Clinical trial NCT03286543: Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Total Knee Arthroplasty
Pain
Postoperative Pain
Orthopedic Disorder
Keywords: electrical stimulation
neurostimulation
TKA pain
pain following total knee replacement
total knee arthroplasty
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Average Knee Pain While Walking
timeFrame: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)
measure: Number of Subjects That Experienced at Least One Study-Related Adverse Event
timeFrame: 30 months (from when the first Treatment Group subject enrolled to when the last Treatment Group subject completed the study)
Secondary outcomes:
measure: Average Knee Pain Over the Last 24 Hours
timeFrame: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
measure: Average Knee Pain at Rest
timeFrame: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
measure: Pain Right Now as Measured by the Brief Pain Inventory
timeFrame: Baseline (Visit 2a/2b), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 4 (in-hospital), Visit 6 (2-weeks post TKA), and Visit 8 (4-weeks post TKA)
measure: Amount of Analgesic Usage
timeFrame: Visits 5-8 (weeks 1-4 post-Total Knee Arthroplasty (TKA))
measure: Number of Subjects That Experienced at Least One Opioid-Related Side Effect
timeFrame: Baseline (Visit 2a/2b), Visits 4-11 (in-hospital days through 12-months post-Total Knee Arthroplasty (TKA))
measure: Timed Up and Go (TUG) Test
timeFrame: Visit 1 (Baseline), Visit 4 (In-Hospital), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks Post-TKA)
measure: Six Minute Walk Test (6MWT)
timeFrame: Visit 1 (Baseline), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks post-TKA)
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Visit 1 (Baseline), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 10 (3-months post-TKA), and Visit 11 (12-months post-TKA)
measure: Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
timeFrame: Visits 3-11 (Day of Total Knee Arthroplasty (TKA) through 12-months post-TKA)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Visit 1 (Baseline), Visit 8 (4 weeks post-Total Knee Arthroplasty (TKA)), Visit 10 (3-months Post-TKA)
measure: Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA)
timeFrame: From Day of Surgery through completion of milestone or 12-months from Day of Surgery, whichever came first
measure: Subject Satisfaction Survey
timeFrame: Visit 8 (4-weeks post-total knee arthroplasty (TKA))
measure: Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty
timeFrame: Visit 5 (1-week post-Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 7 (3-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 9 (2-months post-TKA), and Visit 10 (3-months post-TKA)
measure: Subject's Use of Device (Compliance)
timeFrame: Visit 4 (In-Hospital), Visit 6 (2-weeks post-Total Knee Arthroplasty (TKA)), and Visit 8 (4-weeks Post-TKA)
measure: Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay)
timeFrame: 1-week post-Total Knee Arthroplasty (TKA)
measure: Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay)
timeFrame: 1-week post-Total Knee Arthroplasty (TKA)
measure: Inpatient Pain Management Experience Survey (Discharge Facility)
timeFrame: 1-week post-Total Knee Arthroplasty (TKA)
measure: Inpatient Pain Management Experience Survey (Overall Rating of Hospital)
timeFrame: 1-week post-Total Knee Arthroplasty (TKA))
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Bellaire
country: United States
facility: HD Research
state: Texas
Study officials:
References: