osteoartritis
Conditions
Interventions
CR or BCR TKA (Vanguard System, Biomet, Inc., USA).
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Patient with non-inflammatory knee osteoarthritis, which is confirmed by radiology. •Osteoarthritis is unilateral of 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. •Patient plans to be available for follow-up until two years post-operative. •Patient is in stable health (ASA-score
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 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 quality 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 •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 posterior femoral rollback (i.e. translation) in mm from 30° flexion to 0° extension during the step-up test.The endpoint of this parameter is set at one year post-operative. This will be measured using MCM-based RFA (p18 in the protocol). | — |
Secondary
| Measure | Time frame |
|---|---|
| •the total anterior femoral rollback in mm from 0° extension to 90° flexion during the lunge test. This will also be done by using MCM-based RFA •3D migration (i.e. translation and rotation) in mm of the tibial and femoral component of the implant up and until 2 years (7.5 years for follow-up), using model-based radiostereometric analysis (MB-RSA, p19 protocol) •Lateral femoral lift-off in mm at 90° knee flexion during lunge test using MCM-based RFA. •AP laxity of knee 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) •Operative information | — |
Countries
Netherlands
Outcome results
None listed