Clinical Trials Directory

Trials / Completed

CompletedNCT03286543

Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System

A Prospective, Comparative Effectiveness Randomized Controlled Trial of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
SPR Therapeutics, Inc. · Industry
Sex
All
Age
21 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard of care, alone. This study involves a device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta 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 Beta Stimulator). About half the subjects in this study will receive the SPRINT Beta system (treatment group) and half will not (control group). Both groups will receive the standard of care.

Conditions

Interventions

TypeNameDescription
DEVICESPRINT Beta SystemThe SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT Beta 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 Beta Stimulator).

Timeline

Start date
2017-09-05
Primary completion
2020-04-15
Completion
2020-04-15
First posted
2017-09-18
Last updated
2021-05-12
Results posted
2021-05-12

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03286543. Inclusion in this directory is not an endorsement.