arthrosis knee wear
Conditions
Interventions
None listed
Sponsors
Spaarne Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with osteo-arthritis and or destruction of the knee joint Patients in the age >50 years Patient is willing to consent and participate in the study by signing and dating an IRB-approved consent form Patient willing to be available for follow-up evaluations through two years post-operative
Exclusion criteria
Exclusion criteria: Patients who are unable or unwilling to cooperate in follow¬-up program Patients who are mentally or cognitively disturbed No written and signed Informed Consent. Patient with a known sensitivity to materials in the device. Revision of uni or Total Condylar knee exchange Skeletal Immaturity Patellectomy Active, or local infection or systemic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the stability of the prosthesis, measured with RSA. Stability is defined as migration (mm) and rotation (degrees) of the tibial component in all degrees of freedom | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee disability and Osteoarthritis Outcome Score (KOOS) Numerical Rating Scale for pain SF 12 Migration and rotation at the timepoints postoperatively, 3 months, 6 months and 12 months postoperatively | — |
Countries
Netherlands
Outcome results
None listed