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

Primary Purpose

Osteoarthritis, OA

Status

Withdrawn

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

X-3 polyethylene

N2Vac polethylene

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee, total knee arthroplasty, gonarthrrsis, polyethylene, posterior stabilized

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

QEII Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

X-3

N2Vac polethylene

Arm Description

X-3 polyethylene which is a new highly cross-linked poly that is theorized to be more durable in vivo

conventional polyethylene

Outcomes

Primary Outcome Measures

survival rate of polyethylene

Secondary Outcome Measures

pain

function

radiographic outcomes

health related quality of life

adverse events

Full Information

NCT ID

NCT00665964

First Posted

April 22, 2008

Last Updated

January 30, 2019

Sponsor

Dalhousie University

Collaborators

Stryker Canada LP

1. Study Identification

Unique Protocol Identification Number

NCT00665964

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Not funded at this time.

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dalhousie University

Collaborators

Stryker Canada LP

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, OA

Keywords

osteoarthritis, knee, total knee arthroplasty, gonarthrrsis, polyethylene, posterior stabilized

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

X-3

Arm Type

Experimental

Arm Description

X-3 polyethylene which is a new highly cross-linked poly that is theorized to be more durable in vivo

Arm Title

N2Vac polethylene

Arm Type

Active Comparator

Arm Description

conventional polyethylene

Intervention Type

Device

Intervention Name(s)

X-3 polyethylene

Intervention Description

highly cross-linked polyethylene for knee arthroplasty

Intervention Type

Device

Intervention Name(s)

N2Vac polethylene

Intervention Description

conventional polyethylene

Primary Outcome Measure Information:

Title

survival rate of polyethylene

Time Frame

10 years

Secondary Outcome Measure Information:

Title

pain

Time Frame

10 years

Title

function

Time Frame

10 years

Title

radiographic outcomes

Time Frame

10 years

Title

health related quality of life

Time Frame

10 years

Title

adverse events

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J. Dunbar

Organizational Affiliation

Dalhousie University

Official's Role

Principal Investigator

Facility Information:

Facility Name

QEII Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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