- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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).
연구 개요
상태
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
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California
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Irvine, California, 미국, 92618
- 모병
- Hoag Orthopedic Institute
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연락하다:
- Kanoelani Allen, MSN-CNS, PHN, RN
- 전화번호: 949.517.3138
- 이메일: kallen@hoag.org
-
수석 연구원:
- James Caillouette, M.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Receiving hip or knee replacement surgery in California.
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Number of Patients with Total Hip Replacement
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
Number of Patients with Partial Hip Replacement
기간: 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
기간: 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
기간: 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
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number and Type of Adverse Events as a Measure of Patient Safety
기간: 3 months
|
Adverse Events:
|
3 months
|
|
Number and Type of Readmissions as a Measure of Surgical Quality
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Number of Revisions as a Measure of Surgical Quality
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Health-Related Quality of Life Score on the SF-12
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Pain Score on the WOMAC
기간: 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
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Physical Function Score on the WOMAC
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
|
Activity Level Score on the UCLA Activity Index
기간: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CJRR-2013
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .