NCT01899417

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 235 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis,Knee

Interventions

Type	Name	Description
DEVICE	ConforMIS iTotal® Knee Replacement	Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-07-15
• Last updated: 2023-10-25

Locations

1 site across 1 country: United States