non-inflammatory knee osteoarthritis primary total knee arthroplasty knie artrose primaire knieprothese
Conditions
Interventions
The trial treatment is the Journey II BCS Total Knee System, which has been cleared for use by the FDA through the 510(k) process in the US and has been CE-marked in Europe.
All patients will recei
Sponsors
St Maartenskliniek Nijmegen
Eligibility
Inclusion criteria
Inclusion criteria: •Patient presents with non-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty •Patient is 40 to 70 years of age, inclusive •Patient plans to be available for follow-up through two years postoperative •Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk •Patient has <10 fixed (non-correctable) varus or valgus deformity •Orthopaedic surgeon is member of the Knee Reconstruction Unit
Exclusion criteria
Exclusion criteria: •Patient is known to have insufficient femoral or tibial bone stock •Patient has a BMI >35 •Patient’s expected physical activity after surgery is 2 or less on the UCLA Activity Scale •Patient has had previous hip or knee replacement surgery in the last 6 months •Patient is planned to have additional hip or contralateral knee replacement in the next 6 months •Patient has had major, non-arthroscopic surgery to the study knee, including osteotomy around the knee •Patient has an active, local infection or systemic infection •Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up •Patient has grade 3 collateral ligament insufficiency (complete tear of ligament) •Patient has knee flexion 20 •Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder •Patient is pregnant or plans to become pregnant during course of study •Patient has a known sensitivity to materials in the device and/or cutting blocks •Patient has >30 extension deficit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal passive knee flexion measured on a lateral X-ray one year after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical, functional and radiological performance as measured with: active flexion (lying and standing), KSS, EQ-5d, KOOS, Kujala, Forgotten Joint Score, VAS Satisfaction, number and type of Adverse Events, Hip-Knee-Ankle angle, Patellar tilt & displacement. | — |
Contacts
Public ContactPetra Heesterbeek
Sint Maartenskliniek Research, Development en Education Hengstdal 3
Outcome results
None listed