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:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT04037735
Eligibility Criteria:
Inclusion Criteria:
* Patient is diagnosed with osteoarthritis and requires primary knee arthroplasty
* All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
Exclusion Criteria:
* The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.
* Insufficiency of the posterior cruciate ligament (PCL)
* Status after patellectomy
* In case flexion is less than 90 degrees
* The patient is diagnosed with Rheumatoid Arthritis
* When it is expected that the tibia cut during surgery will compromise the attachment of the PCL (because of bony defects)
* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The patient does not understand the Dutch or English language good enough to participate
* Patients indicated for revision arthroplasty instruments because of bone defects or deformity of the bone
* When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT04037735
Study Brief:
Protocol Section:
NCT04037735