Status:
COMPLETED
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
Lead Sponsor:
SPR Therapeutics, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Postoperative Pain
Total Knee Replacement
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral...
Eligibility Criteria
Inclusion
- Key
- At least 21 years old
- Underwent a 1. primary total knee replacement (TKR), 2. secondary/revision TKR or 3. Partial/unicompartmental knee replacement (PKR)
- Knee pain directly resulting from Knee Replacement surgery in affected knee
- Key
Exclusion
- Current high opioid use
- Body Mass Index (BMI) \> 40 kg/m2
- Conditions with increased risk of infection
- Implanted electronic device
- History of bleeding or clotting disorder.
- Uncontrolled Diabetes Mellitus Types I or II
- Pregnancy
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04341948
Start Date
August 6 2020
End Date
June 27 2024
Last Update
August 27 2025
Active Locations (10)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of California San Diego
San Diego, California, United States, 92103
3
The Orthopaedic Institute
Gainesville, Florida, United States, 32607
4
Better Health Clinical Research, Inc
Newnan, Georgia, United States, 30265