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| ID | Type | Description | Link |
|---|---|---|---|
| R011373372 | Other Grant/Funding Number | DePuy Orthopaedics |
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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints. These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Prosthesis LCS PS RP TKA | Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
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| Knee Prosthesis Sigma PS RP TKA | Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
| |
| Control | Subjects with normal knees |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subjects implanted with DePuy LCS PS RP TKA | Device | Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
| Measure | Description | Time Frame |
|---|---|---|
| Patella Flexion With Respect to Femur | Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants. | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. |
| Patella Rotation With Respect to Femur | Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards. | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. |
| Patella Tilt With Respect to Femur | full extension to maximum flexion for participants with and without implants. | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. |
| Normalized Medial Patella Contact Point Translation | full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.
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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 |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | 80210 | United States | ||
| Porter Adventist Hospital |
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Patients were recruited from the Colorado Joint Replacement practice of Drs. Doug Dennis and Brian Haas in Denver, CO after the study was approved by respective IRBs beginning 5/27/11.
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| ID | Title | Description |
|---|---|---|
| FG000 | Knee Prosthesis LCS PS RP TKA | Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
| FG001 | Knee Prosthesis Sigma PS RP TKA | Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
| FG002 | Control | Subjects with normal knees |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Knee Prosthesis LCS PS RP TKA | Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
| BG001 | Knee Prosthesis Sigma PS RP TKA |
| 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 | Patella Flexion With Respect to Femur | Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants. | Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants. | Posted | Mean | Standard Deviation | degrees | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. | Implants/Knees | Implants/Knees |
|
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There were no adverse effects or events encountered for any subjects in 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 | Knee Prosthesis LCS PS RP TKA | Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
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No adverse effects, events or unexpected risks occurred The sample size per group was small Age of the TKA groups were matched, the age of the normal subjects were not Cartilage thickness for normals had to be assumed as MRIs could not be obtained
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Komistek, Ph. D. | The University of Tennessee | 86598744159 | rkomiste@utk.edu |
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| Subjects implanted with DePuy Sigma PS RP TKA | Device | Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) |
|
| Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. |
| Normalized Lateral Patella Contact Point Translation | full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)." | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. |
| Denver |
| Colorado |
| 80210 |
| United States |
| Perkins Hall | Knoxville | Tennessee | 37996 | United States |
| Science and Engineering Research Facility | Knoxville | Tennessee | 37996 | United States |
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
| BG002 | Control | Subjects with normal knees |
| BG003 | Total | Total of all reporting groups |
| 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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Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
| OG002 | Control | Subjects with normal knees |
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| Primary | Patella Rotation With Respect to Femur | Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards. | Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants. | Posted | Mean | Standard Deviation | degrees | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. | Implants/Knees | Implants/Knees |
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| Primary | Patella Tilt With Respect to Femur | full extension to maximum flexion for participants with and without implants. | Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants. | Posted | Mean | Standard Deviation | degrees | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. | Implants/Knees | Implants/Knees |
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| Primary | Normalized Medial Patella Contact Point Translation | full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal | Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants. | Posted | Mean | Standard Deviation | ratio of patella height | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. | Implants/Knees | Implants/Knees |
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| Primary | Normalized Lateral Patella Contact Point Translation | full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)." | Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants. | Posted | Mean | Standard Deviation | ratio of patella height | Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months. | Implants/Knees | Implants/Knees |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Knee Prosthesis Sigma PS RP TKA | Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) | 0 | 10 | 0 | 10 |
| EG002 | Control | Subjects with normal knees | 0 | 10 | 0 | 10 |
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