- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01787812
California Joint Replacement Registry (CJRR)
The California Joint Replacement Registry (CJRR) was created to meet the need for comprehensive, scientific assessment of devices, treatment protocols, surgical approaches, and patient factors influencing the results of hip and knee replacement surgeries. Importantly, it is a Level 3 registry, meaning it collects and incorporates clinical information and direct feedback from patients about the outcomes of hip and knee replacement surgeries. It is one of only a small number of registries in the United States to do so.
The CJRR's goals are to:
- Collect and report scientifically valid data on the results of hip and knee replacements performed in California, including device safety and effectiveness, post-operative complication and revision rates, and patient-reported outcomes; and
- Promote the use of performance information regarding hip and knee replacements to guide physician and patient decisions and to support programs for provider recognition and reward.
Specifically the CJRR is designed to:
- Minimize burden on participants by using electronic data sources, rather than manual data entry or chart review.
- Compile reports assessing the outcomes associated with different devices and surgical techniques.
- Create benchmarking reports for physicians and hospitals that detail performance data and compare it to statewide averages.
- Transmit safety alerts on devices with short-term results that provoke concern.
- Shape a measurement and reporting system for total hip and total knee replacement surgeries.
The CJRR was developed by the California HealthCare Foundation (CHCF), the Pacific Business Group on Health (PBGH), and the California Orthopaedic Association (COA). PBGH manages the day-to-day operations of the CJRR.
CJRR's data elements are aligned with other major orthopedic registries. The CJRR is a member of the International Consortium of Orthopedic Registries (ICOR) and the International Society of Arthroscopic Registries (ISAR).
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Irvine, California, Estados Unidos, 92618
- Reclutamiento
- Hoag Orthopedic Institute
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Contacto:
- Kanoelani Allen, MSN-CNS, PHN, RN
- Número de teléfono: 949.517.3138
- Correo electrónico: kallen@hoag.org
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Investigador principal:
- James Caillouette, M.D.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Receiving hip or knee replacement surgery in California.
Exclusion Criteria:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of Patients with Total Hip Replacement
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
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3 months, 6 months, every year up to 5 years
|
|
Number of Patients with Partial Hip Replacement
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
Number of Patients with Hip Revision
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
Number of Patients with Total Knee Replacement
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
Number of Patients with Knee Revision
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number and Type of Adverse Events as a Measure of Patient Safety
Periodo de tiempo: 3 months
|
Adverse Events:
|
3 months
|
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Number and Type of Readmissions as a Measure of Surgical Quality
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
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3 months, 6 months, every year up to 5 years
|
|
|
Number of Revisions as a Measure of Surgical Quality
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
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3 months, 6 months, every year up to 5 years
|
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|
Health-Related Quality of Life Score on the SF-12
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
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Pain Score on the WOMAC
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
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Stiffness Score on the WOMAC
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
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3 months, 6 months, every year up to 5 years
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|
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Physical Function Score on the WOMAC
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
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Activity Level Score on the UCLA Activity Index
Periodo de tiempo: 3 months, 6 months, every year up to 5 years
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3 months, 6 months, every year up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CJRR-2013
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