Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery

Recruiting in Palo Alto (17 mi)

Overseen byEinar Ottestad

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses the SPRINT PNS System, a device that sends electrical signals to nerves, to help patients with knee pain after knee replacement surgery. The device aims to reduce pain by targeting specific nerves with electrical pulses. If needed, additional signals can be added for better pain relief. The SPRINT PNS System has been used to manage chronic postoperative knee pain by targeting specific nerves with electrical pulses.

Eligibility Criteria

Inclusion Criteria

You have persistent postsurgical knee pain ≥ 5 of 10 during ambulation as demonstrated on the CHOIR assessment.

Underwent a primary or revision unilateral TKA

You are 21 or older.

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Treatment Details

Interventions

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

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SPRINT® Peripheral Nerve Stimulation (PNS) SystemExperimental Treatment1 Intervention

SPRINT PNS System will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (TKA) who meet eligibility criteria and consistent with established coverage policy. SPRINT PNS System will be implanted for 60 days. At the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. If pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.