Osteoarthritis Musculoskeletal Diseases Osteoarthritis
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. After signing Inform
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. No indication for Triathlon PS 5. Need to obtain pain relief and improve function 6. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations 7. A good nutritional state of the patient 8. The subject is a male or non-pregnant female between 40 and 75 years of age
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measure will be 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-year results will be used to verify the predicted long-term survival results. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be prosthetic migration after two years of the Triathlon PS Knee System with all-polyethylene tibial components and the Triathlon PS Knee System with metal backed modular components by means of Roentgen Stereophotogrammetry. It is hypothesized that there will be no difference between groups. The difference in migration between components must not exceed 0.3 mm for translations and 0.25° for the rotations to determine equivalence | — |
Countries
Sweden
Contacts
Public ContactChristina Silver
Outcome results
None listed