Migration of CS vs CR Insert in TKA Using RSA

Launched by REINIER HAGA ORTHOPEDISCH CENTRUM · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different types of inserts used in knee replacement surgery to see how well they perform over time. Specifically, it compares a "condylar (CS)" insert, which has a special design to mimic a ligament's function, with a "PCL-retaining (CR)" insert. Both inserts are made from a material designed to reduce wear, but the researchers want to find out if one type is more prone to movement or damage than the other, especially in younger, more active patients. The trial will involve 44 patients, all aged 18 to 70, who are scheduled for total knee replacement due to arthritis or other knee issues and have an intact posterior cruciate ligament.

Participants in the study will receive either the CS or CR insert during their knee surgery, which will be performed using advanced robotic technology for precision. Throughout the next ten years, researchers will monitor how well the implants hold up and look for any complications. If you are considering participating, it’s important to know that you must meet specific health criteria, like having a certain level of overall health and not having infections or other complications that could affect your surgery. This study aims to improve knee replacement outcomes and help future patients make informed choices about their treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients scheduled to undergo primary total knee replacement with the MAKO-robotic arm, with one of the following indications:
• • Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
• • One or more compartments are involved;
• • 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.
• Exclusion Criteria:
• * Contraindications manufacturer:
• • Any active or suspected latent infection in or about the knee joint;
• • Distant foci of infection which may cause hematogenous spread to the implant site;
• • Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care;
• • Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis;
• • Skeletal immaturity;
• • Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function;
• • 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;