cartilage damage osteoarthrosis
Conditions
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
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
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 10 degrees • 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 degrees 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 Knee Score, VAS Satisfaction, number and type of Adverse Events, Hip-Knee-Ankle angle, Patellar tilt & displacement. | — |
Countries
Netherlands
Outcome results
None listed