Osteoarthritis, KneeGLEAMNCT05644639
Study of StimRouter for Chronic Knee OA Pain
An observational study of Osteoarthritis, Knee, run by Bioventus LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- StimRouter Neuromodulation System
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Subject is at least 21 years of age at the time of giving informed consent
- Radiographic disease Stage ≥ 1 in the target knee according to the Kellgren-Lawrence grading of knee OA
- Knee joint arthroplasty procedure is contraindicated
- Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
- Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Who cannot join
- Subject has undergone previous joint arthroplasty procedure (partial, total, patella-femoral) to the index knee
- Unresolved effusion of the target knee clinically requiring aspiration within 12 weeks prior to Visit 1 (Baseline)
- Treatment of the index knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 6 weeks prior to Visit 1 (Baseline)
- Visco-supplementation (e.g., hyaluronic acid) in the index knee within 6 weeks prior to Visit 1 (Baseline)
- 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.
- Subject with bleeding disorders or active anticoagulation that cannot be stopped for a few days prior to the time of the surgical procedure.
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- 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.
- Subjects has or plans to have a pacemaker, defibrillator, cochlear implant, and/or a sleep apnea implant.
- 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.
- 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.
- 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.
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mendelson Kornblum Orthopedic and Spine Specialists
Livonia, Michigan, 48154
About this study
Official title: 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:
- 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
- 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)).
Read the 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)).
- Conditions
- Osteoarthritis, Knee
- Being tested
- StimRouter Neuromodulation System
- Keywords
- StimRouter, Osteoarthritis, Neuromodulation, Knee Pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimRouter Neuromodulation SystemDevice
Also called StimRouter
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain
Change in pain with a Numeric Rating Scale (minimum 0 and maximum 10) from Baseline to 3 months after treatment
Measured: 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.
Measured: The primary endpoint is at Month 3 post permanent implantation.
Secondary outcomes (18)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start18 Oct 2022
- Primary completion1 Oct 2023
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Mendelson, MD, Principal investigator, Mendelson Kornblum Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644639
- Sponsor's protocol ID
- PNS-22-01
- Acronym
- GLEAM
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StimRouter Genicular NeuromoduLation for Chronic KnEe OsteoArthritic Pain Management
- ClinicalTrials.gov ID
- NCT05644639
- Acronym / sponsor ID
- GLEAM / PNS-22-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- StimRouter, Osteoarthritis, Neuromodulation, Knee Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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)).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Subject is at least 21 years of age at the time of giving informed consent
- Radiographic disease Stage ≥ 1 in the target knee according to the Kellgren-Lawrence grading of knee OA
- Knee joint arthroplasty procedure is contraindicated
- Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
- Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Key exclusion criteria (13 listed)
- Subject has undergone previous joint arthroplasty procedure (partial, total, patella-femoral) to the index knee
- Unresolved effusion of the target knee clinically requiring aspiration within 12 weeks prior to Visit 1 (Baseline)
- Treatment of the index knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 6 weeks prior to Visit 1 (Baseline)
- Visco-supplementation (e.g., hyaluronic acid) in the index knee within 6 weeks prior to Visit 1 (Baseline)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimRouter Neuromodulation SystemAlso: StimRouterThe 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. | Device | – |
Primary outcome
Knee Pain
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Change in pain with a Numeric Rating Scale (minimum 0 and maximum 10) from Baseline to 3 months after treatment
Knee Pain
Time frame: The primary endpoint is at Month 3 post permanent implantation.
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.
18 secondary outcomes
Serious Adverse Events (SAEs)
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Serious Adverse Events (SAEs)
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Adverse Events (AEs)
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Adverse Events (AEs)
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Secondary Interventions
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Secondary Interventions
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Knee Pain
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Knee Health
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Pain Experience
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Pain Experience
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Treatment Satisfaction Scores
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Forgotten Joint Score (FJS)
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Forgotten Joint Score (FJS)
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Health-Related Quality of Life (HRQOL)
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Health-Related Quality of Life (HRQOL)
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Treatment Satisfaction Scores
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Treatment Expectation Scores
Time frame: The primary endpoint is at Month 3 post permanent implantation.
Treatment Expectation Scores
Time frame: Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Mendelson, MD principal investigator
Mendelson Kornblum Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Bioventus LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (time frame: The primary endpoint is at Month 3 post permanent implantation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.