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Clinical Trials/NCT02188199
NCT02188199
Unknown
Not Applicable

Clinical Care Continuum (C3) Total Joint Patient Registry

DC2 Healthcare1 site in 1 country10,000 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Replacement
Sponsor
DC2 Healthcare
Enrollment
10000
Locations
1
Primary Endpoint
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
December 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Adverse Events at time of surgery(Time of surgery)
  • Adverse Events at 6 weeks after surgery(6 weeks after surgery)
  • Adverse Events at 3 months after surgery(3 months after surgery)
  • Adverse Events at 6 months after surgery(6 months after surgery)
  • Adverse Events at 1 year after surgery(1 year after surgery)

Study Sites (1)

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