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In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness

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ClinicalTrials.gov Identifier: NCT04111276
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
BREG, Inc
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

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
Osteoarthritis, Knee 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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Comparative analysis during stance phase of gait without brace [ Time Frame: One day ]
    Analysis of images during stance phase of gait

  2. Comparative analysis during stance phase of gait with brace [ Time Frame: One day ]
    Analysis of images during stance phase of gait


Secondary Outcome Measures :
  1. Medial condylar separation with brace [ Time Frame: One day ]
    Medial condylar separation during gait

  2. Medial condylar separation without brace [ Time Frame: One day ]
    Medial condylar separation during gait



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Colorado Joint Replacement that have been clinically diagnosed with substantial unicompartmental osteoarthritis (OA)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111276


Contacts
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Contact: Richard Komistek, PhD 865-974-4159 rkomiste@utk.edu
Contact: Michael LaCour, PhD 865-974-7684 mlacour@utk.edu

Locations
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United States, Colorado
Colorado Joint Replacement Recruiting
Denver, Colorado, United States, 80210
Contact: Douglas Dennis, MD    720-524-1367    DouglasDennis@Centura.Org   
Contact: Roseann Johnson    720-524-1367    RoseannJohnson@Centura.org   
Principal Investigator: Douglas Dennis, MD         
Sub-Investigator: Lindsay Kleeman-Forsthuber, MD         
Sub-Investigator: Jason Jennings, MD         
Sub-Investigator: Jacob Elkins, MD         
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Roseann Johnson    303-778-1955    RoseannJohnson@Centura.org   
Principal Investigator: Douglas Dennis, MD         
United States, Tennessee
University of Tennessee Active, not recruiting
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
The University of Tennessee, Knoxville
BREG, Inc
Investigators
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Principal Investigator: Richard Komistek, PhD University of Tennessee
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Responsible Party: Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT04111276    
Other Study ID Numbers: WIRB20191576
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases