Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee
| Status: | Completed |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 5/5/2014 |
| Start Date: | July 2013 |
| End Date: | December 2013 |
Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee
The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal®
total knee replacement system versus standard total knee arthroplasty.
This study is designed to illustrate the difference in cost between standard total knee
replacements and the ConforMIS iTotal at a single institution.
total knee replacement system versus standard total knee arthroplasty.
This study is designed to illustrate the difference in cost between standard total knee
replacements and the ConforMIS iTotal at a single institution.
STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective
study. Patients enrolled will have previously received either an iTotal CR knee replacement
or a standard total knee replacement. The study site will be located in the United States.
A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a
maximum of 200 - 240 patients.
STUDY DURATION This study involves retrospective data collection of operative and
peri-operative information to determine the cost impact of several surgical variables. The
study will be complete when the retrospective data has been collected on up to 120 patients
per arm.
study. Patients enrolled will have previously received either an iTotal CR knee replacement
or a standard total knee replacement. The study site will be located in the United States.
A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a
maximum of 200 - 240 patients.
STUDY DURATION This study involves retrospective data collection of operative and
peri-operative information to determine the cost impact of several surgical variables. The
study will be complete when the retrospective data has been collected on up to 120 patients
per arm.
Inclusion Criteria:
- Patient has received an iTotal or a standard total knee replacement
- Willingness to participate in the clinical study and to give informed consent, if
necessary, as determined during IRB review
- >18 years of age
Exclusion Criteria:
- Participation in another clinical study that could confound results
- Patient is less than 3 months post-op
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