MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain | NCT03467165

Studies
MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

NCT03467165

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

May 11, 2023Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Osteoarthritis
Hip Osteoarthritis
Hand Osteoarthritis

Interventions

MRgFUS treatment
MRgFUS treatment

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2019Actual

Primary Completion Date

Mar 15, 2020Actual

Completion Date

Mar 15, 2021Actual

First Submitted Date

Feb 23, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2023

Last Update Posted Date

May 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hand ExAblate	Experimental	MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)	Device: MRgFUS treatment
Hip ExAblate	Experimental	MRgFUS treatment of pain caused by hip OA	Device: MRgFUS treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRgFUS treatment	Device	MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)	Hand ExAblate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alberto Bazzocchi, MD, PhD	The Rizzoli Ortopaedic Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Ortopedico Rizzoli		Bologna	BO	40136	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D015207	Osteoarthritis, Hip
D010146	Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided