Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT05936593
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05936593
Study Brief:
Protocol Section:
NCT05936593