- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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California
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Irvine, California, Forenede Stater, 92618
- Rekruttering
- Hoag Orthopedic Institute
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Kontakt:
- Kanoelani Allen, MSN-CNS, PHN, RN
- Telefonnummer: 949.517.3138
- E-mail: kallen@hoag.org
-
Ledende efterforsker:
- James Caillouette, M.D.
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Receiving hip or knee replacement surgery in California.
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of Patients with Total Hip Replacement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number and Type of Adverse Events as a Measure of Patient Safety
Tidsramme: 3 months
|
Adverse Events:
|
3 months
|
Number and Type of Readmissions as a Measure of Surgical Quality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
|
Stiffness Score on the WOMAC
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months, 6 months, every year up to 5 years
|
3 months, 6 months, every year up to 5 years
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CJRR-2013
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