Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
NCT ID: NCT02468934
Last Updated: 2018-09-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2015-10-22
2017-07-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
NCT03286543
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
NCT01996254
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)
NCT01641471
Effects of TENS Therapy Following Arthroscopic Knee Surgery
NCT01528228
TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
NCT05470244
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Peripheral Nerve Stimulation
All 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.
SPRINT Peripheral Nerve Stimulation (PNS) System
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPRINT Peripheral Nerve Stimulation (PNS) System
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled to undergo a primary unilateral total knee replacement procedure
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SPR Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Diego
La Jolla, California, United States
Duke University Medical Center
Durham, North Carolina, United States
Joint Implant Surgeons
New Albany, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0141-CSP-000
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.