Patients receiving a primary total knee with a functional anterior cruciate ligament.
Conditions
Interventions
Participants will be randomly assigned to receive either the cruciate retaining or bicruciate retaining TKA both of which are commercially available and have a CE mark (Vanguard System, Biomet, Inc.,
Sponsors
Sint Maartenskliniek
Eligibility
Inclusion criteria
Inclusion criteria: • Patient with non-inflammatory knee osteoarthritis, which is confirmed by radiology. • Osteoarthritis is unilateral or bilateral with the contralateral knee functioning properly, not operated on in the last 6 months and not planned for TKA in the coming 2 years. • Patient is set to receive a primary cemented total knee arthroplasty. • Age between 40 and 75 years, inclusive, on the day of the operation. • Patient plans to be available for follow-up until two years post-operative. • Patient is in stable health (ASA-score ≤ 3) and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk. • Patient has a correctable or <10° rigid (non-correctable) varus or valgus deformity of the knee. • Participants must be able to give informed consent.
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 replacement surgery in the last 6 months, or is planned to have a hip replacement in the next 6-12 months (because of the effect on function). • Patient has had major, non-arthroscopic surgery to the study knee, including HTO. • Patient has an active, local infection or systemic infection • Prior high-energy trauma to the affected knee or prior history of anterior and/or posterior cruciate ligament rupture. • Suspicion of anterior and/or posterior cruciate ligament rupture at clinical examination. • Documented osteoporosis with patient in active medical treatment. • Patient has physical, emotional or neurological conditions that would compromise compliance with post-operative rehabilitation and follow-up. • Bone quality compromised by disease or infection 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 • 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 < 4 measured by research nurse • Patient has rheumatoid arthritis, any auto-immune disorder, immunosuppressive disorder or a terminal illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify the kinematics during functional tests the posterior femoral rollback (i.e. translation) in mm from 30° flexion to 0° extension during the step-up test will be measured. The endpoint of this parameter is set at one year post-operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The kinematics during functional tests are also quantified by measuring the total anterior femoral rollback in mm from 0° extension to 90° flexion during the lunge test. • 3D migration (i.e. translation and rotation) in mm of the tibial and femoral component of the implant referenced to the bone. • Lateral femoral lift-off in mm at 90° knee flexion during lunge test. • AP laxity of the knee in 20° and 90°, in mm from anterior to posterior using a rolimeter • Functional power output of the leg using the Leg extension power rig. • Patient and Clinician Reported Outcome Measures (PROMS and CROMS) | — |
Contacts
Public ContactM.R. Benard
Sint Maartenskliniek Nijmegen
Outcome results
None listed