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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00665964
• Other study ID #: CDHA-RS/2007-249
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2008
• Est. completion date: May 2020

Study information

• Verified date: January 2019
• Source: Dalhousie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• OA
• Osteoarthritis

Intervention

Device:
• X-3 polyethylene
highly cross-linked polyethylene for knee arthroplasty
• N2Vac polethylene
conventional polyethylene

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Dalhousie University	Stryker Canada LP

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate of polyethylene		10 years
Secondary	pain		10 years
Secondary	function		10 years
Secondary	radiographic outcomes		10 years
Secondary	health related quality of life		10 years
Secondary	adverse events		10 years