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

Study Overview
=================
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)

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

Conditions
-----------------
OA, Osteoarthritis

Intervention / Treatment
-----------------
* Device: X-3 polyethylene
* Device: N2Vac polethylene


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate of polyethylene |  | 10 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, total knee arthroplasty, gonarthrrsis, polyethylene, posterior stabilized