Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
Completed · Not applicable
Conditions studied: Total Knee Replacement, Total Knee Arthroplasty, Pain, Postoperative Pain, Orthopedic Disorder
In brief
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.
Key facts
- Study ID
- NCT03286543
- Run by
- SPR Therapeutics, Inc.
- People needed
- 47
- Starts
- 2017-09-05
- Expected to finish
- 2020-04-15
- Last updated by the study team
- 2021-05-12
Who can join
Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California San Diego — La Jolla, California, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Joint Implant Surgeons — New Albany, Ohio, United States
- HD Research — Bellaire, Texas, United States
Full record on ClinicalTrials.gov
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