Clinical trial NCT03453372: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Osteoarthritis
Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
MRgFUS
ExAblate
Pain
High-Intensity Focused Ultrasound Ablation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind placebo-controlled randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy of MRgFUS in the treatment of pain caused by knee OA
timeFrame: Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12
Secondary outcomes:
measure: Effects of MRgFUS on the joint organ: inflammation
timeFrame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
measure: Effects of MRgFUS on the joint organ: bone turnover
timeFrame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
measure: Effects of MRgFUS on the joint organ: pain
timeFrame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
measure: Effects of MRgFUS on the joint organ: cartilage turnover
timeFrame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Alberto Bazzocchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: