NCT03467165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 27, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

May 11, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

February 23, 2018

Last Update Submit

May 10, 2023

Conditions

OsteoarthritisHip OsteoarthritisHand Osteoarthritis

Keywords

MRgFUSPainHipTrapeziometacarpal jointOsteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

MRgFUS treatmentDEVICE

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

Hand ExAblate

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, HipPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alberto Bazzocchi, MD, PhD

    The Rizzoli Ortopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 15, 2018

Study Start

April 27, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2021

Last Updated

May 11, 2023

Record last verified: 2023-03

Locations

IT(1)