In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

• Sponsor: The University of Tennessee, Knoxville (Other)
• Overall Status: Completed
• CT.gov ID: NCT04111276
• Collaborator: BREG, Inc (Industry)
• Enrollment: 23
• Locations: 3
• Arm: 1
• Actual Duration (Months): 15.9
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Device: Breg Osteoarthritis Brace gait fluoroscopy; Other: Gait fluoroscopy without brace; Diagnostic Test: JointVue ultrasound; Diagnostic Test: Computer Tomography	N/A

Detailed 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.

Enrollment will be increased to 24 subjects to account for any dropouts. Medial joint space narrowing will be clinically assessed in all patients on standing anteroposterior radiographs. 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.

Subjects will be asked to perform gait without the assistance of an offloading brace while under fluoroscopic evaluation. Then, each subject will be fitted with a Breg, off-the-shelf OA brace and will perform normal gait while under fluoroscopic surveillance. To ensure each brace was fitted properly, Breg will be asked to send either a sales representative or an engineer to the evaluation site. Therefore, the sales representative or engineer will be asked to fit their brace on each of the subjects.

Since the skeletal geometry is different for every person, computer aided design (CAD) models of the femur and tibia will be created for each specific subject. In order to create these CAD models, each subject will be asked to undergo a three-dimensional (3D) ultrasound using the JointVue proprietary software to reconstruct 3D femoral and tibial bones. A representative from JointVue will be present during data collection to conduct the ultrasound procedure in order to create the CAD models.

Participants will be asked to schedule a CT scan at Porter Adventist Hospital at their convenience to aid in the development of the bone models. To ensure subject safety, CT will be limited to the affected knee and the rest of patient's body will be protected from radiation with lead protection. The CT scan will be limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness
• Actual Study Start Date: Jul 12, 2019
• Actual Primary Completion Date: Nov 6, 2020
• Actual Study Completion Date: Nov 6, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Subjects diagnosed with osteoarthritis of the knee Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.

Device: Breg Osteoarthritis Brace gait fluoroscopy; Gait under fluoroscopy surveillance with brace; Other: Gait fluoroscopy without brace; Gait under fluoroscopy surveillance without brace; Diagnostic Test: JointVue ultrasound; JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones; Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

1. Medial Condylar Separation With Brace [One day]

   Medial condylar separation during gait

2. Medial Condylar Separation Without Brace [One day]

   Medial condylar separation during gait

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado Joint Replacement	Denver	Colorado	United States	80210
2	Porter Adventist Hospital	Denver	Colorado	United States	80210
3	University of Tennessee	Knoxville	Tennessee	United States	37996

Sponsors and Collaborators

• The University of Tennessee, Knoxville
• BREG, Inc

Investigators

• Principal Investigator: Richard Komistek, PhD, University of Tennessee

Study Documents (Full-Text)

• Study Protocol - Jul 11, 2019
• Statistical Analysis Plan - Jul 11, 2019

More Information

Publications

None provided.

• Responsible Party: Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville
• ClinicalTrials.gov Identifier: NCT04111276
• Other Study ID Numbers: WIRB20191576
• First Posted: Oct 1, 2019
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Subjects Diagnosed With Osteoarthritis of the Knee
Arm/Group Description	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
Period Title: Overall Study
STARTED	23
COMPLETED	20
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Subjects Diagnosed With Osteoarthritis of the Knee
Arm/Group Description	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 Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.3 (7.36)
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Medial Condylar Separation With Brace
Description	Medial condylar separation during gait
Time Frame	One day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Diagnosed With Osteoarthritis of the Knee
Arm/Group Description	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
Measure Participants	20
Mean (Standard Deviation) [mm]	0.60 (1.14)

2. Primary Outcome

Title	Medial Condylar Separation Without Brace
Description	Medial condylar separation during gait
Time Frame	One day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Diagnosed With Osteoarthritis of the Knee
Arm/Group Description	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
Measure Participants	20
Mean (Standard Deviation) [mm]	-1.05 (1.00)

Adverse Events

Time Frame	One day
Arm/Group Title	Subjects Diagnosed With Osteoarthritis of the Knee
Arm/Group Description	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
All Cause Mortality
	Subjects Diagnosed With Osteoarthritis of the Knee
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Subjects Diagnosed With Osteoarthritis of the Knee
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Subjects Diagnosed With Osteoarthritis of the Knee
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.