Osteoarthritis, Knee
Conditions
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.
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.
Interventions
DEVICEBreg Osteoarthritis Brace gait fluoroscopy
Gait under fluoroscopy surveillance with brace
OTHERGait fluoroscopy without brace
Gait under fluoroscopy surveillance without brace
DIAGNOSTIC_TESTJointVue ultrasound
JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones
DIAGNOSTIC_TESTComputer 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
Sponsors
BREG, Inc
The University of Tennessee, Knoxville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medial Condylar Separation With Brace | One day | Medial condylar separation during gait |
| Medial Condylar Separation Without Brace | One day | Medial condylar separation during gait |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Subjects Diagnosed With Osteoarthritis of the Knee | — |
|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 7.36 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Medial Condylar Separation With Brace
Medial condylar separation during gait
Time frame: One day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Diagnosed With Osteoarthritis of the Knee | Medial Condylar Separation With Brace | 0.60 mm | Standard Deviation 1.14 |
Primary
Medial Condylar Separation Without Brace
Medial condylar separation during gait
Time frame: One day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Diagnosed With Osteoarthritis of the Knee | Medial Condylar Separation Without Brace | -1.05 mm | Standard Deviation 1 |