MRgFUS in the Treatment of Osteoarthritic Knee Pain

May 10, 2023 updated by: Istituto Ortopedico Rizzoli

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alberto Bazzocchi, MD, PhD
  • Phone Number: +39 051 636 6836
  • Email: abazzo@inwind.it

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of MRgFUS in the treatment of pain caused by knee OA
Time Frame: 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.
Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effects of MRgFUS on the joint organ: inflammation
Time Frame: 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.
Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: bone turnover
Time Frame: 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.
Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: pain
Time Frame: 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.
Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: cartilage turnover
Time Frame: 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.
Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alberto Bazzocchi, MD, PhD, Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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