Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINTĀ® Peripheral Nerve Stimulation (PNS) System
Purpose
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 Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.
Conditions
- Postoperative Pain
- Total Knee Replacement
- Total Knee Arthroplasty
- Partial Knee Replacement
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Group 1 (Treatment) |
Participants in Group 1 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks. |
|
Sham Comparator Group 2 (Control) |
Participants in Group 2 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Participants will then have the option to crossover and receive stimulation therapy. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04341948
- Status
- Completed
- Sponsor
- SPR Therapeutics, Inc.