Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
A Prospective Case Series Study of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement
1 other identifier
interventional
24
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2017
CompletedResults Posted
Study results publicly available
September 4, 2018
CompletedSeptember 4, 2018
August 1, 2018
1.7 years
April 22, 2015
July 17, 2018
August 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average Knee Pain While Walking
Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported.
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
Number of Participants That Experienced at Least One Study-Related Adverse Event
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Total of 21 months (from when the first subjects enrolled to when the last subject completed the study)
Secondary Outcomes (14)
Average Knee Pain Over the Last 24 Hours
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
Average Knee Pain at Rest
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
Amount of Analgesic Usage
Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))
Time to Achieve 90 Degrees Flexion in Affected Knee
Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)
- +9 more secondary outcomes
Study Arms (1)
Peripheral Nerve Stimulation
EXPERIMENTALAll study subjects will have up to 2 Smartpatch Leads placed in their leg that underwent total knee replacement, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
Interventions
The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. 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
You may qualify if:
- At least 21 years old
- Scheduled to undergo a primary unilateral total knee replacement procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California San Diego
La Jolla, California, 92037, United States
Duke University Medical Center
Durham, North Carolina, 22710, United States
Joint Implant Surgeons
New Albany, Ohio, 43054, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- SPR Therapeautics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
June 11, 2015
Study Start
October 22, 2015
Primary Completion
July 17, 2017
Study Completion
July 17, 2017
Last Updated
September 4, 2018
Results First Posted
September 4, 2018
Record last verified: 2018-08