PNS for Knee Surgery Pain

Recruiting at10 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: SPR Therapeutics, Inc.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.

Research Team

Eligibility Criteria

This trial is for adults over 21 who've had a primary, secondary, or partial knee replacement and are experiencing pain from the surgery. It's not suitable for those with high opioid use, BMI over 40, electronic implants, bleeding/clotting disorders, pregnancy, risk of infection or uncontrolled diabetes.

Inclusion Criteria

I am at least 21 years old.

My knee pain is due to my knee replacement surgery.

I have had a knee replacement surgery.

Exclusion Criteria

You are currently using a lot of opioid medications.

You have a pacemaker or similar electronic device implanted in your body.

Pregnancy

Treatment Details

Interventions

• SPRINT Peripheral Nerve Stimulation (PNS) System (Device)

Trial Overview The study tests how well the SPRINT PNS System relieves post-operative knee pain by delivering small electrical currents to leg nerves. This device is FDA-cleared for managing acute and chronic pain in the back/extremities for up to 60 days.

Participant Groups

Group I: Group 1 (Treatment) Active Control 1 Intervention

Participants in Group 1 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Group II: Group 2 (Control) Placebo Group 1 Intervention

Participants in Group 2 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Participants will then have the option to crossover and receive stimulation therapy.

Who Is Running the Clinical Trial?

SPR Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

850+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences