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Study of StimRouter for Chronic Knee OA Pain

NCT05644639 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2024-06-26

No results posted yet for this study

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)).

Conditions

  • Osteoarthritis, Knee

Interventions

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.

Sponsors & Collaborators

  • Bioventus LLC

    lead INDUSTRY

Principal Investigators

  • Stephen Mendelson, MD · Mendelson Kornblum Orthopedics

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2023-10-01
Completion
2024-06-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644639 on ClinicalTrials.gov