Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	21 Years - 90 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06152029
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mansoor Aman, MD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mansoor M Aman, MD
Principal Investigator Affiliation	Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee, Osteoarthritis

Arms & Interventions

Arms

: Patients treated with a temporary PNS system

These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis

Interventions

Device: - Temporary PNS system

This system remains in place up to 60 days, then removed.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora Health Center, Fond Du Lac, Wisconsin

Status

Recruiting

Address

Aurora Health Center

Fond Du Lac, Wisconsin, 54937

Site Contact

Merve Buluk Figueira, MS

[email protected]

920-456-1551

Aurora Health Oshkosh, Oshkosh, Wisconsin