N/A N=23 Treatment

In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT04111276 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Medial Condylar Separation With Brace — 0.60 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Breg Osteoarthritis Brace gait fluoroscopy (Device); Gait fluoroscopy without brace (Other); JointVue ultrasound (Diagnostic_test); Computer Tomography (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Tennessee, Knoxville
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Medial Condylar Separation With Brace	0.60	—
PRIMARY Medial Condylar Separation Without Brace	-1.05	—

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.

Eligibility Criteria

Inclusion Criteria

Must be a patient of Colorado Joint Replacement.
Must be diagnosed with marked unicompartimental degenerative joint space narrowing.
Bilateral subjects may not be included in the subject population

Exclusion Criteria

Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
Subjects who are unable to perform normal walking.
Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
Does not speak English.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04111276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.