MRgFUS in the Treatment of Osteoarthritic Knee Pain

NCT03453372 | Completed

• 1 other identifier: knee@IORFus
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Osteo Arthritis Knee; Osteoarthritis; Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee; MRgFUS; ExAblate; Pain; High-Intensity Focused Ultrasound Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Effects of MRgFUS on the joint organ: inflammation

  Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12

• Effects of MRgFUS on the joint organ: bone turnover

  Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12

• Effects of MRgFUS on the joint organ: pain

  Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12

• Effects of MRgFUS on the joint organ: cartilage turnover

  Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12

Study Arms (2)

Active

EXPERIMENTAL

MRgFUS treatment of pain caused by knee osteoarthritis

Device: MRgFUS Treatment

Placebo

PLACEBO COMPARATOR

Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.

Other: Placebo

Interventions

MRgFUS Treatment DEVICE

Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound

Active

Placebo OTHER

Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Bazzocchi, MD, PhD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind placebo-controlled randomized clinical trial

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 5, 2018
• Study Start: August 31, 2018
• Primary Completion: February 28, 2019
• Study Completion: January 12, 2020
• Last Updated: May 11, 2023

Record last verified: 2023-03

Locations

IT (1)