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NCT04111276

In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

Completed NA Results posted Last updated 12 October 2021
What this trial tests

NA trial testing Breg Osteoarthritis Brace gait fluoroscopy in Osteoarthritis, Knee in 23 participants. Completed in 6 November 2020.

Timeline
12 July 2019
Primary endpoint
6 November 2020
6 November 2020

Quick facts

Lead sponsorThe University of Tennessee, Knoxville
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment23
Start date12 July 2019
Primary completion6 November 2020
Estimated completion6 November 2020
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Tennessee, Knoxville

Who can join

18 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medial Condylar Separation With Brace Primary · One day

Medial condylar separation during gait

GroupValue95% CI
Subjects Diagnosed With Osteoarthritis of the Knee0.60± 1.14
Medial Condylar Separation Without Brace Primary · One day

Medial condylar separation during gait

GroupValue95% CI
Subjects Diagnosed With Osteoarthritis of the Knee-1.05± 1.00

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Osteoarthritis, Knee

Currently open trials in the same condition.

Other The University of Tennessee, Knoxville trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04111276.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing