Status:
COMPLETED
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
Lead Sponsor:
SPR Therapeutics, Inc.
Conditions:
Total Knee Replacement
Total Knee Arthroplasty
Eligibility:
All Genders
21-90 years
Phase:
NA
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 replac...
Eligibility Criteria
Inclusion
- Key
- Scheduled to undergo a primary unilateral total knee replacement procedure
- Key
Exclusion
- 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
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03286543
Start Date
September 5 2017
End Date
April 15 2020
Last Update
May 12 2021
Active Locations (5)
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1
University of California San Diego
La Jolla, California, United States, 92037
2
Duke University Medical Center
Durham, North Carolina, United States, 22710
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Joint Implant Surgeons
New Albany, Ohio, United States, 43054