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MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

Primary Purpose

Osteoarthritis, Hip Osteoarthritis, Hand Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

MRgFUS treatment

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring MRgFUS, Pain, Hip, Trapeziometacarpal joint, Osteoarthritis

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hand ExAblate

Hip ExAblate

Arm Description

MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)

MRgFUS treatment of pain caused by hip OA

Outcomes

Primary Outcome Measures

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').

Incidence of Treatment-Related Adverse Events (Safety and Tolerability)

Collecting the number of treatment-related adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT03467165

First Posted

February 23, 2018

Last Updated

May 10, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT03467165

Brief Title

MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

April 27, 2019 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Hip Osteoarthritis, Hand Osteoarthritis

Keywords

MRgFUS, Pain, Hip, Trapeziometacarpal joint, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Pilot study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hand ExAblate

Arm Type

Experimental

Arm Description

MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)

Arm Title

Hip ExAblate

Arm Type

Experimental

Arm Description

MRgFUS treatment of pain caused by hip OA

Intervention Type

Device

Intervention Name(s)

MRgFUS treatment

Intervention Description

MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)

Intervention Type

Device

Intervention Name(s)

MRgFUS treatment

Intervention Description

MRgFUS treatment of pain caused by hip OA

Primary Outcome Measure Information:

Title

Changes in Pain Intensity from Baseline

Description

Time Frame

Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12

Title

Incidence of Treatment-Related Adverse Events (Safety and Tolerability)

Description

Collecting the number of treatment-related adverse events

Time Frame

Through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberto Bazzocchi, MD, PhD

Organizational Affiliation

The Rizzoli Ortopaedic Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

State/Province

ZIP/Postal Code

40136

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

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