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| Name | Class |
|---|---|
| BREG, Inc | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects diagnosed with osteoarthritis of the knee | Experimental | Subjects must be diagnosed with marked unicompartimental degenerative joint space narrowing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breg Osteoarthritis Brace gait fluoroscopy | Device | Gait under fluoroscopy surveillance with brace |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Komistek, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | 80210 | United States | ||
| Porter Adventist Hospital |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Diagnosed With Osteoarthritis of the Knee | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2019 | Oct 7, 2021 |
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| Gait fluoroscopy without brace | Other | Gait under fluoroscopy surveillance without brace |
|
| JointVue ultrasound | Diagnostic Test | JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones |
|
| Computer Tomography | Diagnostic Test | Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur |
|
| Denver |
| Colorado |
| 80210 |
| United States |
| University of Tennessee | Knoxville | Tennessee | 37996 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Diagnosed With Osteoarthritis of the Knee | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medial Condylar Separation With Brace | Medial condylar separation during gait | Posted | Mean | Standard Deviation | mm | One day |
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| Primary | Medial Condylar Separation Without Brace | Medial condylar separation during gait | Posted | Mean | Standard Deviation | mm | One day |
|
|
One day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Diagnosed With Osteoarthritis of the Knee | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael LaCour | University of Tennessee | 865-974-7684 | mlacour@utk.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2019 | Oct 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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