MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

Study Overview
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Brief Summary
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This project aims at performing a pilot study to provide data on safety and potential efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip OA, while exploring the potential application of MRgFUS to two different and central joints burdened by OA.

Detailed Description
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Pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social and economic burden. Global aging of the population is going to worsen the problem. The hand is the most affected site in the upper limb, and involvement of the trapeziometacarpal joint is highly prevalent, with significant limitation of functionality when it happens. In the lower limb, the hip and the knee share the leading position in the clinical scenario, with the former being historically the most frequently submitted to joint replacement. At any site, the vast majority of joint replacement surgery procedures are performed because of pain. MRgFUS has recently demonstrated a great potential in treating pain caused by different medical conditions, including osteoarthritis. The aim of the work is to study the feasibility, the safety and the potential efficacy of MRgFUS in treating pain from osteoarthritis in two hot spots: the hip and the trapeziometacarpal/scaphotrapezial joint.

Official Title
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Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints

Conditions
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Osteoarthritis, Hip Osteoarthritis, Hand Osteoarthritis

Intervention / Treatment
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* Device: MRgFUS treatment
* Device: MRgFUS treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged between 45 and 90 years Presence of activity-related joint pain Patients who have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes Patients who have not responded to previous treatments, Patients with a baseline pain intensity of 4 to 8 on a 10-cm VAS Patients who are not candidates for immediate surgery Signed statement of informed consent (approved by Ethics Committee) Exclusion Criteria: Prior surgery or previous local treatment (infiltration, other) in the past 3 months Changes in medications used during the previous 2 months Intravenous drug use Corticosteroid use of more than 3 months within the preceding year Diagnosis of other rheumatologic disorders Trauma, fracture, or osteomyelitis of the investigated joints within the preceding year Any neurological disease or disorders potentially affecting pain perception Fibromyalgia Pregnancy Patients with large scar at skin or deeper soft tissue potentially included in the planned path of the ultrasound beam General contraindications to MRI and/or to anaesthesiological procedures planned for the patient Presence of internal hardware or devices potentially affecting MR thermometry

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand ExAblate<br>MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA) | Device: MRgFUS treatment<br>* MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)<br>|
| Experimental: Hip ExAblate<br>MRgFUS treatment of pain caused by hip OA | Device: MRgFUS treatment<br>* MRgFUS treatment of pain caused by hip OA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Intensity from Baseline | Changes in pain intensity from baseline will be determined by a straight horizontal 10-cm linear Visual Analog Pain Scale (VAS, scale 0-10 where 0 means 'no pain at all' and 10 means 'pain as bad as it could be'). | Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12 | 
| Incidence of Treatment-Related Adverse Events (Safety and Tolerability) | Collecting the number of treatment-related adverse events | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRgFUS, Pain, Hip, Trapeziometacarpal joint, Osteoarthritis