C3 Total Joint Patient Registry

Hip Replacement Clinical Trial

Official title:

Clinical Care Continuum (C3) Total Joint Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02188199
• Other study ID #: C3 1001
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2014
• Last updated: July 10, 2014
• Start date: May 2012

Study information

• Verified date: July 2014
• Source: DC2 Healthcare
• Contact: Christina R Cook, PhD
• Phone: 615-712-9574
• Email: ccook[@]dc2healthcare.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip Replacement
• Knee Replacement

Locations

Country	Name	City	State
United States	DC2 Healthcare	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
DC2 Healthcare	Clinical Care Continuum (C3) Foundation, National Research Independent Operations Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline and 3 months	No
Primary	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	baseline and 6 months	No
Primary	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	baseline and 1 year	No
Primary	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	baseline and 3 months	No
Primary	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	baseline and 1 year	No
Primary	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	baseline and 6 months	No
Secondary	Adverse Events at time of surgery		Time of surgery	Yes
Secondary	Adverse Events at 6 weeks after surgery	within 6 weeks but not less than 1 week after surgery	6 weeks after surgery	Yes
Secondary	Adverse Events at 3 months after surgery		3 months after surgery	Yes
Secondary	Adverse Events at 6 months after surgery		6 months after surgery	Yes
Secondary	Adverse Events at 1 year after surgery		1 year after surgery	Yes

External Links

•   C3 Healthcare
•   DC2 Healthcare
•   NRIOM