Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee

Conditions
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Osteoarthritis,Knee

Intervention / Treatment
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* Device: ConforMIS iTotal® Knee Replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| ConforMIS iTotal® Knee Replacement<br>knee joint replacement | Device: ConforMIS iTotal® Knee Replacement<br>* Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.<br>* Other names: Standard total knee device;|
| Standard Knee Replacements<br>knee joint replacement | Device: ConforMIS iTotal® Knee Replacement<br>* Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.<br>* Other names: Standard total knee device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op | Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op | 1 month | 
| Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op | Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee replacement, patient-specific, economics