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MRgFUS in the Treatment of Osteoarthritic Knee Pain

Primary Purpose

Osteo Arthritis Knee, Osteoarthritis, Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MRgFUS Treatment
Placebo
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Osteoarthritis, Knee, MRgFUS, ExAblate, Pain, High-Intensity Focused Ultrasound Ablation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

MRgFUS treatment of pain caused by knee osteoarthritis

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 23, 2018
Last Updated
May 10, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03453372
Brief Title
MRgFUS in the Treatment of Osteoarthritic Knee Pain
Official Title
Pain in Knee Osteoarthritis, a Placebo-controlled Randomized Clinical Trial for a New Potential Therapeutic Approach: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
January 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Osteoarthritis, Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, MRgFUS, ExAblate, Pain, High-Intensity Focused Ultrasound Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind placebo-controlled randomized clinical trial
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
MRgFUS treatment of pain caused by knee osteoarthritis
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
Intervention Type
Device
Intervention Name(s)
MRgFUS Treatment
Intervention Description
Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
Primary Outcome Measure Information:
Title
Efficacy of MRgFUS in the treatment of pain caused by knee OA
Description
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
Secondary Outcome Measure Information:
Title
Effects of MRgFUS on the joint organ: inflammation
Description
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
Title
Effects of MRgFUS on the joint organ: bone turnover
Description
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
Title
Effects of MRgFUS on the joint organ: pain
Description
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
Title
Effects of MRgFUS on the joint organ: cartilage turnover
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Bazzocchi, MD, PhD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
State/Province
BO
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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MRgFUS in the Treatment of Osteoarthritic Knee Pain

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