Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
NCT ID: NCT07178951
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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Throughout the study, the research team will closely follow the participants health as it is related to their knee. The participant will have a physical exam of their knee and a pressure algometry test at each onsite visit. They will also rate their pain level on a numerical scale, provide a history of medications taken, and complete several quality of life questionnaires.
The participant will be asked to take their usual pain medication prior to the procedure. The study doctor may also provide additional medication depending on the study participants situation.
The study procedure will last approximately 1 hour. The procedure will take place using a standard X-ray device which allows the study doctor to see the structure of the knee and allow for location of the nerve causing knee pain.
The study device will use ultrasound waves to cause damage to the nerve of the knee where the pain is generated. The goal is to interrupt the pain signal pathway. The ultrasound waves go through the skin so no needles or incisions are needed.
It is unknown how much pain relief the participant will feel or how long it will last. The purpose of the study is to evaluate ten people who have the study procedure. If the study results are good, the manufacturer of the device plans to open up a larger study to involve more study participants.
For participants who have access and a MRI is not contraindicated, a follow-up MRI exam will be performed from day 5 to 7 of the participant's knee.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thermal ablation with Neurolyser XR
Ablation of sensory nerves in the knee joint
Neurotomy of the medial sensory articular branches
Non-invasive thermal ablation of the medial sensory articular branches of the knee joint
Interventions
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Neurotomy of the medial sensory articular branches
Non-invasive thermal ablation of the medial sensory articular branches of the knee joint
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age adult \>18 years old
3. WOMAC Score of 30 or higher
4. NRS\>6 with ambulation
5. Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)
6. Participants in whom the measured skin to bone depth is 2-6 cm using imaging ultrasound and ultrasound gel pad in the upper medial and lower medial joint capsule targets.
Exclusion Criteria
2. Individuals after any surgery associated with altered integrity of bone structure
3. Individuals with severe pain in the second knee
4. Individuals unable to understand and complete the research questionnaires in the official language
5. Individuals presenting with any severe medical condition preventing the participant from safely and effectively being treated in the study or reporting study outcomes, per PI decision
6. Individuals with extensive scarring of the skin and tissue overlying the treatment area
7. Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
8. Individuals with active inflammatory (e.g., rheumatoid) arthritis
9. Individuals with concomitant mental health disorders, excluding compensated mood disorders
10. Individuals with altered perception and processing of pain: Average NRS \> 9, PCS\>30, SSS-8 \> 11, CSI\>40 \[46\], \[47\], \[48\]
11. Individuals with a first-degree family member already enrolled in this study
12. Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors)
13. Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions
14. Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.
15. Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.
18 Years
ALL
No
Sponsors
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FUSMobile Inc.
INDUSTRY
Responsible Party
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Locations
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Unika Medical Centre
North York, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Knee-001
Identifier Type: -
Identifier Source: org_study_id
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