In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Breg Osteoarthritis Brace gait fluoroscopy; Other: Gait fluoroscopy without brace; Diagnostic test: JointVue ultrasound; Diagnostic test: Computer Tomography

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital
    • Denver, Colorado, United States, 80210
      • Colorado Joint Replacement
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • University of Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medial Condylar Separation With Brace	Medial condylar separation during gait	One day
Medial Condylar Separation Without Brace	Medial condylar separation during gait	One day

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: BREG, Inc
• Investigators: Principal Investigator: Richard Komistek, PhD, University of Tennessee

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2019
• Primary Completion (ACTUAL): November 6, 2020
• Study Completion (ACTUAL): November 6, 2020

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: WIRB20191576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Drug and device information, study documents

• 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