joint wear osteoarthrits
Conditions
Interventions
None listed
Sponsors
Stryker Europe
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patient with non-inflammatory knee osteoarthritis which is radiologically confirmed and which requires total knee replacement * Age between 40 and 75 years, inclusive * Patient plans to be available for follow-up until two years post-operative * 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 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 (because of the effect on function) * Patient has had a previous hip replacement on the affected side (this may cause for a restriction for the rod placement during surgery) * 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 post-operative rehabilitation and follow-up * Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis * Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. i.e. due to loss of cartilage reported as *substantie verlies* * Patient has knee flexion 10 degrees (passive extension lag) * Patient has > 30 degrees extension deficit (active restraint to extension) * Patient does not have a proper functioning patella tendon on the affected side; measured as inability of active extension of the knee * Patient has quadriceps weakness on the affected side; score on MRC scale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The contour of the distal femur is quantified in (first): the flexion angle of the TKA in the sagittal plane. This angle is defined as the angle * between the bone stub axis of the femur and the neutral line of the femoral component of the prosthesis (see p14 protocol) | — |
Secondary
| Measure | Time frame |
|---|---|
| * The contour of the distal femur is further quantified in: The sagittal profile. The anterior sagittal profile is calculated as the mean length of three lines connecting trochlear axis of the distal femur in the sagittal plane and the outer anterior border of the femur/prosthesis (see protocol p15). * Functional outcome measured with: - Get up and Go test (GUG) - Stair climbing test as measure of ability to ascend, descend a flight of stairs. - Knee power output measured with the Leg Extensor Power Rig (see protocol p17) * Patient reported function scores: - Oxford Knee Score - KOOS-PS - KUJALA score * Clinician reported function scores: - Knee society score | — |
Countries
Netherlands
Outcome results
None listed