Osteoarthritis (OA) of the KneeNCT07178951
Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
A study testing Neurotomy of the medial sensory articular branches in people with Osteoarthritis (OA) of the Knee and Knee Pain Arthritis, run by FUSMobile Inc. at 1 site in Canada.
Trial summary
This study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee. The sound waves are tightly focused on a specific area of the nerve. The sound waves cause a break in the nerve which carries pain signals. Sound waves transmit through the skin so there is no need for needles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Chronic Knee Pain
- What is being tested?
- Neurotomy of the medial sensory articular branches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2026to 30 Mar 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe, predominantly medial chronic knee pain
- Age adult >18 years old
- WOMAC Score of 30 or higher
- NRS>6 with ambulation
- Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)
- 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.
Who cannot join
- Individuals meeting any of the following criteria are not eligible for participation in this study:
- Individuals after any surgery associated with altered integrity of bone structure
- Individuals with severe pain in the second knee
- Individuals unable to understand and complete the research questionnaires in the official language
- 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
- Individuals with extensive scarring of the skin and tissue overlying the treatment area
Show all 15Show fewer
- Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
- Individuals with active inflammatory (e.g., rheumatoid) arthritis
- Individuals with concomitant mental health disorders, excluding compensated mood disorders
- Individuals with altered perception and processing of pain: Average NRS > 9, PCS>30, SSS-8 > 11, CSI>40 [46], [47], [48]
- Individuals with a first-degree family member already enrolled in this study
- Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors)
- Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions
- Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.
- Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Unika Medical Centre
North York, Ontario, M3J 0H1
Melissa Diep, Research Coordinator, 647-740-0160, assistant@unikamed.com
Michael Gofeld, MD
About this study
Official title: Safety and Feasibility of the Neurolyser XR Device for the Treatment of Predominantly Medial Chronic Knee Pain Due to Osteoarthritis
This study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee. The sound waves are tightly focused on a specific area of the nerve. The sound waves cause a break in the nerve which carries pain signals. Sound waves transmit through the skin so there is no need for needles. The procedure takes approximately one hour. The device has been approved in Health Canada and Europe for the treatment of lower back pain. This study is to evaluate the use of the same device for people in Canada who have knee pain related to osteoarthritis.
Read the detailed description
The research staff will provide a detailed description of the procedure to the study participant live, allowing time for the participant to ask questions. Once the participant agrees to be in the study, an informed consent form will be signed.
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.
- Being tested
- Neurotomy of the medial sensory articular branches
- Keywords
- osteoarthritis, knee pain, focused ultrasound, nerve ablation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotomy of the medial sensory articular branchesDevice
Also called Nerve ablation, genicular nerve ablation
Non-invasive thermal ablation of the medial sensory articular branches of the knee joint
| Study group | Role | What they receive |
|---|---|---|
| Thermal ablation with Neurolyser XR | Experimental | Ablation of sensory nerves in the knee joint Receives: Device: Neurotomy of the medial sensory articular branches |
What is being measured
The primary outcome is the main question the study is designed to answer.
A positive clinical outcome will be measured by a 2-point reduction in the Numerical Rating Score (NRS)
The NRS score is a 10 point scale, 0 to 10, with 0 meaning "no pain" and 10 meaning "worst possible pain"; the NRS score will be measured at baseline and all follow-up intervals - 2 days, 7 days, 1 month, 3 months, and 6 months..
Measured: Baseline score will be compared to post procedure intervals at 2 days, 7 days, 1 month, 3 months, and 6 months.
Safety will be measured by the incidence and severity of treatment-related adverse events.
Adverse events will be evaluated throughout the study.
Measured: Adverse events will be evaluated at baseline and post procedure - 2 days, 7 days, 1 month, 3 months, and 6 months.
Secondary outcomes (6)
Lesion size and location
Lesion size and location as shown in MRI images post treatment as available
Measured: Participants will have an MRI 5-7 days post treatment when feasible and not contraindicated
Procedure time (in minutes)
Procedure time will be documented from start to finish
Measured: The time of the procedure will be documented in minutes.
Radiation exposure (in seconds)
The procedure is completed using fluroscopy. The fluroscopy time is calculated by the C-Arm. This number will be documented.
Measured: The fluoroscopy time will be calculated and documented during the procedure.
Periprocedural analgesic/sedative requirement
Analgesic/sedatives used during the procedure will be documented.
Measured: During the procedure, analgesic/sedative use will be documented.
Change in Pain Pressure Threshold (PPT) as measured on the tibial plateau.
A pressure algometry device will be used to measure the pain pressure threshold throughout the study.
Measured: The PPT will be evaluated and documented at baseline and at follow-up intervals - 2 days, 7 days, 1 month, 3 months, and 6 months
Change in score Patient Global Impression of Change (PGIC)
The PGIC questionnaire will be given to participants during their onsite follow up visits.
Measured: PGIC questionnaires will be provided to participants 1 month, 3 months, and 6 months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start9 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- pilot, single center, prospective
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FUSMobile Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178951
- Sponsor's protocol ID
- Knee-001
- Status last verified
- Sep 2025
- First submitted
- 15 Jun 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study. If results are positive, we plan to organize a larger pivotal study.