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Polyethylene

X3 Polyethylene for Knee Replacement Surgery

N/A
Waitlist Available
Led By Michael J. Stuart, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial will compare two types of polyethylene to see which works better with a certain type of knee surgery.

Eligible Conditions
  • Total Knee Arthroplasty
  • Knee Replacement Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy parameter is the revision rate for total knee arthroplasty at 10 years post- surgery.
Secondary outcome measures
Active flexion, Passive flexion, Active extension, and Passive extension ROM at the 2, 5, 7 and 10-year visits.
KSS pain and motion scores at the 3 months, 2, 5, 7 and 10-year visit.
Radiographic failure is defined as a score of 10 or greater according to the Knee Society Rotenographic Scoring System, regardless of symptoms.
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.
Group II: 1Experimental Treatment1 Intervention
Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stryker X3 crosslink
2007
N/A
~520

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsIndustry Sponsor
77 Previous Clinical Trials
19,717 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,567 Total Patients Enrolled
Michael J. Stuart, M.D.Principal InvestigatorMayo Clinic

Media Library

Stryker X3 crosslink (Polyethylene) Clinical Trial Eligibility Overview. Trial Name: NCT00493792 — N/A
Total Knee Arthroplasty Research Study Groups: 2, 1
Total Knee Arthroplasty Clinical Trial 2023: Stryker X3 crosslink Highlights & Side Effects. Trial Name: NCT00493792 — N/A
Stryker X3 crosslink (Polyethylene) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00493792 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
X-3 Polyethylene Survival Outcomes Study
Matthew P. Abdel, M.D. 2007. "X-3 Polyethylene Survival Outcomes Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00493792.
~28 spots leftby Apr 2025
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