Comparing two types of knee implant inserts in surgery

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

This study is testing whether a new type of knee implant insert works better and lasts longer than a traditional one for younger and more active patients getting knee replacement surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Reinier Haga Orthopedisch Centrum (Academic / other)
• Locations: 1 site (Zoetermeer, South Holland)
• Trial ID: NCT05936593 on ClinicalTrials.gov

What this trial studies

This study investigates the migration and wear of two different types of inserts used in total knee arthroplasty: the Condylar Stabilizing (CS) insert and the Cruciate Retaining (CR) insert. It aims to determine if the CS insert, which is designed to mimic the function of the posterior cruciate ligament, experiences more wear and migration compared to the CR insert, particularly in younger and more active patients. The research will utilize a robotic arm for precision in the surgical procedure and will monitor the long-term performance of both inserts. The findings could provide insights into the durability and effectiveness of these implants in knee replacement surgeries.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 70 scheduled for primary total knee replacement due to painful joint disease, with an intact posterior cruciate ligament.

Not a fit: Patients with active infections, severe deformities, or those unable to understand the study may not benefit from this research.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and longevity of knee implants for patients undergoing total knee arthroplasty.

How similar studies have performed: Previous studies have explored the performance of different knee implant designs, indicating potential for significant findings in this area.

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;

Where this trial is running

Zoetermeer, South Holland

• Reinier Haga Orthopedisch Centrum — Zoetermeer, South Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: J. Pasma

Conditions Wear of Articular Bearing Surface of Prosthetic Joint; Migration of Implant; Total knee arthroplasty; Insert