Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
The primary objective is the assessment of prosthetic migration results after two years of
 the Triathlon CS Knee System with all-polyethylene tibial components compared to the
 Triathlon CS Knee System with metal-backed modular components by means of Roentgen
 Stereophotogrammetry.
The secondary objective will be the prediction of the long-term survival based on the
 two-year migration patterns combined with clinical factors and radiographic aspects. In order
 to identify other clinical parameters besides the fixation of the prosthesis components,
 clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10
 years results will be used to verify the predicted long-term survival results.
1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 2. Patient has
 a flexion contracture of 15° and more. 3. Patient has a varus/valgus contracture of 15° and
 more. 4. Patients with a pre-operative knee score of >70. 5. The subject has a history of
 total or unicompartmental reconstruction of the affected joint. 6. The subject will be
 operated bilaterally. 7. 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). 8. 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). 9. The subject has an active or suspected latent infection in or about the
 knee joint. 10. Osteomyelitis 11. Sepsis 12. Patient who is expected to need lower limb
 joint replacement for another joint within one year. 13. The subject has a neuromuscular or
 neurosensory deficiency, which would limit the ability to assess the performance of the
 device. 14. The subject has a systemic or metabolic disorder leading to progressive bone
 deterioration. 15. The subject is immunologically suppressed or receiving steroids in
 excess of normal physiological requirements. 16. The subject's bone stock in compromised by
 disease or infection which cannot provide adequate support and/or fixation to the
 prosthesis. 17. The subject has had a knee fusion to the affected joint. 18. Female
 patients planning a pregnancy during the course of the study. 19. The patient is unable or
 unwilling to sign the Informed Consent specific to this study