degenerative joint disease Osteoarthritis
Conditions
Interventions
One group receives an uncemented total knee prosthesis with a CS insert, while
the other group receives an uncemented total knee prosthesis with a CR insert.
Both will be placed using the MAKO-robot
Sponsors
Reinier Haga Orthopedisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients scheduled to undergo primary total knee replacement with the MAKO-robotic arm, with one of the following indications: o Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis. o One or more compartments are involved; o Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability (meaning a varus, valgus or flexion deformity
Exclusion criteria
Exclusion criteria: • Contraindications of the manufacturer; • Metal in the operative or non-operative leg which lead to the creation of accuracy-reducing artefacts in the CT scan; • Body Mass Index (BMI) of > 35 kg/m2; • Flexion contracture of 15 degrees and more; • Varus/valgus contracture of 15 degrees and more; • History of total or unicompartmental reconstruction of the affected joint; • Bilateral operation; • A Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study); • A Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study); • Patients who will need lower limb joint replacement for another joint within one year. • Active or suspected latent infection in or about the knee joint; • Osteomyelitis; • Sepsis; • A systemic or metabolic disorder leading to progressive bone deterioration, excluding rheumatoid arthritis; • Vascular insufficiency, muscular atrophy; • Neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device; • Female patients planning a pregnancy during the course of the study; • The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. • Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis; • A knee fusion to the affected joint; • Patient has a known or suspected sensitivity or allergy to one or more of the implant materials; • Insufficient bone stock to provide adequate support and/or fixation to the prosthesis; • Unable or unwilling to sign the Informed Consent specific to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are migration of the femoral and tibial components measured with model-based RSA software till 10 years postoperatively. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or the marker inserter will be registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters are wear, inducible displacement, survival, clinical outcomes and complications up to 10 years postoperatively. | — |
Countries
Netherlands
Outcome results
None listed