An interventional study of MRgFUS Treatment and Placebo in Osteo Arthritis Knee, Osteoarthritis and Osteoarthritis, Knee, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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)
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.
Exclusion Criteria:
MRgFUS treatment of pain caused by knee osteoarthritis
Device: MRgFUS Treatment
Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
Other: Placebo
Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
Efficacy of MRgFUS in the treatment of pain caused by knee OA
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.
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: inflammation
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.
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: bone turnover
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.
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: pain
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.
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: cartilage turnover
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.
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Plan to share: Undecided
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli