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Device

SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) for Postoperative 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

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
  • Postoperative Pain
  • Chronic Knee Pain
  • Post-Procedural Pain
  • Peripheral Nerve Injury
  • Knee Injuries
  • Total Knee Replacement
  • Surgery

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
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

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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,394 Total Patients Enrolled
6 Trials studying Postoperative Pain
1,042 Patients Enrolled for Postoperative Pain
SPR Therapeutics, Inc.Industry Sponsor
11 Previous Clinical Trials
775 Total Patients Enrolled
3 Trials studying Postoperative Pain
127 Patients Enrolled for Postoperative Pain
Einar OttestadPrincipal Investigator - CLINICAL ASSOCIATE PROFESSOR, ANESTHESIOLOGY, PERIOPERATIVE AND PAIN MEDICINE
Baylor College Of Medicine (Medical School)
Stanford University Hospital (Residency)
~0 spots leftby Sep 2025
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