N/A
Completed N=56
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
Postoperative Pain · Total Knee Replacement · Total Knee Arthroplasty · Partial Knee Replacement
Source: ClinicalTrials.gov NCT04341948 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity — 12; 5 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity |
7; 3 | — |
| PRIMARY Study-Related Adverse Device Effects |
9; 14; 5 | — |
| SECONDARY Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity |
7; 3 | — |
| SECONDARY Long-term Durability of Average Pain Relief: Number of Participants With ≥ 50% Reduction in Average Pain Intensity |
10.00; 5.00; 9.96; 9.02; 10.36 | — |
| SECONDARY Mean Pain Relief |
7.26; 7.21; 4.37; 5.65; 3.32; 5.34 | — |
| SECONDARY Pain Medication Usage |
8; 9; 11; 10; 8; 8 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
24.30; 27.14; 12.53; 16.47; 9.30; 14.75 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
1.42; 1.05; 1.80; 1.15; 1.75; 0.75 | — |
| SECONDARY Pain Interference: Number of Participants With ≥ 50% Reduction in Pain Interference |
13.00; 11.00; 11.00; 6.00; 11.20; 11.16 | — |
| SECONDARY Function (i.e., Physical Recovery) |
16.00; 11.00; 13.00; 9.00; 11.42; 12.22 | — |
| SECONDARY Six Minute Walk Test (6MWT) |
267.29; 291.94; 354.29; 253.36; 318.11; 269.77 | — |
Eligibility Criteria
Key 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
Key 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
Data sourced from ClinicalTrials.gov (NCT04341948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.