Clinical trial NCT02468934: Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
Official title: A Prospective Case Series Study 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 Disorders
Keywords: electrical stimulation
neurostimulation
neuromodulation
TKA pain
pain following total knee replacement
total knee arthroplasty
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT 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 Stimulator).


Eligibility criteria: Key Inclusion Criteria:

* At least 21 years old
* Scheduled to undergo a primary unilateral total knee replacement procedure

Key Exclusion Criteria:

* Body Mass Index (BMI) \> 40 kg/m2
* Compromised immune system based on medical history
* History of valvular heart disease
* Implanted electronic device
* Joint or overlying skin infection of the affected limb
* History of recurrent skin infections
* 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 Participants That Experienced at Least One Study-Related Adverse Event
timeFrame: Total of 21 months (from when the first subjects enrolled to when the last 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: Amount of Analgesic Usage
timeFrame: Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))
measure: Number of Participants That Experienced at Least One Opioid-Related Side Effect
timeFrame: Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))
measure: Time to Achieve 90 Degrees Flexion in Affected Knee
timeFrame: Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)
measure: Timed Up and Go (TUG) Test
timeFrame: Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)
measure: 6 Minute Walk Test (6MWT)
timeFrame: Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)
measure: Fixed Distance Walk Test
timeFrame: Visit 1 (Baseline) and Visit 5 (In-Hospital)
measure: Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)
measure: Knee Pain Interference With Daily Activities
timeFrame: Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))
measure: Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
timeFrame: Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA))
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Visit 1 (Baseline), Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)), Visit 13 (3-months post-TKA)
measure: Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
timeFrame: From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came first
measure: Subject Satisfaction Survey
timeFrame: Visit 11 (6-weeks 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: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
Study officials:
References: