Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System

Status Withdrawn

Clinical Trial Summary

Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system.

Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration

Multi-centre study

Objectives

Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used.

Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups.

Number of Subjects 384 cases (197 each group)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00665964
Study type	Interventional
Source	Dalhousie University
Contact
Status	Withdrawn
Phase	Phase 4
Start date	May 2008
Completion date	May 2020

View Details

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