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A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts

Knee Osteoarthritis Clinical Trial

Official title:
A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts

Clinical Trial Summary

This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.

Clinical Trial Description

The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03289754
Study type Interventional
Source Restor3D
Contact
Status Terminated
Phase N/A
Start date January 24, 2018
Completion date June 9, 2022
View Details
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