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

Osteoarthritis,Knee Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01899417
Study type Observational
Source Restor3D
Contact
Status Completed
Phase
Start date July 2013
Completion date March 2014
View Details
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