MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

Istituto Ortopedico Rizzoli

Status

Completed

Conditions

Osteoarthritis

Hip Osteoarthritis

Hand Osteoarthritis

Treatments

Device: MRgFUS treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03467165

handhip@IORFus

Details and patient eligibility

About

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.

Full description

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.

Enrollment

14 patients

Sex

All

Ages

45 to 90 years old

Volunteers

No Healthy Volunteers

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