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MRgFUS in the Treatment of Osteoarthritic Knee Pain

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ClinicalTrials.gov Identifier: NCT03453372
Recruitment Status : Unknown
Verified March 2018 by Istituto Ortopedico Rizzoli.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Study Description
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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)

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Osteoarthritis Osteoarthritis, Knee Device: MRgFUS Treatment Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind placebo-controlled randomized clinical trial
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
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)
Estimated Study Start Date : August 31, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : January 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453372


Contacts
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Contact: Alberto Bazzocchi, MD, PhD +39 051 636 6836 abazzo@inwind.it
Contact: Daniele Mercatelli, PhD +39 051 636 6028 daniele.mercatelli@ior.it

Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Alberto Bazzocchi, MD, PhD Istituto Ortopedico Rizzoli
More Information
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03453372    
Other Study ID Numbers: knee@IORFus
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Istituto Ortopedico Rizzoli:
Osteoarthritis
Knee
MRgFUS
 ExAblate
Pain
High-Intensity Focused Ultrasound Ablation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases