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| Name | Class |
|---|---|
| Clinical Care Continuum (C3) Foundation | UNKNOWN |
| National Research Independent Operations Management | OTHER |
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This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Replacement | Patients undergoing knee replacement surgery | ||
| Hip Replacement | Patients undergoing hip replacement |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina R Cook, PhD | Contact | 615-712-9574 | ccook@dc2healthcare.com | |
| Risa Tyo, PharmD | Contact | 615-712-9574 | rtyo@dc2healthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DC2 Healthcare | Recruiting | Nashville | Tennessee | 37211 | United States |
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| Label | URL |
|---|---|
| DC2 Healthcare | View source |
| NRIOM | View source |
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| 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 |