Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee Replacement

NCT05488093 | Recruiting

• 1 other identifier: RECHMPL22_0051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; mobility; inertial sensors; sarcopenia

Outcome Measures

Primary Outcomes (1)

• Changes in inertial parameters before and after total knee replacement (TKR)

  Angular measurements in the sagittal plane during flexion and extension of the knee at 2 different times (before/after TKR) during functional movements by specifying the flexion angle at foot contact, the peak flexion angle at the beginning of the swing phase, the peak extension angle during the swing phase. Measurements will be taken with Xsens sensors

  between baseline and 12 months

Secondary Outcomes (27)

• percentage association of knee kinematics parameters with the pain VAS score at baseline

  at baseline

• percentage association of knee kinematics parameters with the pain VAS score at 12 months

  at 12 months

• percentage association of knee kinematics parameters with IPAQ score at baseline

  at baseline

• percentage association of knee kinematics parameters with IPAQ score at 12 months

  at 12 months

• percentage association of knee kinematics parameters with clinical parameters at baseline

  at baseline

Study Arms (1)

total knee replacement surgery group

EXPERIMENTAL

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.

Device: X-sens sensor

Interventions

X-sens sensor DEVICE

the procedure will include: * 7 to 8 sensors (Foot, leg, thigh, pelvis and chest possibly). * 5 movements/exercises for the patients, each exercise performed 3 times except walking * Analysis of 20m walking cycle (normal speed, most natural arm movement, 4 return trips of 20m): * Climbing up and down stairs (using the public stairs of the rheumatology access department, 6 steps of 20 cm height, at normal speed, without using the handrail) * Getting up from a chair without the help of hands (start standing, then the patient sits, leans and stands up, feet together, without taking the feet off the floor, using one and the same chair for each patient with a height of 50 cm)

total knee replacement surgery group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Sarcopenia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Yves-Marie PERS, MD-PhD

CONTACT

04.67.33.72.31; ym-pers@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: March 30, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)