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C3 Total Joint Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 10, 2014
First Posted Date July 11, 2014
Last Update Posted Date July 11, 2014
Study Start Date May 2012
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2014)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 10, 2014)
  • Adverse Events at time of surgery [ Time Frame: Time of surgery ]
  • Adverse Events at 6 weeks after surgery [ Time Frame: 6 weeks after surgery ]
    within 6 weeks but not less than 1 week 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title C3 Total Joint Patient Registry
Official Title Clinical Care Continuum (C3) Total Joint Patient Registry
Brief Summary 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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
Condition
  • Knee Replacement
  • Hip Replacement
Intervention Not Provided
Study Groups/Cohorts
  • Knee Replacement
    Patients undergoing knee replacement surgery
  • Hip Replacement
    Patients undergoing hip replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 10, 2014)
10000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02188199
Other Study ID Numbers C3 1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party DC2 Healthcare
Study Sponsor DC2 Healthcare
Collaborators
  • Clinical Care Continuum (C3) Foundation
  • National Research Independent Operations Management
Investigators Not Provided
PRS Account DC2 Healthcare
Verification Date July 2014