Trial Outcomes & Findings for In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness (NCT NCT04111276)

Results Overview

Medial condylar separation during gait

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

One day

Results posted on

2021-10-12

Participant milestones
Measure	Subjects Diagnosed With Osteoarthritis of the Knee Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing. Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones 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
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Subjects Diagnosed With Osteoarthritis of the Knee n=20 Participants Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing. Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones 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
Age, Continuous	67.3 years STANDARD_DEVIATION 7.36 • n=20 Participants
Sex: Female, Male Female	8 Participants n=20 Participants
Sex: Female, Male Male	12 Participants n=20 Participants

Timeframe: One day

Medial condylar separation during gait

Outcome measures
Measure	Subjects Diagnosed With Osteoarthritis of the Knee n=20 Participants Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing. Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones 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
Medial Condylar Separation With Brace	0.60 mm Standard Deviation 1.14

Timeframe: One day

Medial condylar separation during gait

Outcome measures
Measure	Subjects Diagnosed With Osteoarthritis of the Knee n=20 Participants Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing. Breg Osteoarthritis Brace gait fluoroscopy: Gait under fluoroscopy surveillance with brace Gait fluoroscopy without brace: Gait under fluoroscopy surveillance without brace JointVue ultrasound: JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones 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
Medial Condylar Separation Without Brace	-1.05 mm Standard Deviation 1.00

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Tennessee

Phone: 865-974-7684