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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal ablation with Neurolyser XR | Experimental | Ablation of sensory nerves in the knee joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurotomy of the medial sensory articular branches | Device | Non-invasive thermal ablation of the medial sensory articular branches of the knee joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion size and location | Lesion size and location as shown in MRI images post treatment as available | Participants will have an MRI 5-7 days post treatment when feasible and not contraindicated |
| Procedure time (in minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Diep Research Coordinator | Contact | 647-740-0160 Canada | assistant@unikamed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unika Medical Centre | Recruiting | North York | Ontario | M3B3S6 | Canada |
This is a pilot study. If results are positive, we plan to organize a larger pivotal study.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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pilot, single center, prospective
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Procedure time will be documented from start to finish
| 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. | The fluoroscopy time will be calculated and documented during the procedure. |
| Periprocedural analgesic/sedative requirement | Analgesic/sedatives used during the procedure will be documented. | 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. | 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. | PGIC questionnaires will be provided to participants 1 month, 3 months, and 6 months post procedure. |