Knee ReplacementNCT02188199
C3 Total Joint Patient Registry
An observational study of Knee Replacement and Hip Replacement, run by DC2 Healthcare at 1 site in United States.
Trial summary
This study will assess the efficacy of products, implants, and procedures for knee and hip replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Replacement, Hip Replacement
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2016
- How long will I take part?
- 1 Year
- 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: The study population will come from cohorts of patients undergoing either knee or hip replacement in accordance with a nationwide multicenter observational study design. Eligibility criteria require only that patients are undergoing knee or hip replacement, are able to sign informed consent and are 18 years of age or older. Approximately 10,000 patients will be enrolled
Who may be able to join
- At least 18 years of age
- Undergoing knee or hip replacement
- Subject is likely to follow standard of care post-operative follow up for at least 1 year
Who cannot join
- Inability to complete follow-up visits or required questionnaires
- Inability to provide informed consent without a legally authorized representative
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DC2 Healthcare
Nashville, Tennessee, 37211
Christina R Cook, PhD, 615-712-9574, ccook@dc2healthcare.com
Risa Tyo, PharmD, 615-712-9574, rtyo@dc2healthcare.com
About this study
Official title: Clinical Care Continuum (C3) Total Joint Patient Registry
This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.
Read the detailed description
This registry will prospectively collect a core set of data on patients undergoing knee or hip replacement. This registry will include a variety of different products, implants, technologies and procedures. The registry will also collect any adverse events/complications that occur during or following these surgeries. This database can also be utilized in the future to answer research questions, by retrospectively going back through the data. This information also may go to insurance companies or hospitals for quality measurement and metrics reporting. The data will be utilized to develop strategic treatment pathways that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of treatment associated with knee and hip replacement and the resulting patient outcomes. The registry will also be used to provide quality measurement and metrics reporting.
- Conditions
- Knee Replacement, Hip Replacement
- Keywords
- Hip, Knee, Hip replacement, Knee replacement, Total Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Replacement | Patients undergoing knee replacement surgery | |
| Hip Replacement | Patients undergoing hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery
Measured: baseline and 3 months
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months
Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery
Measured: baseline and 6 months
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year
Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery
Measured: baseline and 1 year
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months
Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery
Measured: baseline and 3 months
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year
Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery
Measured: baseline and 1 year
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months
Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery
Measured: baseline and 6 months
Secondary outcomes (5)
Adverse Events at time of surgery
Measured: Time of surgery
Adverse Events at 6 weeks after surgery
within 6 weeks but not less than 1 week after surgery
Measured: 6 weeks after surgery
Adverse Events at 3 months after surgery
Measured: 3 months after surgery
Adverse Events at 6 months after surgery
Measured: 6 months after surgery
Adverse Events at 1 year after surgery
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ReplacementStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- DC2 Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Care Continuum (C3) Foundation, National Research Independent Operations Management
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188199
- Sponsor's protocol ID
- C3 1001
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Care Continuum (C3) Total Joint Patient Registry
- ClinicalTrials.gov ID
- NCT02188199
- Acronym / sponsor ID
- C3 1001
- Conditions
- Knee Replacement, Hip Replacement
- Keywords
- Hip, Knee, Hip replacement, Knee replacement, Total Joint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- DC2 HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Care Continuum (C3) Foundation, National Research Independent Operations Management
- Study start
- May 2012
- Primary completion
- Dec 2016 (estimated)
- First posted
- 11 Jul 2014 (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.
This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.
Detailed description
This registry will prospectively collect a core set of data on patients undergoing knee or hip replacement. This registry will include a variety of different products, implants, technologies and procedures. The registry will also collect any adverse events/complications that occur during or following these surgeries. This database can also be utilized in the future to answer research questions, by retrospectively going back through the data. This information also may go to insurance companies or hospitals for quality measurement and metrics reporting. The data will be utilized to develop strategic treatment pathways that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of treatment associated with knee and hip replacement and the resulting patient outcomes. The registry will also be used to provide quality measurement and metrics reporting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Replacement | – | –Patients undergoing knee replacement surgery |
| Hip Replacement | – | –Patients undergoing hip replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will come from cohorts of patients undergoing either knee or hip replacement in accordance with a nationwide multicenter observational study design. Eligibility criteria require only that patients are undergoing knee or hip replacement, are able to sign informed consent and are 18 years of age or older. Approximately 10,000 patients will be enrolled
Key inclusion criteria (3 listed)
- At least 18 years of age
- Undergoing knee or hip replacement
- Subject is likely to follow standard of care post-operative follow up for at least 1 year
Key exclusion criteria (2 listed)
- Inability to complete follow-up visits or required questionnaires
- Inability to provide informed consent without a legally authorized representative
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
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
Time frame: baseline and 3 months
Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months
Time frame: baseline and 6 months
Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year
Time frame: baseline and 1 year
Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months
Time frame: baseline and 3 months
Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year
Time frame: baseline and 1 year
Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months
Time frame: baseline and 6 months
Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery
5 secondary outcomes
Adverse Events at time of surgery
Time frame: Time of surgery
Adverse Events at 6 weeks after surgery
Time frame: 6 weeks after surgery
Adverse Events at 3 months after surgery
Time frame: 3 months after surgery
Adverse Events at 6 months after surgery
Time frame: 6 months after surgery
Adverse Events at 1 year after surgery
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- DC2 HealthcareLink provided by the sponsor.
- NRIOMLink provided by the sponsor.
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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 Knee Replacement and Hip Replacement, run by DC2 Healthcare 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 3 inclusion and 2 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 11 Jul 2014. 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 Christina R Cook, PhD (615-712-9574, ccook@dc2healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months (time frame: baseline and 3 months). The study lists 6 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 11 Jul 2014.