiveness - WOMAC
Periodo de tiempo: Screening/baseline, 1, 3, 6, and 12 months
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Secondary endpoint will be evaluated based on existing validated pain scoring systems.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis will be utilized.
Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
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Screening/baseline, 1, 3, 6, and 12 months
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Preliminary Effectiveness - VAS
Periodo de tiempo: Screening/baseline, 1, 3, 6, and 12 months
|
Secondary endpoint will be evaluated based on existing validated pain scoring systems.
The Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain) will be utilized.
Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome.
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Screening/baseline, 1, 3, 6, and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Lewandowski, MD, Northwestern University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STU00223591
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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