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

NCT ID: NCT00665964

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2020-05-31

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)

Conditions

Osteoarthritis; OA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

X-3

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

Group Type: EXPERIMENTAL

X-3 polyethylene

Intervention Type: DEVICE

highly cross-linked polyethylene for knee arthroplasty

N2Vac polethylene

conventional polyethylene

Group Type: ACTIVE_COMPARATOR

N2Vac polethylene

Intervention Type: DEVICE

conventional polyethylene

Interventions

X-3 polyethylene

highly cross-linked polyethylene for knee arthroplasty

Intervention Type: DEVICE

N2Vac polethylene

conventional polyethylene

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Canada LP

INDUSTRY

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: lead

Responsible Party

Michael Dunbar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J. Dunbar

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CDHA-RS/2007-249

Identifier Type: -

Identifier Source: org_study_id