MRgFUS in the Treatment of Osteoarthritic Knee Pain

Pain in Knee Osteoarthritis, a Placebo-controlled Randomized Clinical Trial for a New Potential Therapeutic Approach: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS)

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)

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Osteoarthritis, Knee; Osteo Arthritis Knee
• Intervention / Treatment: Device: MRgFUS Treatment; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; MRgFUS treatment of pain caused by knee osteoarthritis	Device: MRgFUS Treatment; Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
Placebo Comparator: Placebo; Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.	Other: Placebo; Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Alberto Bazzocchi, MD, PhD, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): January 12, 2020

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Knee; MRgFUS; ExAblate; High-Intensity Focused Ultrasound Ablation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: knee@IORFus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No