WithdrawnNot Applicable

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

Stopped: Difficulty enrolling in this patient population

United States0Started 2021-06-25

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pain that continues or is expected to continue for longer than 3 months from its initial onset or
✓. Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or
✓. Pain requiring opioid use beyond 30 days.

What they're measuring

Change in Pain Intensity from Baseline to 12 Months

Timeframe: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA

Trial details

NCT IDNCT04670042

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08

View on ClinicalTrials.gov More Injury; Nerve, Peripheral, Multiple trials