Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee Replacement
Recruiting · NCT05488093 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Osteoarthritis (OA) is the most common joint disease. It is characterized by a progressive destruction of all the components of the joint, especially the cartilage. This leads to pain, loss of mobility and can be a major handicap for some patients. Gonarthrosis, or osteoarthritis of the knee, affects 30% of people between the ages of 65 and 75 and is one of the most disabling conditions. In the final stage, the only therapeutic option to relieve patients is to replace the joint with a total knee prosthesis. Thanks to the contribution of an evaluation technique based on inertial sensors (X-SENS device), our objective is to better evaluate and understand the movement deficit in knee OA subjects. The hypothesis is that, thanks to the contribution of a technique based on inertial sensors (X-SENS), the investigators can better evaluate the movement deficit of knee OA subjects. The goal is to propose specific, rapid telekinetic biomarkers, allowing a better evaluation of functional improvements following therapeutic interventions, such as a total knee replacement.
Who can take part
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
Where it is running
1 location listed.
- University Hospital of Montpellier - Montpellier, France