NCT00665964

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

A Prospective, Randomized, Multi-center Study Comparing the Ten-Year Survival for X-3 Polyethylene to N2vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dalhousie University · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Osteoarthritis
• OA

Interventions

Type	Name	Description
DEVICE	X-3 polyethylene	highly cross-linked polyethylene for knee arthroplasty
DEVICE	N2Vac polethylene	conventional polyethylene

Timeline

• Start date: 2008-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2008-04-24
• Last updated: 2019-01-31

Locations

1 site across 1 country: Canada