Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis

NCT ID
NCT07178951
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
FUSMobile Inc.
Conditions
Chronic Knee Pain, Knee Pain Arthritis, Osteoarthritis (OA) of the Knee

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Safety and Feasibility of the Neurolyser XR Device for the Treatment of Predominantly Medial Chronic Knee Pain Due to Osteoarthritis

Enrollment: 10 participants (Estimated).

What is being studied

  • Device: Neurotomy of the medial sensory articular branches

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Moderate to severe, predominantly medial chronic knee pain 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: 1. Individuals meeting any of the following criteria are not eligible for participation in this study: 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Canada

  • Ontario, Canada: 1

Sample of listed locations

  • Unika Medical Centre — North York, Ontario, M3J 0H1, Canada — Recruiting

Study details

Start date
September 9, 2026
Primary completion date
December 31, 2026
Completion date
March 30, 2027
First posted
September 17, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07178951
Registry last updated
September 17, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07178951 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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