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New treatment option for Knee Osteoarthritis
Official title Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee Replacement
ClinicalTrials.gov ID: NCT05488093
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join 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...
- 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 likely can't join 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°)
See the full eligibility 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))
- 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...)
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.