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Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Recruiting
21 - 90 years of age
Both
Phase N/A

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Overview

The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.

Eligibility

Inclusion Criteria:

  • Age of 21 and older
  • Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis
  • Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
  • Be willing and capable of giving informed consent
  • Be willing and able to comply with study-related requirements, procedures, and scheduled visits

Exclusion Criteria:

  • No knee pain at rest
  • Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable
  • Pregnancy
  • History of repetitive skin infections
  • Vulnerable populations (e.g., prisoners, minors, students, employees)
  • Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled diabetes)
  • Confounding conditions such as lumbar radiculopathy
  • Deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the SPRINT system.
  • Be involved in an injury claim under current litigation
  • Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
  • Have a pending or approved worker's compensation claim

Study details

Osteoarthritis, Knee, Osteoarthritis

NCT06152029

Mansoor Aman, MD

25 January 2024

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