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The goal of this study is to evaluate the use of StimRouter Neuromodulation System (StimRouter) in adult subjects with an established diagnosis of primary femorotibial osteoarthritis in the target knee (Kellgren-Lawrence ≥1) who have surgical contraindications to undergo a knee joint arthroplasty procedure. The main questions it aims to answer are:
Participants will have StimRouter leads implanted then clinic visits will be scheduled for follow-up at Week 2, Month 3 and Month 6 (End of Study (EOS) or Early Termination (ET)).
This study will be a single-center, single-arm, open label pilot study evaluating the safety and efficacy of the StimRouter Neuromodulation System as a peripheral nerve stimulator targeting knee joint innervation of moderately to severely symptomatic subjects with OA of the knee who are non-eligible to undergo a joint arthroplasty at the target knee.
Up to 30 subjects will be enrolled and participate in the study. Clinic visits will be scheduled at Screening, Stimulation Trial Procedure, Trial Assessment Visit, Implant Procedure and Follow-up Week 2, Month 3 and Month 6 (End of Study (EOS) or Early Termination (ET)).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimRouter Neuromodulation System | Device | The StimRouter device is indicated for pain management in adults who have severe, intractable chronic pain of peripheral nerve origin and as an adjunct to other modes of therapy (e.g., medications). The StimRouter device is not intended to treat pain of craniofacial nerve origin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Pain | Change in pain with a Numeric Rating Scale (minimum 0 and maximum 10) from Baseline to 3 months after treatment | The primary endpoint is at Month 3 post permanent implantation. |
| Knee Pain | Change in pain from Baseline to Month 3 in knee health as assessed by the KOOS-12 questionnaire. The KOOS-12 questionnaire is a 12-item measure derived from the original 42 item Knee injury and Ostoearthritis Outcome Score (KOOS). KOOS-12 contains 4 KOOS Pain items, 4 KOOS Function (Activities of Daily Living and Sport/Recreation) items, and 4 KOOS Quality of Life (QOL) items. | The primary endpoint is at Month 3 post permanent implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events (SAEs) | Frequency and proportion of device, or procedure-related Serious Adverse Events (SAEs) in subjects who receive permanent implant of the StimRouter Neuromodulation System | The primary endpoint is at Month 3 post permanent implantation. |
| Serious Adverse Events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with an established diagnosis of primary femorotibial OA in the target knee (Kellgren-Lawrence ≥1) who have surgical contraindications to undergo a knee joint arthroplasty procedure
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Mendelson, MD | Mendelson Kornblum Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mendelson Kornblum Orthopedic and Spine Specialists | Livonia | Michigan | 48154 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Frequency and proportion of device, or procedure-related Serious Adverse Events (SAEs) in subjects who receive permanent implant of the StimRouter Neuromodulation System |
| Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Adverse Events (AEs) | Frequency and proportion of device, or procedure-related non-serious adverse events (AEs) in subjects who receive permanent implant of the StimRouter Neuromodulation System | The primary endpoint is at Month 3 post permanent implantation. |
| Adverse Events (AEs) | Frequency and proportion of device, or procedure-related non-serious adverse events (AEs) in subjects who receive permanent implant of the StimRouter Neuromodulation System | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Secondary Interventions | Rate of secondary interventions (e.g. surgical or intra-articular injection) to the index knee | The primary endpoint is at Month 3 post permanent implantation. |
| Secondary Interventions | Rate of secondary interventions (e.g. surgical or intra-articular injection) to the index knee | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Knee Pain | Change in pain with a Numeric Rating Scale (minimum 0 and maximum 10) from Baseline to 6 months after treatment | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Knee Health | Change in pain from Baseline to Month 6 in knee health as assessed by the KOOS-12 questionnaire. The KOOS-12 questionnaire is a 12-item measure derived from the original 42 item Knee injury and Ostoearthritis Outcome Score (KOOS). KOOS-12 contains 4 KOOS Pain items, 4 KOOS Function (Activities of Daily Living and Sport/Recreation) items, and 4 KOOS Quality of Life (QOL) items. | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Pain Experience | the change from baseline to Month 3 in pain experience (pain catastrophizing) as assessed by the PCS questionnaire scale score. | The primary endpoint is at Month 3 post permanent implantation. |
| Pain Experience | the change from baseline to Month 6 in pain experience (pain catastrophizing) as assessed by the PCS questionnaire scale score | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Treatment Satisfaction Scores | Treatment Satisfaction is measured using a 5 question questionnaire with answers ranging from "Very Satisfied" to "Very Dissatisfied" | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Forgotten Joint Score (FJS) | The FJS-12 Questionnaire comprises measures for assessment of joint-specific patient reported outcomes that focuses on subject's awareness of affected joint in everyday life. Joint awareness defined as any unintended perception of a joint. Subjects rate awareness of their knee joint in 12 questions with a 5-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". Scores are summed & linearly transformed in a 0-100 scale with a high value reflecting subject's ability to forget the affected knee joint during daily living activities. | The primary endpoint is at Month 3 post permanent implantation. |
| Forgotten Joint Score (FJS) | The FJS-12 Questionnaire comprises measures for assessment of joint-specific patient reported outcomes that focuses on subject's awareness of affected joint in everyday life. Joint awareness defined as any unintended perception of a joint. Subjects rate awareness of their knee joint in 12 questions with a 5-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". Scores are summed & linearly transformed in a 0-100 scale with a high value reflecting subject's ability to forget the affected knee joint during daily living activities. | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Health-Related Quality of Life (HRQOL) | the change from baseline to Month 3 in Health-Related Quality of Life (HRQOL) as assessed by the PROMIS-10 Global Health questionnaire. The PROMIS-10 is a 10 question questionnaire with answers ranging from "Excellent" to "Poor" | The primary endpoint is at Month 3 post permanent implantation. |
| Health-Related Quality of Life (HRQOL) | the change from baseline to Month 6 in Health-Related Quality of Life (HRQOL) as assessed by the PROMIS-10 Global Health questionnaire. The PROMIS-10 is a 10 question questionnaire with answers ranging from "Excellent" to "Poor" | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |
| Treatment Satisfaction Scores | Treatment Satisfaction is measured using a 5 question questionnaire with answers ranging from "Very Satisfied" to "Very Dissatisfied" | The primary endpoint is at Month 3 post permanent implantation. |
| Treatment Expectation Scores | Treatment Expectation is measured using a 3 question questionnaire with subjects assessing their expectations of treatment ranging from "Too Low - I'm a lot better than I thought" to "Too High - I'm somewhat worse than I thought" | The primary endpoint is at Month 3 post permanent implantation. |
| Treatment Expectation Scores | Treatment Expectation is measured using a 3 question questionnaire with subjects assessing their expectations of treatment ranging from "Too Low - I'm a lot better than I thought" to "Too High - I'm somewhat worse than I thought" | Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data. |