Study of StimRouter for Chronic Knee OA Pain

NCT05644639 | Completed FDA Device

• 1 other identifier: PNS-22-01
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 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. 2.To assess the effect of StimRouter on joint stiffness, function and patient quality of life

Conditions

Osteoarthritis, Knee

Keywords

StimRouter; Osteoarthritis; Neuromodulation; Knee Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Serious Adverse Events (SAEs)

  The primary endpoint is at Month 3 post permanent implantation.

• Serious Adverse Events (SAEs)

  Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.

• Adverse Events (AEs)

  The primary endpoint is at Month 3 post permanent implantation.

• Adverse Events (AEs)

  Patients will continue to be followed up to Month 6 to gather additional efficacy and safety data.

• Secondary Interventions

  The primary endpoint is at Month 3 post permanent implantation.

Interventions

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.

Also known as: StimRouter

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Bioventus LLC: lead

Study Sites (1)

Mendelson Kornblum Orthopedic and Spine Specialists

Livonia, Michigan, 48154, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stephen Mendelson, MD

  Mendelson Kornblum Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 9, 2022
• Study Start: October 18, 2022
• Primary Completion: October 1, 2023
• Study Completion: June 21, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

US (1)