SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) for Chronic Knee Pain

N/A

Waitlist Available

Led By Einar Ottestad

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Chronic Knee Pain
Knee Injuries
Postoperative Pain
Chronic Pain
Peripheral Neuropathy
Post-Procedural Pain
Total Knee Replacement
Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Intensity from Baseline to 12 Months

Secondary study objectives

Change in Opioid Use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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