Evaluation of Movement and Muscular Alterations in Subjects With Severe Knee Osteoarthritis Who Are to Receive a Total Knee Replacement

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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))

Locations
Other Locations
France
University Hospital of Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Yves-Marie PERS, MD-PhD
ym-pers@chu-montpellier.fr
04.67.33.72.31
Time Frame
Start Date: 2023-03-30
Estimated Completion Date: 2026-03
Participants
Target number of participants: 20
Treatments
Experimental: total knee replacement surgery group
The study will be conducted in 4 visits:~* a pre-inclusion visit during a routine care consultation where the patient will be informed about the study~* a V1 inclusion visit (pre-surgery of the knee) during which informed consent, clinical examination, VAS, self-questionnaires, DXA, X-SENS sensor, MRI, isokinetism will be collected~* a V2 visit during the operation, during which biological samples will be taken (muscle biopsy, collection of osteoarticular parts, and serum collection)~* a V3 visit at 12 months with a clinical examination, EVA, self-questionnaires, DXA, isokinetics, X-SENS sensor, serum collection, and collection of adverse events.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov

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