Status:
COMPLETED
MRgFUS in the Treatment of Osteoarthritic Knee Pain
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Osteo Arthritis Knee
Osteoarthritis
Eligibility:
All Genders
50-80 years
Phase:
NA
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 osteoarthr...
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 approache...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03453372
Start Date
August 31 2018
End Date
January 12 2020
Last Update
May 11 2023
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136