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Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System

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ClinicalTrials.gov Identifier: NCT03286543
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

Brief Summary:
The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard of care, alone. This study involves a device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator). About half the subjects in this study will receive the SPRINT Beta system (treatment group) and half will not (control group). Both groups will receive the standard of care.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Total Knee Arthroplasty Pain Postoperative Pain Orthopedic Disorder Device: SPRINT Beta System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Half of the subjects enrolled will be randomized (like flipping a coin) to the treatment group and half will be randomized to the control group. Both groups will receive the standard of care for pain management following total knee replacement surgery. Subjects in the treatment group will receive SPR's SPRINT Beta Peripheral Nerve Stimulation (PNS) System in addition to standard of care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Comparative Effectiveness Randomized Controlled Trial of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Treatment Group (SPRINT Beta System)
Subjects in the treatment group will have up to 2 leads placed in their leg that underwent total knee replacement, will use the SPRINT Beta System, and will receive electrical stimulation in addition to the standard of care.
Device: SPRINT Beta System
The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT Beta System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator).
Other Names:
  • SPRINT Beta Peripheral Nerve Stimulation (PNS) System
  • SPRINT Peripheral Nerve Stimulation (PNS) System
  • SPRINT System

No Intervention: Control Group
Subjects in the control group will receive the standard of care.



Primary Outcome Measures :
  1. Average knee pain while walking as measured by the Brief Pain Inventory [ Time Frame: Postoperative Day 0 to 28 (first 4 weeks following TKA) ]
  2. Device-related Adverse Events [ Time Frame: Before TKA (0-14 days) ]
  3. Device-related Adverse Events [ Time Frame: Day of TKA ]
  4. Device-related Adverse Events [ Time Frame: Daily for the duration of hospital stay, which is expected to be 1-2 days ]
  5. Device-related Adverse Events [ Time Frame: 1-week post TKA ]
  6. Device-related Adverse Events [ Time Frame: 2-weeks post-TKA ]
  7. Device-related Adverse Events [ Time Frame: 3-weeks post-TKA ]
  8. Device-related Adverse Events [ Time Frame: 4-weeks post-TKA ]
  9. Device-related Adverse Events [ Time Frame: 2-months post-TKA ]
  10. Device-related Adverse Events [ Time Frame: 3-months post-TKA ]
  11. Device-related Adverse Events [ Time Frame: 12-months post-TKA ]

Secondary Outcome Measures :
  1. Average knee pain as measured by the Brief Pain Inventory [ Time Frame: Postoperative Day 0 to 28 (first 4 weeks following TKA) ]
  2. Average knee pain at rest as measured by the Brief Pain Inventory [ Time Frame: Postoperative Day 0 to 28 (first 4 weeks following TKA) ]
  3. Pain right now as measured by the Brief Pain Inventory [ Time Frame: Before TKA (0-14 days),Day of TKA,Daily for the duration of hospital stay which is expected to be 1-2 days, 2-weeks post TKA, 4-weeks post TKA ]
  4. Cumulative analgesic usage [ Time Frame: Baseline, Before TKA (0-14 days), Day of TKA,Daily for the duration of hospital stay which is expected to be 1-2 days, 1-week post TKA, 2-weeks post-TKA, 3-weeks post-TKA, 4-weeks post-TKA, 2-months post-TKA, 3-months post-TKA, 12-months post-TKA ]
  5. Opioid-Related side effects [ Time Frame: 0-14 days before TKA, Daily for the duration of hospital stay which is expected to be 1-2 days, 1 week post-TKA, 2 weeks post-TKA, 3 weeks post-TKA, 4 weeks post-TKA, 2 months post-TKA, 3 months post-TKA, 12 months post-TKA ]
  6. Timed Up and Go Test [ Time Frame: Baseline, Daily for the duration of hospital stay which is expected to be 1-2 days, 2 weeks post-TKA, 4 weeks post-TKA ]
  7. Six Minute Walk Test [ Time Frame: Baseline, 2 weeks post-TKA, 4 weeks post-TKA ]
  8. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 2 weeks post-TKA, 4 weeks post-TKA, 3 months post-TKA, 12 months post-TKA ]
  9. Patient Global Impression of Change (PGIC) [ Time Frame: Day of TKA, Daily for the duration of hospital stay which is expected to be 1-2 days, 1 week post-TKA, 2 weeks post-TKA, 3 weeks post-TKA, 4 weeks post-TKA, 2 months post-TKA, 3 months post-TKA ]
  10. Pain Catastrophizing Scale [ Time Frame: Baseline, 4 weeks post-TKA, 3 months post-TKA ]
  11. Time to Recovery Milestones [ Time Frame: Daily for the duration of hospital stay which is expected to be 1-2 days, 1 week post-TKA, 2 weeks post-TKA, 3 weeks post-TKA, 4 weeks post-TKA, 2 months post-TKA, 3 months post-TKA ]
  12. Subject Satisfaction Survey [ Time Frame: 4 weeks post-TKA ]
  13. Inpatient Pain Management Experience Survey [ Time Frame: 1 week post-TKA ]
  14. Number of Physical Therapy Sessions [ Time Frame: 1 week post-TKA, 2 weeks post-TKA, 3 weeks post-TKA, 4 weeks post-TKA, 2 months post-TKA, 3 months post-TKA ]
  15. Subject's Use of Device Compliance [ Time Frame: Daily for the duration of hospital stay which is expected to be 1-2 days, 2 weeks post-TKA, 4 weeks post-TKA ]
    Treatment Group only



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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Scheduled to undergo a primary unilateral total knee replacement procedure

Key Exclusion Criteria:

  • Body Mass Index > 40 kg/m2
  • Conditions that place the subject at increased risk of infection
  • History of valvular heart disease
  • Implanted electronic device
  • Bleeding disorder
  • Allergy to skin surface electrodes and/or medical-grade adhesive tapes
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286543


Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Jesal Parekh, PhD    858-822-1288    jeparekh@ucsd.edu   
Principal Investigator: Brian Ilfeld, MD, MS         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 22710
Contact: Ashley Burke    919-681-2849    ashley.burke@duke.edu   
Principal Investigator: Stuart Grant, MB, ChB         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ahmed Salih, MD    216-636-1146    saliha2@ccf.org   
Principal Investigator: Hesham Elsharkawy, MD         
Joint Implant Surgeons Recruiting
New Albany, Ohio, United States, 43054
Contact: Michael Sneller    614-221-6331 ext 347    SnellerMA@joint-surgeons.com   
Principal Investigator: Keith Berend, MD         
United States, Texas
HD Research Recruiting
Houston, Texas, United States, 77004
Contact: Lauren Howard    281-770-5752    lauren@researchhd.com   
Principal Investigator: Daneshvari Solanki, MD         
Sponsors and Collaborators
SPR Therapeutics, Inc.

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Responsible Party: SPR Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03286543     History of Changes
Other Study ID Numbers: 0144-CSP-000
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by SPR Therapeutics, Inc.:
electrical stimulation
neurostimulation
TKA pain
pain following total knee replacement
total knee arthroplasty

Additional relevant MeSH terms:
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Pain, Postoperative
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms