Study of StimRouter for Chronic Knee OA Pain (GLEAM)

StimRouter Genicular NeuromoduLation for Chronic KnEe OsteoArthritic Pain Management

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:

1. To assess the effect of the StimRouter Neuromodulation System to manage joint pain in patients with symptomatic OA of the knee who are surgically contraindicated to undergo a knee joint arthroplasty
2. To assess the effect of StimRouter on joint stiffness, function and patient quality of life

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)).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: StimRouter Neuromodulation System

Detailed Description

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)).

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Livonia, Michigan, United States, 48154
      • Mendelson Kornblum Orthopedic and Spine Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Subject is at least 21 years of age at the time of giving informed consent
2. Radiographic disease Stage ≥ 1 in the target knee according to the Kellgren-Lawrence grading of knee OA
3. Knee joint arthroplasty procedure is contraindicated
4. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
5. Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

1. Subject has undergone previous joint arthroplasty procedure (partial, total, patella-femoral) to the index knee
2. Unresolved effusion of the target knee clinically requiring aspiration within 12 weeks prior to Visit 1 (Baseline)
3. Treatment of the index knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 6 weeks prior to Visit 1 (Baseline)
4. Visco-supplementation (e.g., hyaluronic acid) in the index knee within 6 weeks prior to Visit 1 (Baseline)
5. Subject has an active systemic infection or an active local infection in or near the index knee joint, or has a previous history of joint infection.
6. Subject with bleeding disorders or active anticoagulation that cannot be stopped for a few days prior to the time of the surgical procedure.
7. Subject who has an active or existing skin disorder or irritation, which, in the opinion of the Investigator, precludes the use of skin gel electrodes.
8. Subjects has or plans to have a pacemaker, defibrillator, cochlear implant, and/or a sleep apnea implant.
9. Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
10. Subject who currently requires or is likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire PNS lead must be at least 50 cm from the center of the MRI system's bore (the iso-center) and at least 16 cm outside of the MRI coil measured from the edge of the MRI coil.
11. Female subject who is pregnant or nursing or plans to become pregnant during the study. The effects of electrical stimulation on pregnancy are not known. Do not use electrical stimulation (including StimRouter) during pregnancy.
12. Any condition and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
13. Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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.

Collaborators and Investigators

• Sponsor: Bioventus LLC
• Investigators: Principal Investigator: Stephen Mendelson, MD, Mendelson Kornblum Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee Pain; Neuromodulation; StimRouter
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PNS-22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No