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Funding withdrawn, no participants recruited
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| Name | Class |
|---|---|
| MicroPort Orthopedics Inc. | INDUSTRY |
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In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic & Spine Center [this is the location from which participants will be recruited].
There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroPort Medial Pivot | Subjects will have been implanted with the MicroPort Medial Pivot TKA |
| |
| DePuy Attune | Subjects will have been implanted with the DePuy Attune PCR TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroPort Medial Pivot TKA | Device | Subjects will have been implanted with the MicroPort Medial Pivot TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kinematics Translations during Deep Knee Bend Activity | Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend | at least 6 months post-operative |
| Kinematics during Deep Knee Bend Activity | Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB | at least 6 months post-operative |
| Kinematics Translations during step up activity | Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity | at least 6 months post-operative |
| Kinematics during step up activity | Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity | at least 6 months post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion
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| Name | Affiliation | Role |
|---|---|---|
| Richard Komistek, Ph.D. | The University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevada Orthopedic & Spine Center | Las Vegas | Nevada | 89128 | United States | ||
| Platinum Training/MERIN |
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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| DePuy Attune PCR TKA | Device | Subjects will have been implanted with the DePuy Attune PCR TKA |
|
| Las Vegas |
| Nevada |
| 89130 |
| United States |
| The University of Tennessee | Knoxville | Tennessee | 37934 | United States |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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