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| ID | Type | Description | Link |
|---|---|---|---|
| R011373360 | Other Identifier | UT Grant |
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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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The objectives of this study are four-fold:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TC3 TKA | Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA |
| |
| PFC RP TC3 TKA | Subjects implanted with a DePuy PFC Rotating Platform TC3 TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy fixed-bearing Total Condylar III (TC3) TKA | Device |
| ||
| DePuy PFC Rotating Platform TC3 TKA |
| Measure | Description | Time Frame |
|---|---|---|
| In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative. | March 2013 |
| In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative. | March 2013 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects requiring total knee arthroplasty
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| Name | Affiliation | Role |
|---|---|---|
| Richard D. Komistek, Ph D | The University of Tennessee | Principal Investigator |
| Douglas Dennis, MD | Colorado Joint Replacement, Porter Adventist Hosp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States | ||
| Perkins Hall |
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09/2011-12/2012, hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Implanted With a DePuy Fixed-bearing Total Condylar I | Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA |
| FG001 | Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
|
| Knoxville |
| Tennessee |
| 37996 |
| United States |
| Science and Engineering Research Facility | Knoxville | Tennessee | 37996 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PFC RP TC3 TKA | |
| BG001 | Subjects Implanted With a DePuy Fixed-bearing Total Condylar I | |
| BG002 | Total | Total of all reporting groups |
| 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 | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative. | Per protocol. | Posted | Mean | Standard Deviation | mm | March 2013 | Implants | Implants |
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| Primary | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative. | Posted | Mean | Standard Deviation | degrees | March 2013 | Implants | Implants |
|
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There were no adverse events encountered for any subjects in either group.
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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 Implanted With a DePuy PFC Rotating Platform TC3 TKA | 0 | 10 | 0 | 10 | |||
| EG001 | Subjects Implanted With a DePuy Fixed-bearing Total Condylar I | 0 | 12 | 0 | 12 |
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No limitations were encountered.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Komistek, Professor | The University of Tennessee | 865-974-4159 | rkomiste@utk.edu |
| >=65 years |
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| Male |
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| Lateral Anterior Posterior Chair Rise |
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| Medial Anterior Posterior Chair Rise |
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| Lateral Anterior Posterior Gait |
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| Medial Anterior Posterior Gait |
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| Lateral Anterior Posterior Stair Descent |
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| Medial Anterior Posterior Stair Descent |
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| Implants |
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