Hip Replacement, Knee Replacement
Conditions
Keywords
Hip, Knee, Hip replacement, Knee replacement, Total Joint
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.
Interventions
None listed
Sponsors
Clinical Care Continuum (C3) Foundation
National Research Independent Operations Management
DC2 Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Adverse Events at time of surgery | Time of surgery | — |
Countries
United States
Contacts
Primary ContactChristina R Cook, PhD
Backup ContactRisa Tyo, PharmD
Outcome results
None listed