NCT05644639

Study of StimRouter for Chronic Knee OA Pain

StimRouter Genicular NeuromoduLation for Chronic KnEe OsteoArthritic Pain Management

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

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. 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)).

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

Interventions

Type	Name	Description
DEVICE	StimRouter Neuromodulation System	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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2023-10-01
• Completion: 2024-06-21
• First posted: 2022-12-09
• Last updated: 2024-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study