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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
Underwent a primary or revision unilateral TKA
Must meet the definition of chronic pain.
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

Study Summary

This trial will test a new pain management system for people who just had knee surgery. The system will be used for 60 days and may help relieve pain in the operated knee.

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have completed the CHOIR questionnaire before and after TKA surgery.
Select...
You are 21 or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pain Intensity from Baseline to 12 Months
Secondary outcome measures
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
2,387 Previous Clinical Trials
17,334,050 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Regional Anesthesia & Pain MedicineJournal
Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Neuropathic Postamputation Pain: A Multicenter, Randomized, Placebo-controlled Trial
Gilmore, Christopher, Brian Ilfeld, Joshua Rosenow, Sean Li, Mehul Desai, Corey Hunter, Richard Rauck, et al.. 2019. “Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Neuropathic Postamputation Pain: A Multicenter, Randomized, Placebo-controlled Trial”. Regional Anesthesia & Pain Medicine. BMJ. doi:10.1136/rapm-2018-100109.
Neuromodulation: Technology at the Neural InterfaceJournal
Ultrasound-guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study
Ilfeld, Brian M., Engy T. Said, John J. Finneran IV, Jacklynn F. Sztain, Wendy B. Abramson, Rodney A. Gabriel, Bahareh Khatibi, et al.. 2019. “Ultrasound-guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study”. Neuromodulation: Technology at the Neural Interface. Elsevier BV. doi:10.1111/ner.12851.
Journal of Orthopaedic Surgery and ResearchJournal
Ultrasound-guided Percutaneous Peripheral Nerve Stimulation for Analgesia Following Total Knee Arthroplasty: A Prospective Feasibility Study
Ilfeld, Brian M., Christopher A. Gilmore, Stuart A. Grant, Michael P. Bolognesi, Daniel J. Del Gaizo, Amorn Wongsarnpigoon, and Joseph W. Boggs. 2017. “Ultrasound-guided Percutaneous Peripheral Nerve Stimulation for Analgesia Following Total Knee Arthroplasty: A Prospective Feasibility Study”. Journal of Orthopaedic Surgery and Research. Springer Science and Business Media LLC. doi:10.1186/s13018-016-0506-7.
Regional Anesthesia and Pain MedicineJournal
Ultrasound-guided Percutaneous Peripheral Nerve Stimulation
Ilfeld, Brian M., Rodney A Gabriel, Engy T. Said, Amanda M. Monahan, Jacklynn F. Sztain, Wendy B. Abramson, Bahareh Khatibi, et al.. 2018. “Ultrasound-guided Percutaneous Peripheral Nerve Stimulation”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1097/aap.0000000000000819.
~0 spots leftby Apr 2025
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