Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients With Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee, Osteoarthritis

Intervention / Treatment
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* Device: Temporary PNS system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with a temporary PNS system<br>These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis | Device: Temporary PNS system<br>* This system remains in place up to 60 days, then removed.<br>* Other names: SPRINT PNS System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5. |  | up to 60 days post lead placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29. |  | up to 60 days post lead placement | 
| Average change from baseline to end of treatment in pain interference measured through BPI-SF. |  | up to 60 days post lead placement | 
| Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME) |  | up to 60 days post lead placement | 
| Overall patient global impression of change (PGIC) at end of treatment. |  | up to 60 days post lead placement | 
| Overall incidence of lead migration/fracture at the end of treatment. |  | up to 60 days post lead placement | 
| Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5. |  | 7 and 30 days post lead placement; and 6 and 12 month post lead pull | 
| Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29. |  | 7 and 30 days post lead placement; and 6 and 12 month post lead pull | 
| Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF. |  | 7 and 30 days post lead placement; and 6 and 12 month post lead pull | 
| Overall patient global impression of change (PGIC) at 6 months and end of study. |  | 6 and 12 months post lead pull | 
| Overall incidence of lead migration/fracture during the study. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral nerve stimulation, PNS