Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
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
1 other identifier
interventional
47
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2020
CompletedResults Posted
Study results publicly available
May 12, 2021
CompletedMay 12, 2021
May 1, 2021
2.6 years
August 31, 2017
April 13, 2021
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average Knee Pain While Walking
All subjects were asked to complete daily diaries to record their average pain intensity while walking during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for each diary period was calculated and a mean of all four diary periods was calculated (weeks 1-4). The mean group scores for weeks 1-4 are reported.
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)
Number of Subjects That Experienced at Least One Study-Related Adverse Event
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of Treatment Group subjects that experienced at least one study-related adverse event is reported here.
30 months (from when the first Treatment Group subject enrolled to when the last Treatment Group subject completed the study)
Secondary Outcomes (18)
Average Knee Pain Over the Last 24 Hours
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
Average Knee Pain at Rest
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
Pain Right Now as Measured by the Brief Pain Inventory
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)
Amount of Analgesic Usage
Visits 5-8 (weeks 1-4 post-Total Knee Arthroplasty (TKA))
Number of Subjects That Experienced at Least One Opioid-Related Side Effect
Baseline (Visit 2a/2b), Visits 4-11 (in-hospital days through 12-months post-Total Knee Arthroplasty (TKA))
- +13 more secondary outcomes
Study Arms (2)
Treatment Group (SPRINT Beta System)
EXPERIMENTALSubjects 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.
Control Group
NO INTERVENTIONSubjects in the control group will receive the standard of care.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Scheduled to undergo a primary unilateral total knee replacement procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of California San Diego
La Jolla, California, 92037, United States
Duke University Medical Center
Durham, North Carolina, 22710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Joint Implant Surgeons
New Albany, Ohio, 43054, United States
HD Research
Bellaire, Texas, 77401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- SPR Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 18, 2017
Study Start
September 5, 2017
Primary Completion
April 15, 2020
Study Completion
April 15, 2020
Last Updated
May 12, 2021
Results First Posted
May 12, 2021
Record last verified: 2021-05