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Brace

Subjects diagnosed with osteoarthritis of the knee for Osteoarthritis

N/A
Waitlist Available
Led By Richard Komistek, PhD
Research Sponsored by The University of Tennessee, Knoxville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Medial Condylar Separation With Brace
Medial Condylar Separation Without Brace
Secondary study objectives
Medial condylar separation with brace
Medial condylar separation without brace

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects diagnosed with osteoarthritis of the kneeExperimental Treatment4 Interventions
Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JointVue ultrasound
2019
N/A
~30
Breg Osteoarthritis Brace gait fluoroscopy
2019
N/A
~30
Computer Tomography
2019
N/A
~30

Find a Location

Who is running the clinical trial?

BREG, IncIndustry Sponsor
3 Previous Clinical Trials
347 Total Patients Enrolled
2 Trials studying Osteoarthritis
251 Patients Enrolled for Osteoarthritis
The University of Tennessee, KnoxvilleLead Sponsor
85 Previous Clinical Trials
18,719 Total Patients Enrolled
7 Trials studying Osteoarthritis
270 Patients Enrolled for Osteoarthritis
Richard Komistek, PhDPrincipal Investigator - University of Tennessee
The University of Tennessee, Knoxville
2 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Osteoarthritis
100 Patients Enrolled for Osteoarthritis
~4 spots leftby Oct 2025
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