- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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California
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Irvine, California, Estados Unidos, 92618
- Recrutamento
- Hoag Orthopedic Institute
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Contato:
- Kanoelani Allen, MSN-CNS, PHN, RN
- Número de telefone: 949.517.3138
- E-mail: kallen@hoag.org
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Investigador principal:
- James Caillouette, M.D.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Receiving hip or knee replacement surgery in California.
Exclusion Criteria:
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of Patients with Total Hip Replacement
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 3 months, 6 months, every year up to 5 years
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3 months, 6 months, every year up to 5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number and Type of Adverse Events as a Measure of Patient Safety
Prazo: 3 months
|
Adverse Events:
|
3 months
|
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Number and Type of Readmissions as a Measure of Surgical Quality
Prazo: 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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|
|
Number of Revisions as a Measure of Surgical Quality
Prazo: 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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Health-Related Quality of Life Score on the SF-12
Prazo: 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
Prazo: 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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Stiffness Score on the WOMAC
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- CJRR-2013
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