Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee
NCT ID: NCT06152029
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
12 participants
OBSERVATIONAL
2023-11-15
2025-10-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients treated with a temporary PNS system
These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis
Temporary PNS system
This system remains in place up to 60 days, then removed.
Interventions
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Temporary PNS system
This system remains in place up to 60 days, then removed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Littlefield Lauren, MD
Role: PRINCIPAL_INVESTIGATOR
Aurora Medical Center Oshkosh - 855 N Westhaven Dr
Locations
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Aurora Health Center
Fond du Lac, Wisconsin, United States
Aurora Health Oshkosh
Oshkosh, Wisconsin, United States
Countries
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Other Identifiers
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23.135E
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00104845
Identifier Type: -
Identifier Source: org_study_id