non-inflammatory knee osteoarthritis total knee arthroplasty knie artrose totale knieprothese
Conditions
Interventions
The trial treatments are the Visionaire Patient Matched Instrumentation or the standard instrumentation of the Genesis II. All patients will receive associated hospital preoperative, per-operative and
Sponsors
Sint Maartenskliniek Nijmegen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient presents with non-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty; 2. Patient is 40 to 70 years of age, inclusive; 3. Patient plans to be available for follow-up through one year postoperative; 4. Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk; 5. Patient has <10 degrees fixed (non-correctable) varus or valgus deformity; 6. Patient is of the Caucasian race.
Exclusion criteria
Exclusion criteria: 1. Patient is known to have insufficient femoral or tibial bone stock; 2. Patient has a BMI >35; 3. Patient’s expected physical activity after surgery is 2 or less on the UCLA Activity Scale; 4. Patient has had previous hip or knee replacement surgery in the last 6 months; 5. Patient is planned to have additional hip or contralateral knee replacement in the next 6 months; 6. Patient has had major, non-arthroscopic surgery to the study knee, including osteotomy around the knee; 7. Patient has an active, local infection or systemic infection; 8. Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up; 9. Patient has grade 3 collateral ligament insufficiency (complete tear of ligament); 10. Patient has knee flexion 10; 12. Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder; 13. Patient is pregnant or plans to become pregnant during course of study; 14. Patient has a known sensitivity to materials in the device and/or cutting blocks; 15. Patient has >30 degrees extension deficit; 16. Patient has contra-indications for MRI.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are the clinical, functional and radiological outcomes 1 year postoperatively. | — |
Primary
| Measure | Time frame |
|---|---|
| The varus/valgus laxity in flexion and extension, and the axial alignment. | — |
Contacts
Public ContactJanneke Schimmel
Sint Maartenskliniek Hengstdal 3 PO Box 9011
Outcome results
None listed