Osteoarthritis, Osteoarthritis, Knee, Osteo Arthritis Knee
Conditions
Keywords
Osteoarthritis, Knee, MRgFUS, ExAblate, Pain, High-Intensity Focused Ultrasound Ablation
Brief summary
A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused by knee osteoarthritis (OA)
Detailed description
Osteoarthritis (OA) is a common, disabling, and costly disease, and the knee is one of the most affected joints. The predominant symptom is pain. Effective and lasting non-invasive treatment approaches are missing. MR-guided focused ultrasound surgery (MRgFUS) is a new minimally invasive technique which may represent a valid solution providing several advantages. The primary aim of this work will be to assess the efficacy of MRgFUS in the treatment of pain caused by knee OA in 80 patients candidate for arthroplasty in a prospective, randomized, double-blinded, placebo-controlled clinical trial. Different parameters related to pain, quality of life, function, and imaging will be collected and analyzed in a 12-month follow-up. The secondary aims will be focused on a) the evaluation of the effects on the joint organ and changes of biological features in response to MRgFUS, and b) the impact of selective ablation of nociceptors on OA pain, based on the analysis of resected joint tissues.
Interventions
DEVICEMRgFUS Treatment
Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
OTHERPlacebo
Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participating patients will be blinded to treatment assignment and to the ongoing results of the study; they will remain blinded to their assignment throughout the study period. All the staff involved in the pre- and post-treatment evaluation of patients will be also blinded. The evaluation of patients will be performed by physicians not involved in the treatment to ensure double blinding.
Intervention model description
Double-blind placebo-controlled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female aged 50-80 years * Activity-related joint pain * Patients who have not responded to previous treatments and patients candidate for surgery * Kellgren-Lawrence score 2-4 on X-rays * Patients able to give their informed consent
Exclusion criteria
* Prior surgery in the past 12 months or previous local treatment in the past 3 months * Changes in medications used during the previous 2 months * Corticosteroid use for more than 3 months within the preceding year * Rheumatologic and neurological disorders * Fibromyalgia * Trauma, fracture or osteomyelitis of the investigated joints within the preceding year * Pregnancy * Patients with large scars potentially included in the ultrasound beam path * General contraindications to MRI and/or to anaesthesiological procedures * Presence of internal hardware or device potentially affecting MR thermometry * Patients involved in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of MRgFUS in the treatment of pain caused by knee OA | Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12 | The efficacy of MRgFUS will be demonstrated if the treatment group has a mean reduction of Visual Analog Pain Scale (VAS) of at least 1.5 points greater than the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of MRgFUS on the joint organ: inflammation | Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12 | Enzyme linked immuno assays kits will be used to test inflammatory markers in serum. The reference standard values of the standardized markers will be considered for the evaluations. |
| Effects of MRgFUS on the joint organ: bone turnover | Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12 | Enzyme linked immuno assays kits will be used to test bone turnover markers in serum. The reference standard values of the standardized markers will be considered for the evaluations. |
| Effects of MRgFUS on the joint organ: pain | Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12 | Enzyme linked immuno assays kits will be used to test pain markers in serum. The reference standard values of the standardized markers will be considered for the evaluations. |
| Effects of MRgFUS on the joint organ: cartilage turnover | Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12 | Enzyme linked immuno assays kits will be used to test cartilage turnover markers in urine. The reference standard values of the standardized markers will be considered for the evaluations. |
Countries
Italy
Outcome results
None listed