Osteo Arthritis KneeNCT03453372
MRgFUS in the Treatment of Osteoarthritic Knee Pain
A study testing MRgFUS Treatment in people with Osteo Arthritis Knee and Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused by knee osteoarthritis (OA) Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee, Osteoarthritis, Osteoarthritis, Knee
- What is being tested?
- MRgFUS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2018to 12 Jan 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged 50-80 years
- Activity-related joint pain
- Patients who have not responded to previous treatments and patients candidate for surgery
- Kellgren-Lawrence score 2-4 on X-rays
- Patients able to give their informed consent
Who cannot join
- Prior surgery in the past 12 months or previous local treatment in the past 3 months
- Changes in medications used during the previous 2 months
- Corticosteroid use for more than 3 months within the preceding year
- Rheumatologic and neurological disorders
- Fibromyalgia
- Trauma, fracture or osteomyelitis of the investigated joints within the preceding year
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- Pregnancy
- Patients with large scars potentially included in the ultrasound beam path
- General contraindications to MRI and/or to anaesthesiological procedures
- Presence of internal hardware or device potentially affecting MR thermometry
- Patients involved in other clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain in Knee Osteoarthritis, a Placebo-controlled Randomized Clinical Trial for a New Potential Therapeutic Approach: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS)
A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused by knee osteoarthritis (OA)
Read the detailed description
Osteoarthritis (OA) is a common, disabling, and costly disease, and the knee is one of the most affected joints. The predominant symptom is pain. Effective and lasting non-invasive treatment approaches are missing. MR-guided focused ultrasound surgery (MRgFUS) is a new minimally invasive technique which may represent a valid solution providing several advantages. The primary aim of this work will be to assess the efficacy of MRgFUS in the treatment of pain caused by knee OA in 80 patients candidate for arthroplasty in a prospective, randomized, double-blinded, placebo-controlled clinical trial. Different parameters related to pain, quality of life, function, and imaging will be collected and analyzed in a 12-month follow-up. The secondary aims will be focused on a) the evaluation of the effects on the joint organ and changes of biological features in response to MRgFUS, and b) the impact of selective ablation of nociceptors on OA pain, based on the analysis of resected joint tissues.
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Osteoarthritis, Knee
- Being tested
- MRgFUS Treatment, Placebo
- Keywords
- Osteoarthritis, Knee, MRgFUS, ExAblate, Pain, High-Intensity Focused Ultrasound Ablation
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgFUS TreatmentDevice
Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
PlaceboOther
Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | MRgFUS treatment of pain caused by knee osteoarthritis Receives: Device: MRgFUS Treatment |
| Placebo | Placebo comparator | Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of MRgFUS in the treatment of pain caused by knee OA
The efficacy of MRgFUS will be demonstrated if the treatment group has a mean reduction of Visual Analog Pain Scale (VAS) of at least 1.5 points greater than the control group.
Measured: Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12
Secondary outcomes (4)
Effects of MRgFUS on the joint organ: inflammation
Enzyme linked immuno assays kits will be used to test inflammatory markers in serum. The reference standard values of the standardized markers will be considered for the evaluations.
Measured: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: bone turnover
Enzyme linked immuno assays kits will be used to test bone turnover markers in serum. The reference standard values of the standardized markers will be considered for the evaluations.
Measured: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: pain
Enzyme linked immuno assays kits will be used to test pain markers in serum. The reference standard values of the standardized markers will be considered for the evaluations.
Measured: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: cartilage turnover
Enzyme linked immuno assays kits will be used to test cartilage turnover markers in urine. The reference standard values of the standardized markers will be considered for the evaluations.
Measured: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start31 Aug 2018
- Primary completion28 Feb 2019
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo-controlled randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453372
- Sponsor's protocol ID
- knee@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
- Pain in Knee Osteoarthritis, a Placebo-controlled Randomized Clinical Trial for a New Potential Therapeutic Approach: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS)
- ClinicalTrials.gov ID
- NCT03453372
- Acronym / sponsor ID
- knee@IORFus
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, MRgFUS, ExAblate, Pain, High-Intensity Focused Ultrasound Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 5 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.
A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused by knee osteoarthritis (OA)
Detailed description
Osteoarthritis (OA) is a common, disabling, and costly disease, and the knee is one of the most affected joints. The predominant symptom is pain. Effective and lasting non-invasive treatment approaches are missing. MR-guided focused ultrasound surgery (MRgFUS) is a new minimally invasive technique which may represent a valid solution providing several advantages. The primary aim of this work will be to assess the efficacy of MRgFUS in the treatment of pain caused by knee OA in 80 patients candidate for arthroplasty in a prospective, randomized, double-blinded, placebo-controlled clinical trial. Different parameters related to pain, quality of life, function, and imaging will be collected and analyzed in a 12-month follow-up. The secondary aims will be focused on a) the evaluation of the effects on the joint organ and changes of biological features in response to MRgFUS, and b) the impact of selective ablation of nociceptors on OA pain, based on the analysis of resected joint tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind placebo-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: MRgFUS TreatmentMRgFUS treatment of pain caused by knee osteoarthritis |
| Placebo | Placebo comparator | Other: PlaceboProcedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged 50-80 years
- Activity-related joint pain
- Patients who have not responded to previous treatments and patients candidate for surgery
- Kellgren-Lawrence score 2-4 on X-rays
- Patients able to give their informed consent
Key exclusion criteria (11 listed)
- Prior surgery in the past 12 months or previous local treatment in the past 3 months
- Changes in medications used during the previous 2 months
- Corticosteroid use for more than 3 months within the preceding year
- Rheumatologic and neurological disorders
- Fibromyalgia
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 TreatmentTreatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound | Device | Active |
| PlaceboProcedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used. | Other | Placebo |
Primary outcome
Efficacy of MRgFUS in the treatment of pain caused by knee OA
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12
The efficacy of MRgFUS will be demonstrated if the treatment group has a mean reduction of Visual Analog Pain Scale (VAS) of at least 1.5 points greater than the control group.
4 secondary outcomes
Effects of MRgFUS on the joint organ: inflammation
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: bone turnover
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: pain
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Effects of MRgFUS on the joint organ: cartilage turnover
Time frame: Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
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
Istituto Ortopedico Rizzoli
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 Osteo Arthritis Knee and 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 5 inclusion and 11 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. Some participants in this study may receive a placebo. 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?
Efficacy of MRgFUS in the treatment of pain caused by knee OA (time frame: Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12). 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.