knee arthrosis knee bearing
Conditions
Interventions
All patients will have a total knee replacement operation during which the
prothesis and study layer or the control knee layer will be implanted.
Sponsors
Stryker SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary objective is the assessment of the in vivo wear of the two randomized polyethylene inlay types N2Vac and X3 by means of Roentgen Stereophotogrammetry. It is expected that the X3 group will show significantly less wear after 5 years compared to the conventional N2Vac polyethylene group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The secondary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Peri-Apatite coated tibial and femoral components by means of Roentgen Stereophotogrammetry. It is expected that due to the superior wear qualities of X3 polyethylene this group will show significantly less migration of the prosthesis* components after two-years compared to the components in the N2Vac group. 2. The third objective will be the prediction of the long-term survival of the Triathlon CS Peri-Apatite coated tibial and femoral components based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides wear influencing the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. Subsequently, a long-term prediction can be for the Triathlon CS Peri-Apatite coated tibial and femoral components. . | — |
Countries
Netherlands
Outcome results
None listed