Osteoarthritis Musculoskeletal Diseases Arthrosis, unspecified
Conditions
Interventions
Patients are informed and screened pre-operative. Patients that comply with the inclusion/exclusion criteria and who give their consent for participation will be given a study ID. During surgery, the
Sponsors
Stryker European Operations BV (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form. 2. Patients with a pre-operative knee score of < 70. 3. Patients scheduled to undergo primary total knee replacement with any of the following indication. 3.1. Painful and disabled knee joint resulting from osteoarthritis. 3.2. One or more compartments are involved. 4. Need to obtain pain relief and improve function. 5. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations. 6. A good nutritional state of the patient. 7. Full skeletal maturity of the patient, patients who are at least 18 years of age. 8. Patients of either sex.
Exclusion criteria
Exclusion criteria: 1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 2. Skeletal immaturity of the patient, patients who are less than 18 years of age. 3. Patient has a flexion contracture of 15° and more. 4. Patient has a varus/valgus contracture of 15° and more. 5. Patients with a pre-operative knee score of >70. 6. The subject has a history of total or unicompartmental reconstruction of the affected joint. 7. The subject will be operated bilaterally. 8. 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). 9. 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). 10. The subject has an active or suspected latent infection in or about the knee joint 11. Osteomyelitis 12. Sepsis 13. Patients who will need lower limb joint replacement for another joint within one year. 14. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 15. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 16. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 17. The subject?s bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 18. The subject has had a knee fusion to the affected joint. 19. Female patients planning a pregnancy during the course of the study. 20. The patient is unable or unwilling to sign the Informed Consent specific to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed