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C3 Total Joint Patient Registry

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ClinicalTrials.gov Identifier: NCT02188199
Recruitment Status : Unknown
Verified July 2014 by DC2 Healthcare.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Collaborators:
Clinical Care Continuum (C3) Foundation
National Research Independent Operations Management
Information provided by (Responsible Party):
DC2 Healthcare

Study Description
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Brief Summary:
This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.

Condition or disease
Knee Replacement 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Clinical Care Continuum (C3) Total Joint Patient Registry
Study Start Date : May 2012
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Groups and Cohorts
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Group/Cohort
Knee Replacement
Patients undergoing knee replacement surgery
Hip Replacement
Patients undergoing hip replacement


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. Adverse Events at time of surgery [ Time Frame: Time of surgery ]
  2. Adverse Events at 6 weeks after surgery [ Time Frame: 6 weeks after surgery ]
    within 6 weeks but not less than 1 week after surgery

  3. Adverse Events at 3 months after surgery [ Time Frame: 3 months after surgery ]
  4. Adverse Events at 6 months after surgery [ Time Frame: 6 months after surgery ]
  5. Adverse Events at 1 year after surgery [ Time Frame: 1 year after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to complete follow-up visits or required questionnaires
  • Inability to provide informed consent without a legally authorized representative
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188199


Contacts
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Contact: Christina R Cook, PhD 615-712-9574 ccook@dc2healthcare.com
Contact: Risa Tyo, PharmD 615-712-9574 rtyo@dc2healthcare.com

Locations
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United States, Tennessee
DC2 Healthcare Recruiting
Nashville, Tennessee, United States, 37211
Contact: Christina R Cook, PhD    615-712-9574    ccook@dc2healthcare.com   
Contact: Risa Tyo, PharmD    615-712-9574    rtyo@dc2healthcare.com   
Sponsors and Collaborators
DC2 Healthcare
Clinical Care Continuum (C3) Foundation
National Research Independent Operations Management
More Information
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Additional Information:
DC2 Healthcare  This link exits the ClinicalTrials.gov site C3 Healthcare  This link exits the ClinicalTrials.gov site NRIOM  This link exits the ClinicalTrials.gov site

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Responsible Party: DC2 Healthcare
ClinicalTrials.gov Identifier: NCT02188199     History of Changes
Other Study ID Numbers: C3 1001
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Keywords provided by DC2 Healthcare:
Hip
Knee
Hip replacement
Knee replacement
Total Joint