C3 Total Joint Patient Registry

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

Detailed Description
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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.

Official Title
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Clinical Care Continuum (C3) Total Joint Patient Registry

Conditions
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Knee Replacement, Hip Replacement

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee Replacement<br>Patients undergoing knee replacement surgery | |
| Hip Replacement<br>Patients undergoing hip replacement | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Knee, Hip replacement, Knee replacement, Total Joint