Polyethylene Wear Study on the Triathlon Total Knee Prosthesis A Prospective Randomized Single Centre Roentgen Stereophotogrammetric Analysis (RSA) Study

Stryker Orthopaedics1 site in 1 country100 target enrollmentSeptember 2011

ConditionsArthroplasty, Replacement, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics
Enrollment: 100
Locations: 1
Primary Endpoint: Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.

Detailed Description

The goal of this study is to compare conventional UHMWPE with X3 highly cross-linked polyethylene in a CS fixed bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA) by means of RSA and clinical evaluation.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

March 28, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stryker Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
•Patients with a pre-operative knee score of \<
•Patients scheduled to undergo primary total knee replacement with any of the following indication.
•Painful and disabled knee joint resulting from osteoarthritis.
•One or more compartments are involved.
•Need to obtain pain relief and improve function.
•Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
•A good nutritional state of the patient.
•Full skeletal maturity of the patient, patients who are at least 18 years of age.
•Patients of either sex.

Exclusion Criteria

•The subject is morbidly obese, defined as Body Mass Index (BMI) of \>
•Skeletal immaturity of the patient, patients who are less than 18 years of age.
•Patient has a flexion contracture of 15° and more.
•Patient has a varus/valgus contracture of 15° and more.
•Patients with a pre-operative knee score of \>
•The subject has a history of total or unicompartmental reconstruction of the affected joint.
•The subject will be operated bilaterally.
•Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study).
•Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study).
•The subject has an active or suspected latent infection in or about the knee joint.

Outcomes

Primary Outcomes

Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).

Time Frame: 1, 2 and 5 years follow-up

RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene.

Secondary Outcomes

Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)
Assessment of Prosthetic Migration Results After Two Years by RSA.(3 and 6 months,1, 2 and 5 years follow-up)
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire(Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years)