Clinical trial NCT00665964: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteoarthritis
OA
Keywords: osteoarthritis
knee
total knee arthroplasty
gonarthrrsis
polyethylene
posterior stabilized
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: Stryker Canada LP
First posted: 2008-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: survival rate of polyethylene
timeFrame: 10 years
Secondary outcomes:
measure: pain
timeFrame: 10 years
measure: function
timeFrame: 10 years
measure: radiographic outcomes
timeFrame: 10 years
measure: health related quality of life
timeFrame: 10 years
measure: adverse events
timeFrame: 10 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Michael J. Dunbar
role: PRINCIPAL_INVESTIGATOR
References: