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A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

Osteoarthritis, Knee Clinical Trial

Official title:
A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems

Clinical Trial Summary

This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Clinical Trial Description

This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03146819
Study type Observational
Source Restor3D
Contact
Status Terminated
Phase
Start date December 16, 2016
Completion date May 31, 2017
View Details
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