In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

Osteoarthritis, Knee Clinical Trial

Official title:

In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111276
• Other study ID #: WIRB20191576
• Status: Completed
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: November 6, 2020

Study information

• Verified date: October 2021
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	BREG, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medial Condylar Separation With Brace	Medial condylar separation during gait	One day
Primary	Medial Condylar Separation Without Brace	Medial condylar separation during gait	One day