Hip and Knee Replacement SurgeriesCJRRNCT01787812
California Joint Replacement Registry
An observational study of Hip and Knee Replacement Surgeries, run by California Joint Replacement Registry at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip and Knee Replacement Surgeries
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2014
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Californians, 18+ years of age, receiving hip or knee replacement surgery in California.
Who may be able to join
- Receiving hip or knee replacement surgery in California.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hoag Orthopedic Institute
Irvine, California, 92618
Kanoelani Allen, MSN-CNS, PHN, RN, 949.517.3138, kallen@hoag.org
James Caillouette, M.D.
About this study
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:
Read more
- 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).
- Conditions
- Hip and Knee Replacement Surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Total Hip Replacement
Measured: 3 months, 6 months, every year up to 5 years
Number of Patients with Partial Hip Replacement
Measured: 3 months, 6 months, every year up to 5 years
Number of Patients with Hip Revision
Measured: 3 months, 6 months, every year up to 5 years
Number of Patients with Total Knee Replacement
Measured: 3 months, 6 months, every year up to 5 years
Number of Patients with Knee Revision
Measured: 3 months, 6 months, every year up to 5 years
Secondary outcomes (8)
Number and Type of Adverse Events as a Measure of Patient Safety
Adverse Events:
- Would infection
- Fracture
- Excessive bleeding
- DVT proximal
- DVT
- PE
- Congestive heart
- Arrhythmia
- Renal failure
- Nerve injury
- MI
Measured: 3 months
Number and Type of Readmissions as a Measure of Surgical Quality
Measured: 3 months, 6 months, every year up to 5 years
Number of Revisions as a Measure of Surgical Quality
Measured: 3 months, 6 months, every year up to 5 years
Health-Related Quality of Life Score on the SF-12
Measured: 3 months, 6 months, every year up to 5 years
Pain Score on the WOMAC
Measured: 3 months, 6 months, every year up to 5 years
Stiffness Score on the WOMAC
Measured: 3 months, 6 months, every year up to 5 years
Physical Function Score on the WOMAC
Measured: 3 months, 6 months, every year up to 5 years
Activity Level Score on the UCLA Activity Index
Measured: 3 months, 6 months, every year up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJul 2011
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip and Knee Replacement SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- California Joint Replacement Registry
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787812
- Sponsor's protocol ID
- CJRR-2013
- Acronym
- CJRR
- Status last verified
- Jul 2013
- First submitted
- 1 Feb 2013
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- California Joint Replacement Registry
- ClinicalTrials.gov ID
- NCT01787812
- Acronym / sponsor ID
- CJRR / CJRR-2013
- Conditions
- Hip and Knee Replacement Surgeries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- California Joint Replacement RegistryResearch network
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Californians, 18+ years of age, receiving hip or knee replacement surgery in California.
Key inclusion criteria (1 listed)
- Receiving hip or knee replacement surgery in California.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients with Total Hip Replacement
Time frame: 3 months, 6 months, every year up to 5 years
Number of Patients with Partial Hip Replacement
Time frame: 3 months, 6 months, every year up to 5 years
Number of Patients with Hip Revision
Time frame: 3 months, 6 months, every year up to 5 years
Number of Patients with Total Knee Replacement
Time frame: 3 months, 6 months, every year up to 5 years
Number of Patients with Knee Revision
Time frame: 3 months, 6 months, every year up to 5 years
8 secondary outcomes
Number and Type of Adverse Events as a Measure of Patient Safety
Time frame: 3 months
Number and Type of Readmissions as a Measure of Surgical Quality
Time frame: 3 months, 6 months, every year up to 5 years
Number of Revisions as a Measure of Surgical Quality
Time frame: 3 months, 6 months, every year up to 5 years
Health-Related Quality of Life Score on the SF-12
Time frame: 3 months, 6 months, every year up to 5 years
Pain Score on the WOMAC
Time frame: 3 months, 6 months, every year up to 5 years
Stiffness Score on the WOMAC
Time frame: 3 months, 6 months, every year up to 5 years
Physical Function Score on the WOMAC
Time frame: 3 months, 6 months, every year up to 5 years
Activity Level Score on the UCLA Activity Index
Time frame: 3 months, 6 months, every year up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip and Knee Replacement Surgeries, run by California Joint Replacement Registry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Brodie (415.786.2204, rbrodie@pbgh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Total Hip Replacement (time frame: 3 months, 6 months, every year up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2013.