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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT05488093
Eligibility Criteria:
Inclusion Criteria:
* Patient over 60 years old
* Presence of unilateral knee osteoarthritis (Kellgren and Lawrence radiographic stage ≥ 3) in the femorotibial compartment and/or Iwano stage ≥2 in the femoropatellar compartment);
* Average VAS (Visual Analogic Scale) pain on a reference joint (knee) \> 40/100 during the past month.
* Indication for prosthetic knee surgery (total knee replacement)
* Failure of a well-conducted medical treatment (at least one prior infiltration with corticoids or hyaluronic acid or PRP (Platelet-rich plasma))
Exclusion Criteria:
* Presence of an inflammatory joint disease (rheumatoid arthritis, spondyloarthritis, microcrystalline pathology)
* Presence of a post-traumatic gonarthrosis
* Frontal deformity of the lower limb \> 15
* Preoperative flessum \> 15° or preoperative knee mobility \< 90°
* Neurological pathology
* Spinal pathology that is painful or causes deformity (severe Cobb scoliosis \> 20°)
* History of trauma or surgery of the lower limbs in the last two years,
* Presence of at least one lower limb prosthesis (total hip or ankle prosthesis)
* Subject with a contraindication to MRI examination (pacemaker, neurosensory stimulators, cardiac defibrillator, cochlear implants, ferromagnetic ocular or cerebral foreign bodies...)
* Subjects with a contraindication to DXA examination (coronary stent or metallic cardiac sutures, pacemaker or automatic defibrillator, obesity with a BMI \> 35kg/m2, insulin pump, weight over 200kgs)
* Subject with a legal protection measure (guardianship, curatorship)
* Subject under legal protection
* Subject not affiliated to a social security system or not benefiting from such a system
* Absence of informed written consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05488093
Study Brief:
Protocol Section:
NCT05488093