MRgFUS in the Treatment of Osteoarthritic Knee Pain

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee; Osteoarthritis, Knee; Osteoarthritis
• Interventions: Device: MRgFUS Treatment; Other: Placebo

• Registration Number: NCT03453372
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Study Start: 2018-08-31
• Primary Completion: 2019-02-28
• Study Completion: 2020-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	MRgFUS Treatment	MRgFUS treatment of pain caused by knee osteoarthritis
Placebo	Placebo	Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy