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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects implanted with PCR TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty |
| |
| Subjects implanted with PS TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty | Device | Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lateral Condyle Kinematic Translations - Step up | Lateral Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Baseline |
| Lateral Condyle Kinematics Translations - Deep Knee Bend | Lateral Condyle Kinematics Translations during deep knee bend activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Baseline |
| Medial Condyle Kinematics Translations - Step Up | Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Baseline |
| Medial Condyle Kinematics Translations - Deep Knee Bend |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with a Zimmer-Biomet posterior cruciate retaining (PCR) or Zimmer-Biomet posterior stabilizing total knee arthroplasty (TKA)
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| Name | Affiliation | Role |
|---|---|---|
| Richard Komistek, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Institute | Bryn Mawr | Pennsylvania | 19010 | United States | ||
| University of Tennessee |
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 Implanted With PCR TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty |
| FG001 | Subjects Implanted With PS TKA |
| 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 | Jan 3, 2019 | Nov 6, 2020 |
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| Zimmer-Biomet Posterior Stabilizing total knee arthroplasty | Device | Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
|
Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
| Baseline |
| Knoxville |
| Tennessee |
| 37996 |
| United States |
| The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite | Marseille | 13009 | France |
Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Implanted With PCR TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty |
| BG001 | Subjects Implanted With PS TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 | Lateral Condyle Kinematic Translations - Step up | Lateral Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Posted | Mean | Standard Deviation | mm | Baseline |
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| Primary | Lateral Condyle Kinematics Translations - Deep Knee Bend | Lateral Condyle Kinematics Translations during deep knee bend activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Posted | Mean | Standard Deviation | mm | Baseline |
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| Primary | Medial Condyle Kinematics Translations - Step Up | Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Posted | Mean | Standard Deviation | mm | Baseline |
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| Primary | Medial Condyle Kinematics Translations - Deep Knee Bend | Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. | Posted | Mean | Standard Deviation | mm | Baseline |
|
Baseline. Data is collected only on a single day, and no participant follow-up was collected. Thus, this section describes whether or not there were any adverse events on the single day of data collection
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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 PCR TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Subjects Implanted With PS TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael LaCour | University of Tennessee | 8659742093 | mlacour@utk.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 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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| Between 18 and 65 years |
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| >=65 years |
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