Polyethylene Wear Study on the Triathlon Total Knee Prosthesis_A Comparison of a Highly-crosslinked and a Crosslinked PE in-vivo
Completed
- Conditions
- knee arthrosisknee bearing10023213
- Registration Number
- NL-OMON40096
- Lead Sponsor
- Stryker SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
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.
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 > 40.
Patient has a flexion contracture of 15° and more.
The subject has an active or suspected latent infection in or about the knee joint
The subject has a history of total or unicompartmental reconstruction of the affected joint
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The primary objective is the assessment of the in vivo wear of the two<br /><br>randomized polyethylene inlay types N2Vac and X3 by means of Roentgen<br /><br>Stereophotogrammetry. It is expected that the X3 group will show significantly<br /><br>less wear after 5 years compared to the conventional N2Vac polyethylene group.</p><br>
- Secondary Outcome Measures
Name Time Method