Temporary Peripheral Nerve Stimulation System for Osteoar... | NCT06152029

Studies
Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

NCT06152029

Sponsor

Wake Forest University Health Sciences

Status

Terminated

Last Update Posted

Nov 6, 2025Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Osteoarthritis, Knee
Osteoarthritis

Interventions

Temporary PNS system

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
23.135E	Other Identifier	Aurora IRB

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator left Advocate Health

Expanded Access Info

Start Date

Nov 15, 2023Actual

Primary Completion Date

Oct 20, 2025Actual

Completion Date

Oct 20, 2025Actual

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 21, 2023

First Posted Date

Nov 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2025

Last Update Posted Date

Nov 6, 2025Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated with a temporary PNS system		These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis	Device: Temporary PNS system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temporary PNS system	Device	This system remains in place up to 60 days, then removed.	Patients treated with a temporary PNS system

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study population includes patients with chronic knee pain secondary to osteoarthritis of the knee and will receive a temporary peripheral nerve stimulation device.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Aurora Health Center		Fond du Lac	Wisconsin	54937	United States
Aurora Health Oshkosh

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis