Clinical Trials Directory

Trials / Completed

CompletedNCT03467165

MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Istituto Ortopedico Rizzoli · Academic / Other
Sex
All
Age
45 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICEMRgFUS treatmentMRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
DEVICEMRgFUS treatmentMRgFUS treatment of pain caused by hip OA

Timeline

Start date
2019-04-27
Primary completion
2020-03-15
Completion
2021-03-15
First posted
2018-03-15
Last updated
2023-05-11

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03467165. Inclusion in this directory is not an endorsement.