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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT02924961
Eligibility Criteria:
Inclusion Criteria:
* Patient (minimum age of 18 years old, no maximum age limit) is diagnosed with osteoarthritis or rheumatoid arthritis and requires primary arthroplasty.
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
* Patient has no major deformities (i.e. sagittal and coronal deformities are less then 15 degrees)
* The ability to perform a lunge and step-up motion without the help of bars or a cane.
* No or slight pain during activity according to the Knee Society Pain Score
Exclusion Criteria:
* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The individual has a functional impairment of any other lower extremity joint besides the operated knee
* Patient has a flexion contracture of 15° and more
* Patient has a varus/valgus contracture of 15° and more
* Patients requiring revision arthroplasty
* The patient does not understand the Dutch or English language good enough to participate.
* The use of walking aids
* The inability to walk more than 500 meters
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02924961
Study Brief:
Protocol Section:
NCT02924961