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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
highly cross-linked polyethylene for knee arthroplasty
conventional polyethylene
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
survival rate of polyethylene
Time frame: 10 years
pain
Time frame: 10 years
function
Time frame: 10 years
radiographic outcomes
Time frame: 10 years
health related quality of life
Time frame: 10 years
adverse events
Time frame: 10 years
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