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

NCT07178951 | Recruiting

• 1 other identifier: Knee-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis (OA) of the Knee; Knee Pain Arthritis; Chronic Knee Pain

Keywords

osteoarthritis; knee pain; focused ultrasound; nerve ablation

Outcome Measures

Primary Outcomes (2)

• 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..

  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.

  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

  Participants will have an MRI 5-7 days post treatment when feasible and not contraindicated

• Procedure time (in minutes)

  The time of the procedure will be documented in minutes.

• Radiation exposure (in seconds)

  The fluoroscopy time will be calculated and documented during the procedure.

• Periprocedural analgesic/sedative requirement

  During the procedure, analgesic/sedative use will be documented.

• Change in Pain Pressure Threshold (PPT) as measured on the tibial plateau.

  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

Study Arms (1)

Thermal ablation with Neurolyser XR

EXPERIMENTAL

Ablation of sensory nerves in the knee joint

Device: Neurotomy of the medial sensory articular branches

Interventions

Neurotomy of the medial sensory articular branches DEVICE

Non-invasive thermal ablation of the medial sensory articular branches of the knee joint

Also known as: Nerve ablation, genicular nerve ablation

Thermal ablation with Neurolyser XR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• FUSMobile Inc.: lead

Study Sites (1)

Unika Medical Centre

North York, Ontario, M3B3S6, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Melissa Diep Research Coordinator

CONTACT

647-740-0160 Canada; assistant@unikamed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: pilot, single center, prospective

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: September 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)