osteoartritis primary total knee replacement
Conditions
Interventions
None listed
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient presenting with non-inflammatory osteoarthritis (radiologically confirmed), requiring total knee replacement - Patient has an intact PCL and patient has indication for a PCL-retaining Genesis II TKR - Patient is 40 to 70 years of age, inclusive - Patient plans to be available for follow up through 2 years postoperative. - Patient is in a stable health and is free of, or treated for, cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.
Exclusion criteria
Exclusion criteria: - Patient is known to have insufficient femoral or tibial bone stock - Patient has shown to have insufficient posterior cruciate ligament during surgery - 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, or is planned to have a (second) hip or knee replacement in the next 6-12 months - Patient has had major, non-arthroscopic surgery to the study knee, including HTO. - 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 - Patient has knee flexion 10 degrees (passive extension lag) - Patient has > 30 degrees extension deficit (active restraint to extension) - Patient has varus or valgus deformity >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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The postoperative medial tibiofemoral contact point of the knee in 90 degrees of flexion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antero-posterior stability of the knee, clinical and functional outcomes (Knee Society Score (KSS), KOOS, patellofemoral score), active and passive ROM, VAS pain and satisfaction. | — |
Countries
Netherlands
Outcome results
None listed