Migration in a Cruciate Retaining and a Condylar Stabilizing Insert of a robot-assisted Uncemented Total Knee Prosthesis using Model-based RSA: a Mono-Center Randomized Controlled Trial with 10 years follow-up
- Conditions
- degenerative joint diseaseOsteoarthritis1002321310005944
- Registration Number
- NL-OMON53414
- Lead Sponsor
- Reinier Haga Orthopedisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 44
• 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 < 15 degrees);
• Age between 18 and 70 years;
• ASA score I or II;
• A good nutritional state of the patient;
• Patients with a completely intact PCL at the time of surgery;
• Patient is able to understand the study and is willing to participate and to
sign the Informed Consent;
• Patient is able to speak and write Dutch.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters are migration of the femoral and tibial components<br /><br>measured with model-based RSA software till 10 years postoperatively.<br /><br><br /><br>Furthermore, the stability of the markers will be determined and the<br /><br>complications due to the markers and/or the marker inserter will be registered. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary parameters are wear, inducible displacement, survival, clinical<br /><br>outcomes and complications up to 10 years postoperatively.</p><br>