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

NCT04670042 | Withdrawn FDA Device

• 1 other identifier: 58819
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Pain Following Left Total Knee Arthroplasty; Chronic Pain Following Right Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity from Baseline to 12 Months

  The primary outcome is Pain Intensity using Numerical Rating Scale (NRS) from 0-10 with the higher number (10) being worse pain and (0) being no pain. Incidence of chronic post-surgical pain (CPSP) through Pain Intensity will be looked at for patients throughout the study along with usage of the Peripheral Nerve Stimulation (PNS) device (hours/day). A collection of surveys already approved for patients following total knee arthroplasty from Stanford's Collaborative Health Outcomes Information Registry (CHOIR) will also be sent to patients.

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

Secondary Outcomes (1)

• Change in Opioid Use

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

Study Arms (1)

SPRINT® Peripheral Nerve Stimulation (PNS) System

EXPERIMENTAL

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.

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

Interventions

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

Same as Arm Description.

SPRINT® Peripheral Nerve Stimulation (PNS) System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 21 years old
• Underwent a primary or revision unilateral TKA
• Completed all CHOIR questionnaires before and after TKA surgery
• Persistent postsurgical knee pain ≥ 5 of 10 during ambulation as demonstrated on the CHOIR assessment.
• Must meet the definition of chronic pain.
• 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.

You may not qualify if:

• Patients with a pre-operative history of moderate to high dose use of opioids (≥ 50 morphine milligram equivalents (MME) average per day)
• Patients taking opioids for reasons other than pain in knee that underwent TKA
• Patients with arthrofibrosis or indicated for manipulation under anesthesia
• BMI \>35
• Uncontrolled Diabetes Mellitus Types I or II, indicated by an HbA1c \>7.0% within the last 3 months
• Vulnerable population (e.g. pregnant women, prisoners, minors, or employees)
• Deep brain stimulation (DBS) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the SPRINT stimulator's current pathway.
• Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage in affected leg, pain caused by knee implant requiring revision, compromised immune system) as determined by the Investigator
• Workers Compensation

Sponsors & Collaborators

• Stanford University: lead
• SPR Therapeutics, Inc.: collaborator

Study Sites (1)

Stanford Pain Management Center

Redwood City, California, 94063, United States

Location

Related Publications (5)

• Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.

  PMID: 30954936 BACKGROUND

• Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. 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. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.

  PMID: 30160335 BACKGROUND

• Ilfeld BM, Gabriel RA, Said ET, Monahan AM, Sztain JF, Abramson WB, Khatibi B, Finneran JJ 4th, Jaeger PT, Schwartz AK, Ahmed SS. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. Reg Anesth Pain Med. 2018 Aug;43(6):580-589. doi: 10.1097/AAP.0000000000000819.

  PMID: 29905630 BACKGROUND

• Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7.

  PMID: 28086940 BACKGROUND

• Ilfeld BM, Ball ST, Gabriel RA, Sztain JF, Monahan AM, Abramson WB, Khatibi B, Said ET, Parekh J, Grant SA, Wongsarnpigoon A, Boggs JW. A Feasibility Study of Percutaneous Peripheral Nerve Stimulation for the Treatment of Postoperative Pain Following Total Knee Arthroplasty. Neuromodulation. 2019 Jul;22(5):653-660. doi: 10.1111/ner.12790. Epub 2018 Jul 19.

  PMID: 30024078 BACKGROUND

Related Links

• Peripheral Nerve Stimulator Device Website

MeSH Terms

Conditions

Wounds and Injuries; Knee Injuries; Pain, Postoperative

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Einar Ottestad

  CLINICAL ASSOCIATE PROFESSOR, ANESTHESIOLOGY, PERIOPERATIVE AND PAIN MEDICINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Case series of 15 subjects with chronic post-surgical pain (CPSP). Subjects will be recruited over 6 months (on average 1 subject per week)

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 17, 2020
• Study Start: June 25, 2021
• Primary Completion: August 1, 2022
• Study Completion: May 1, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)