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| ID | Type | Description | Link |
|---|---|---|---|
| IIS-13002 | Other Grant/Funding Number | DePuy Synthes |
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| Name | Class |
|---|---|
| DePuy Synthes | 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 continuation of the study will analyze 30 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DePuy Attune PS FB knee system | Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Attune posterior stabilizing fixed bearing knee system | Device | Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative. |
| Measure | Description | Time Frame |
|---|---|---|
| Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion | Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down | 3 months post-operative |
| Femoro-tibial Kinematics - Medial Anterior/Posterior Motion | Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down | 3 months post-operative |
| Femoro-tibial Kinematics - Axial Rotation | Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia. | 3 months post-operative |
| Femoro-tibial Kinematics - Weight-bearing Flexion | Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude. | 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 activity was normalized with respect to participant's body weight and has been termed "maximum reaction force." | 3 months post-operative |
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Inclusion Criteria:
At least three (3) months post-operative with no other surgical procedures conducted within the past six months
Exclusion Criteria:
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Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
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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 | ||
| Abercrombie Radiology |
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 | DePuy Attune PS FB Knee System | Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 |
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| 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 activity. was normalized with respect to participant's body weight 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 activity. was normalized with respect to participant's body weight and has been termed "maximum reaction force." | 3 months post-operative |
| Knoxville |
| Tennessee |
| 37909 |
| United States |
| Dougherty Engineering Building, Room M007 | Knoxville | Tennessee | 37996 | United States |
| Perkins Hall, The University of Tennessee | Knoxville | Tennessee | 37996 | United States |
| Science and Engineering Research Facility, The University of Tennessee | Knoxville | Tennessee | 37996 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DePuy Attune PS FB Knee System | Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative. |
| 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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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | 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 | Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion | Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics - Medial Anterior/Posterior Motion | Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down | 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 activity was normalized with respect to participant's body weight and has been termed "maximum reaction force." | Posted | Mean | Standard Deviation | proportion 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 activity. was normalized with respect to participant's body weight and has been termed "maximum reaction force." | Posted | Mean | Standard Deviation | proportion 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 activity. was normalized with respect to participant's body weight and has been termed "maximum reaction force." | Posted | Mean | Standard Deviation | proportion of body weight | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics - Axial Rotation | Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia. | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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| Primary | Femoro-tibial Kinematics - Weight-bearing Flexion | Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude. | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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3 years, one month
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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 Knee System | Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrija Sharma, Principal Investigator | University of Tennessee | 8659747684 | adrija.sharma@utk.edu |
| Feb 20, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| >=65 years |
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