Status:
TERMINATED
Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Osteoarthritis, Knee
Osteoarthritis
Eligibility:
All Genders
21+ years
Brief Summary
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 20 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06152029
Start Date
November 15 2023
End Date
October 20 2025
Last Update
November 6 2025
Active Locations (2)
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1
Aurora Health Center
Fond du Lac, Wisconsin, United States, 54937
2
Aurora Health Oshkosh
Oshkosh, Wisconsin, United States, 54914