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| ID | Type | Description | Link |
|---|---|---|---|
| R011373503 | Other Identifier | University of Tennessee |
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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there is no hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DePuy Attune PS FB TKA | Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Attune posterior stabilizing fixed bearing knee system | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend | Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity. | 3 months post-operative |
| Femoro-tibial Kinematics: Translation and Lift-off for Gait | Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity. | 3 months post-operative |
| Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down | Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity. | 3 months post-operative |
| Femoro-tibial Kinematics - Deep Knee Bend | Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity. | 3 months post-operative |
| Femoro-tibial Kinematics - Gait | Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity. | 3 months post-operative |
| Femoro-tibial Kinematics - Ramp Down | Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity. | 3 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Max Ground Reaction Force - Deep Knee Bend | Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force." |
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Inclusion Criteria:
Exclusion Criteria:
- Pregnant or potentially pregnant females will be excluded from the study
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Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas Fehring of OrthoCarolina, PA in Charlotte, NC.
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| Name | Affiliation | Role |
|---|---|---|
| Adrija Sharma, Ph. D. | University of Tennessee | Principal Investigator |
| William R Hamel, Ph. D. | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States | ||
| The University of Tennessee |
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| ID | Title | Description |
|---|---|---|
| FG000 | DePuy Attune PS FB TKA | Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 3 months post-operative |
| Max Ground Reaction Force - Gait | Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force." | 3 months post-operative |
| Max Ground Reaction Force - Ramp Down | Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force." | 3 months post-operative |
| Knoxville |
| Tennessee |
| 37996 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DePuy Attune PS FB TKA | Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend | Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity. | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics: Translation and Lift-off for Gait | Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity. | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down | Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity. | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
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| Secondary | Max Ground Reaction Force - Deep Knee Bend | Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force." | Posted | Mean | Standard Deviation | percentage of body weight | 3 months post-operative |
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| Secondary | Max Ground Reaction Force - Gait | Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force." | Posted | Mean | Standard Deviation | percentage of body weight | 3 months post-operative |
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| Secondary | Max Ground Reaction Force - Ramp Down | Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force." | Posted | Mean | Standard Deviation | percentage of body weight | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics - Deep Knee Bend | Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity. | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics - Gait | Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity. | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics - Ramp Down | Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity. | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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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 | DePuy Attune PS FB TKA | Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrija Sharma, Ph. D. | The University of Tennessee | 8659742093 | asharma1@utk.edu |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Lateral Anterior Posterior Gait |
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| Medial Anterior Posterior Gait |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Lateral Anterior Posterior Ramp Down |
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| Medial Anterior Posterior Ramp Down |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Axial Rotation Deep Knee Bend |
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| Max weight-bearing flexion Deep knee bend |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Axial Rotation Gait |
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| Max Weight-bearing flexion Gait |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Axial Rotation Ramp Down |
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| Max Weight-bearing flexion Ramp Down |
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