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In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

NCT04111276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-10-12

Study results available
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Summary

In vivo knee kinematics will be assessed for 20 subjects that have been clinically diagnosed with substantial unicompartmental osteoarthritis (OA) by one of the surgeons of Colorado Joint Replacement; this is the location from which participants will be recruited. The objective of this study will be to analyze subjects with symptomatic unicompartmental osteoarthritis under in vivo dynamic, weight-bearing conditions using video fluoroscopy to determine if present-day OA knee braces provide separation of the femoral condyle from the tibial plateau, thus avoiding excessive loads on the degenerative compartment.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Breg Osteoarthritis Brace gait fluoroscopy

Gait under fluoroscopy surveillance with brace

OTHER

Gait fluoroscopy without brace

Gait under fluoroscopy surveillance without brace

DIAGNOSTIC_TEST

JointVue ultrasound

JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones

DIAGNOSTIC_TEST

Computer Tomography

Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur

Sponsors & Collaborators

  • BREG, Inc

    collaborator INDUSTRY

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

  • Richard Komistek, PhD · University of Tennessee

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Device
Yes

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 NCT04111276 on ClinicalTrials.gov