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Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty

NCT03840096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-09

No results posted yet for this study

Summary

Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.

Conditions

Interventions

DEVICE

Breg Flex

All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery.

Sponsors & Collaborators

  • BREG, Inc

    collaborator INDUSTRY

  • The Hawkins Foundation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-06-15
Completion
2021-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03840096 on ClinicalTrials.gov