N/A
N=27
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
Total Knee Replacement · Total Knee Arthroplasty · Pain · Postoperative Pain · Orthopedic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02468934 ↗Enrolled (actual)
27
Serious AEs
4.2%
Results posted
Sep 2018
Primary outcome: Primary: Average Knee Pain While Walking — 3.8 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPRINT Peripheral Nerve Stimulation (PNS) System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- SPR Therapeutics, Inc.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Knee Pain While Walking |
3.8 | — |
| PRIMARY Number of Participants That Experienced at Least One Study-Related Adverse Event |
15 | — |
| SECONDARY Average Knee Pain Over the Last 24 Hours |
3.5 | — |
| SECONDARY Average Knee Pain at Rest |
2.9 | — |
| SECONDARY Amount of Analgesic Usage |
15.9 | — |
| SECONDARY Number of Participants That Experienced at Least One Opioid-Related Side Effect |
7; 1; 13; 17; 11; 11 | — |
| SECONDARY Time to Achieve 90 Degrees Flexion in Affected Knee |
40.0; 16.0; 36.5; 16.0 | — |
| SECONDARY Timed Up and Go (TUG) Test |
12.3; 39.0; 13.9; 10.5; 8.7 | — |
| SECONDARY 6 Minute Walk Test (6MWT) |
363.0; 289.0; 365.8; 410.3 | — |
| SECONDARY Fixed Distance Walk Test |
18.1; 48.5 | — |
| SECONDARY Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC) |
-2.3; 39.0; 64.5; 88.5 | — |
| SECONDARY Knee Pain Interference With Daily Activities |
4.2; 4.4; 3.6; 3.1; 3.1; 2.4 | — |
| SECONDARY Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey |
3; 8; 7; 6; 11; 3 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
5.5; 2.0; 0.0 | — |
| SECONDARY Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA) |
1.0; 1.0; 19.5; 1.0; 7.0; 1.0 | — |
| SECONDARY Subject Satisfaction Survey |
17; 10; 8; 12; 14; 1 | — |
Summary
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT 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 Stimulator).
Eligibility Criteria
Key Inclusion Criteria
- At least 21 years old
- Scheduled to undergo a primary unilateral total knee replacement procedure
Key Exclusion Criteria
- Body Mass Index (BMI) > 40 kg/m2
- Compromised immune system based on medical history
- History of valvular heart disease
- Implanted electronic device
- Joint or overlying skin infection of the affected limb
- History of recurrent skin infections
- Bleeding disorder
- Allergy to skin surface electrodes and/or medical-grade adhesive tapes
- Pregnant
Data sourced from ClinicalTrials.gov (NCT02468934). 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.