OsteoarthritisNCT03467165
MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain
A study testing MRgFUS treatment in people with Osteoarthritis and Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Osteoarthritis, Hip Osteoarthritis, Hand Osteoarthritis
- What is being tested?
- MRgFUS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2019to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints
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.
Read the 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
- Osteoarthritis, Hip Osteoarthritis, Hand Osteoarthritis
- Being tested
- MRgFUS treatment
- Keywords
- MRgFUS, Pain, Hip, Trapeziometacarpal joint, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgFUS treatmentDevice
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
MRgFUS treatmentDevice
MRgFUS treatment of pain caused by hip OA
| Study group | Role | What they receive |
|---|---|---|
| Hand ExAblate | Experimental | MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA) Receives: Device: MRgFUS treatment |
| Hip ExAblate | Experimental | MRgFUS treatment of pain caused by hip OA Receives: Device: MRgFUS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start27 Apr 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Bazzocchi, MD, PhD, Principal investigator, The Rizzoli Ortopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467165
- Sponsor's protocol ID
- handhip@IORFus
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2018
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints
- ClinicalTrials.gov ID
- NCT03467165
- Acronym / sponsor ID
- handhip@IORFus
- Conditions
- Osteoarthritis, Hip Osteoarthritis, Hand Osteoarthritis
- Keywords
- MRgFUS, Pain, Hip, Trapeziometacarpal joint, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 27 Apr 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Hand ExAblate | Experimental | Device: MRgFUS treatmentMRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA) |
| Hip ExAblate | Experimental | Device: MRgFUS treatmentMRgFUS treatment of pain caused by hip OA |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRgFUS treatmentMRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA) | Device | Hand ExAblate |
| MRgFUS treatmentMRgFUS treatment of pain caused by hip OA | Device | Hip ExAblate |
Primary outcome
Changes in Pain Intensity from Baseline
Time frame: Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12
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)
Time frame: Through study completion, an average of 1 year
Collecting the number of treatment-related adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Bazzocchi, MD, PhD principal investigator
The Rizzoli Ortopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRgFUS treatment in people with Osteoarthritis and Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain Intensity from Baseline (time frame: Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.