Evaluating mobility in patients with severe knee osteoarthritis before knee replacement surgery
Evaluation of Movement and Muscular Alterations in Subjects With Severe Knee Osteoarthritis Who Are to Receive a Total Knee Replacement
This study is testing a new way to measure how well people with severe knee osteoarthritis can move before they have knee replacement surgery to help improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05488093 on ClinicalTrials.gov |
What this trial studies
This study aims to assess mobility in patients suffering from severe knee osteoarthritis who are scheduled for total knee replacement. Utilizing an innovative evaluation technique based on inertial sensors (X-SENS device), the researchers seek to better understand movement deficits in these patients. The study will involve measuring functional performance through wearable technology to capture a comprehensive view of mobility in daily activities. By identifying specific biomarkers related to functional improvement, the study hopes to enhance preoperative assessments and postoperative recovery strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 60 years old with unilateral knee osteoarthritis requiring total knee replacement.
Not a fit: Patients with inflammatory joint diseases, post-traumatic gonarthrosis, or significant lower limb deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved evaluation methods for knee osteoarthritis patients, potentially enhancing their recovery and quality of life post-surgery.
How similar studies have performed: Previous studies have explored mobility assessments in knee osteoarthritis, but the use of inertial sensors for this specific purpose is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- University Hospital of Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Yves-Marie PERS, MD-PhD
- Email: ym-pers@chu-montpellier.fr
- Phone: 04.67.33.72.31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.