In Vivo Three-Dimensional Determination of Osteoarthritis Brace Effectiveness
1 other identifier
interventional
23
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2019
CompletedFirst Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2020
CompletedResults Posted
Study results publicly available
October 12, 2021
CompletedOctober 12, 2021
October 1, 2021
1.3 years
September 23, 2019
May 10, 2021
October 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Medial Condylar Separation With Brace
Medial condylar separation during gait
One day
Medial Condylar Separation Without Brace
Medial condylar separation during gait
One day
Study Arms (1)
Subjects diagnosed with osteoarthritis of the knee
EXPERIMENTALSubjects must be diagnosed with marked unicompartimental degenerative joint space narrowing.
Interventions
Gait under fluoroscopy surveillance with brace
Gait under fluoroscopy surveillance without brace
JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones
Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Tennessee, Knoxvillelead
- BREG, Inccollaborator
Study Sites (3)
Colorado Joint Replacement
Denver, Colorado, 80210, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
University of Tennessee
Knoxville, Tennessee, 37996, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael LaCour
- Organization
- University of Tennessee
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Komistek, PhD
University of Tennessee
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 23, 2019
First Posted
October 1, 2019
Study Start
July 12, 2019
Primary Completion
November 6, 2020
Study Completion
November 6, 2020
Last Updated
October 12, 2021
Results First Posted
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
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.