C3 Total Joint Patient Registry

Clinical Care Continuum (C3) Total Joint Patient Registry

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

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Recruiting
      • DC2 Healthcare
      • Contact: Christina R Cook, PhD; Phone Number: 615-712-9574; Email: ccook@dc2healthcare.com
      • Contact: Risa Tyo, PharmD; Phone Number: 615-712-9574; Email: rtyo@dc2healthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Knee Replacement; Patients undergoing knee replacement surgery
Hip Replacement; Patients undergoing hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events at time of surgery		Time of surgery
Adverse Events at 6 weeks after surgery	within 6 weeks but not less than 1 week 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

Collaborators and Investigators

• Sponsor: DC2 Healthcare
• Collaborators: National Research Independent Operations Management; Clinical Care Continuum (C3) Foundation

Publications and helpful links

Helpful Links

• DC2 Healthcare
• NRIOM

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 10, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Knee; Hip replacement; Knee replacement; Hip; Total Joint
• Other Study ID Numbers: C3 1001