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

NCT00665964 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-01-31

No results posted yet for this study

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

Interventions

DEVICE

X-3 polyethylene

highly cross-linked polyethylene for knee arthroplasty

DEVICE

N2Vac polethylene

conventional polyethylene

Sponsors & Collaborators

  • Stryker Canada LP

    collaborator INDUSTRY

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Michael J. Dunbar · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665964 on ClinicalTrials.gov