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

January 30, 2019 updated by: Michael Dunbar, Dalhousie University

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject requires a primary cemented total knee replacement.
  • The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  • The subject has intact collateral ligaments.
  • The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
  • The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  • The subject has inflammatory arthritis.
  • The subject is morbidly obese, BMI > 40.
  • The subject has a history of total or unicompartmental reconstruction of the affected joint.
  • The subject has had a high tibial osteotomy or femoral osteotomy.
  • The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
  • The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
  • The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
  • The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
  • The subject has had a knee fusion at the affected joint.
  • The subject has an active or suspected latent infection in or about the knee joint.
  • The subject is a prisoner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: X-3
X-3 polyethylene which is a new highly cross-linked poly that is theorized to be more durable in vivo
Device: X-3 polyethylene
highly cross-linked polyethylene for knee arthroplasty
Active Comparator: N2Vac polethylene
conventional polyethylene
Device: N2Vac polethylene
conventional polyethylene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival rate of polyethylene
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 10 years
10 years
function
Time Frame: 10 years
10 years
radiographic outcomes
Time Frame: 10 years
10 years
health related quality of life
Time Frame: 10 years
10 years
adverse events
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalhousie University

Collaborators

Stryker Canada LP

Investigators

  • Principal Investigator: Michael J. Dunbar, Dalhousie University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RS/2007-249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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