CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Breg Osteoarthritis Brace gait fluoroscopy +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04111276
NCT04111276N/ACompleted

In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

The University of Tennessee, Knoxville·interventional·Posted Oct 1, 2019·Updated Oct 12, 2021

In Brief

A clinical study evaluating Breg Osteoarthritis Brace gait fluoroscopy, Gait fluoroscopy without brace, and 2 other interventions for Osteoarthritis, Knee. Completed, enrolled 23 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBREG, Inc

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 1, 2019
Enrollment StartJul 12, 2019
Primary CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.8 years ago

Interventions

Breg Osteoarthritis Brace gait fluoroscopydevice

Gait under fluoroscopy surveillance with brace

Gait fluoroscopy without braceother

Gait under fluoroscopy surveillance without brace

JointVue ultrasoundother

JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones

Computer Tomographyother

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