C3 Total Joint Patient Registry

• Conditions: Hip Replacement; Knee Replacement

• Registration Number: NCT02188199
• Lead Sponsor: DC2 Healthcare

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 Timeline

• Study Start: 2012-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months	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	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	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	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	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	baseline and 6 months	Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Adverse Events at time of surgery	Time of surgery
Adverse Events at 6 weeks after surgery	6 weeks after surgery	within 6 weeks but not less than 1 week 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

Trial Locations

Locations (1)

DC2 Healthcare; 🇺🇸 Nashville, Tennessee, United States