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

NCT04670042 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-20

No results posted yet for this study

Summary

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.

Conditions

  • Injury; Nerve, Peripheral, Multiple
  • Chronic Post-Procedural Pain
  • Total Knee Arthroplasty
  • Surgery
  • Knee Injuries
  • Knee Pain Chronic
  • Postoperative Pain
  • Chronic Postoperative Pain

Interventions

DEVICE

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

Same as Arm Description.

Sponsors & Collaborators

Principal Investigators

  • Einar Ottestad · CLINICAL ASSOCIATE PROFESSOR, ANESTHESIOLOGY, PERIOPERATIVE AND PAIN MEDICINE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2022-08-31
Completion
2024-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670042 on ClinicalTrials.gov