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Efficacy Study of an Unloading Brace for Knee Osteoarthritis

NCT02150057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-10-22

Study results available
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Summary

Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Breg Fusion Unloading Brace

This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.

Sponsors & Collaborators

  • BREG, Inc

    collaborator INDUSTRY

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Roger Ostrander, MD · Andrews Institute for Orthopaedics & Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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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 NCT02150057 on ClinicalTrials.gov