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| ID | Type | Description | Link |
|---|---|---|---|
| R011373454 | Other Grant/Funding Number | Stryker Orthopaedic |
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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.
A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a Stryker Triathlon CR TKA | Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty. |
| |
| Patients with a Zimmer PCR TKA | Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA) | Device | The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematics - Deep Knee Bend Activity | Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity | 3 months post-operative |
| Kinematics - Ramp up Activity | Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity | 3 months post-operative |
| Kinematics - Ramp Down Activity | Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity | 3 months post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA
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| Name | Affiliation | Role |
|---|---|---|
| Adrija Sharma, Ph D | The University of Tennessee | Principal Investigator |
| Richard D Komistek, Ph D | The University of Tennessee | Principal Investigator |
| William R Hamel, Ph D | The University of Tennessee | Principal Investigator |
| Harold E Cates, MD | Tennessee Orthopaedic Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research | Knoxville | Tennessee | 37923 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With a Stryker Triathlon CR TKA | Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA |
| FG001 | Patients With a Zimmer PCR TKA | Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With a Stryker Triathlon CR TKA | Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA |
| BG001 | Patients With a Zimmer PCR TKA |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Kinematics - Deep Knee Bend Activity | Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
|
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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 | Patients With a Stryker Triathlon CR TKA | Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrija Sharma, Ph. D. | University of Tennessee | 8659742093 | asharma1@utk.edu |
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| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D019643 | Arthroplasty, Replacement |
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| Zimmer PCR TKA | Device | The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional. |
|
|
| 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 | Knoxville | Tennessee | 37996 | United States |
Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Kinematics - Ramp up Activity | Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
|
|
|
| Primary | Kinematics - Ramp Down Activity | Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Patients With a Zimmer PCR TKA | Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA | 0 | 25 | 0 | 25 |
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| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| Lateral Anterior Posterior Translation 66% to 100% |
|
| Medial Anterior Posterior Translation 0% to 33% |
|
| Medial Anterior Posterior Translation 33% to 66% |
|
| Medial Anterior Posterior Translation 66% to 100% |
|
| Axial Rotation 0% to 33% |
|
| Axial Rotation 33% to 66% |
|
| Axial Rotation 66% to 100% |
|
| Lateral Anterior Posterior Translation 66% to 100% |
|
| Medial Anterior Posterior Translation 0% to 33% |
|
| Medial Anterior Posterior Translation 33% to 66% |
|
| Medial Anterior Posterior Translation 66% to 100% |
|
| Axial Rotation 0% to 33% |
|
| Axial Rotation 33% to 66% |
|
| Axial Rotation 66% to 100% |
|