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X-3 Polyethylene Survival Outcomes Study

NCT00493792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2024-11-06

Study results available
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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.

Conditions

  • Arthroplasty, Replacement, Knee
  • Total Knee Replacement

Interventions

DEVICE

X3 Polyethylene

Highly cross-linked polyethylene (HXLPE).

DEVICE

N2Vac Polyethylene

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

Sponsors & Collaborators

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Matthew Abdel, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493792 on ClinicalTrials.gov