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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT06351059
Eligibility Criteria:
Inclusion Criteria:
* Group A: persons judging themselves to be of good subjective health without any knee problems, aged 35-65 years
* Groups B\&C: participant in MAC registry, completed patient reported-outcome measurements (PROM) questionnaires at 2y or 5y within the last 6 months, aged 35-65 years, unilateral knee surgery (another side as internal control), B1/C1: the normal group is defined as patients closely around the median COMI scores of their respective group (determined medians are: 2yr females: 0.9 / 2yr males: 0.7 / 5yr females: 0.5 / 5yr males: 0.5), B2/C2: the poor outcomes group consists of patients with scores ≥ 2.
* Group D: patient booked for TKA due to severe OA, aged 35-75 years
Exclusion Criteria:
* inability to give consent or follow procedures
* no understanding of German language
* open wounds or tissue injuries
* irritated or infected sections on the limbs
* Class II obesity defined by Body Mass Index (BMI) ≥ 35 kg/m2 (comorbidities associated with obesity should be investigated in future studies)
* uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
* Pregnant or with intention to get pregnant (x-rays)
* Current address outside of Switzerland
* Groups B\&C: revision surgeries at the operated knee, death, known pathologies or former injuries of the comparator knee
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT06351059
Study Brief:
Protocol Section:
NCT06351059