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| ID | Type | Description | Link |
|---|---|---|---|
| R01 1373 424 | Other Identifier | The University of Tennessee |
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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.
Additional hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly | subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly | Device | Sigma PS RP TKA including a polyethylene insert with 4 beads |
|
| Measure | Description | Time Frame |
|---|---|---|
| In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity | The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, 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. | 10 yrs post-operative |
| Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity | 10 yrs post-operative | |
| Range of Motion During Flexion of Deep Knee Bend Activity | 10 yrs post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity | The intended unit of measure is "times Body Weight" (or xBW), relating to a ratio. | 10 yrs post-operative |
| Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are eight mobile bearing subjects that were implanted over 10 years ago with a custom polyethylene insert that has four beads rigidly inserted into the polyethylene component.
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Komistek, Ph. D. | The University of Tennessee | Principal Investigator |
| Dennis A Douglas, MD | Colorado Joint Replacement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Porter Adventist Hospital, Colorado Joint Replacement | Denver | Colorado | 80210 | United States | ||
| Perkins Hall, The University of Tennessee |
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hospital, medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly | subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly | subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation. |
| 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 |
| 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 Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity | The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, 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. | Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation. | Posted | Mean | Standard Deviation | mm | 10 yrs post-operative | Implants | Implants |
|
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There were no adverse effects or events encountered for any subjects for this study.
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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 | Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly | subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation. |
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Small study population; only one specific type of mobile bearing implant was analyzed; no definitive way to quantitatively measure level of wear on various implants to determine if there was any influence on the kinematic performance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Komistek, Ph. D. | The University of Tennessee | 8659744159 | rkomiste@utk.edu |
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| 10 yrs post-operative |
| Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity | 10 yrs post-operative |
| Knoxville |
| Tennessee |
| 37996 |
| United States |
| Science and Engineering Research Facility, The University of Tennessee | Knoxville | Tennessee | 37996 | United States |
| 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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| Secondary | In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity | The intended unit of measure is "times Body Weight" (or xBW), relating to a ratio. | Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation | Posted | Mean | Standard Deviation | times body weight | 10 yrs post-operative | Implants | Implants |
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| Primary | Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity | Posted | Mean | Standard Deviation | degrees | 10 yrs post-operative | Implants | Implants |
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| Primary | Range of Motion During Flexion of Deep Knee Bend Activity | Posted | Mean | Standard Deviation | degrees | 10 yrs post-operative | Implants | Implants |
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| Secondary | Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity | Posted | Mean | Standard Deviation | mm^2 | 10 yrs post-operative | Implants | Implants |
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| Secondary | Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity | Posted | Mean | Standard Deviation | MPa | 10 yrs post-operative | Implants | Implants |
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| 0 |
| 8 |
| 0 |
| 8 |
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