CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 518 enrolled
Drug / intervention
X3 Polyethylene +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00493792
NCT00493792N/ACompleted
CompareCT.gov

A Prospective, Randomized Study Comparing the Survival for X-3 Polyethylene to N2Vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System.

Mayo Clinic·interventional·Posted Jun 28, 2007·Updated Nov 6, 2024

In Brief

A clinical study evaluating X3 Polyethylene and N2Vac Polyethylene for Arthroplasty, Replacement, Knee and Total Knee Replacement. Completed, enrolled 518 participants across 3 sites.

Detailed Summary

The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected. It is hypothesized that X3 would perform equally well to N2Vac at 10 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthroplasty, Replacement, Knee, Total Knee Replacement
CountriesUnited States
CollaboratorsStryker Orthopaedics

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2007
Enrollment StartFeb 1, 2007
Primary CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 16.8 yearsPosted 19.0 years ago

Interventions

X3 Polyethylenedevice

Highly cross-linked polyethylene (HXLPE).

N2Vac Polyethylenedevice

Ultra-high-molecular-weight polyethylene (UHMWPE).