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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith & Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.
The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith & Nephew PCR, BCR, and BCS TKA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stryker Triathlon PCR TKA | Subjects implanted with a Stryker Triathlon PCR TKA |
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| Stryker Triathlon PS TKA | Subjects implanted with a Stryker Triathlon PS TKA |
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| Zimmer Persona PCR TKA | Subjects implanted with a Zimmer Persona PCR TKA |
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| Zimmer Persona PS TKA | Subjects implanted with a Zimmer Persona PS TKA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon PCR TKA | Device | Total Knee Arthroplasty System |
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| Measure | Description | Time Frame |
|---|---|---|
| Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle. | 3 months post-operative |
| Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle. | 3 months post-operative |
| Maximum Flexion, in Degrees, During Deep Knee Bend Activity | Maximum weight-bearing flexion, in degrees, during deep knee bend activity | 3 months post-operative |
| Axial Rotation, in Degrees, During Deep Knee Bend Activity | Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation. | 3 months post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with a Stryker Triathlon PCR, Stryker Triathlon PS, Zimmer Persona PCR, or Zimmer Persona PS total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Komistek, PhD | The University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Orthopaedic Clinic | Knoxville | Tennessee | 37923 | United States | ||
| The University of Tennessee |
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 | Stryker Triathlon PCR TKA | Subjects implanted with a Stryker Triathlon PCR TKA Triathlon PCR TKA: Total Knee Arthroplasty System |
| FG001 | Stryker Triathlon PS TKA | Subjects implanted with a Stryker Triathlon PS TKA Triathlon PS TKA: Total Knee Arthroplasty System |
| 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 | May 16, 2022 |
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| Triathlon PS TKA |
| Device |
Total Knee Arthroplasty System |
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| Persona PCR TKA | Device | Total Knee Arthroplasty System |
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| Persona PS TKA | Device | Total Knee Arthroplasty System |
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| Knoxville |
| Tennessee |
| 37996 |
| United States |
| FG002 | Zimmer Persona PCR TKA | Subjects implanted with a Zimmer Persona PCR TKA Persona PCR TKA: Total Knee Arthroplasty System |
| FG003 | Zimmer Persona PS TKA | Subjects implanted with a Zimmer Persona PS TKA Persona PS TKA: Total Knee Arthroplasty System |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stryker Triathlon PCR TKA | Subjects implanted with a Stryker Triathlon PCR TKA Triathlon PCR TKA: Total Knee Arthroplasty System |
| BG001 | Stryker Triathlon PS TKA | Subjects implanted with a Stryker Triathlon PS TKA Triathlon PS TKA: Total Knee Arthroplasty System |
| BG002 | Zimmer Persona PCR TKA | Subjects implanted with a Zimmer Persona PCR TKA Persona PCR TKA: Total Knee Arthroplasty System |
| BG003 | Zimmer Persona PS TKA | Subjects implanted with a Zimmer Persona PS TKA Persona PS TKA: Total Knee Arthroplasty System |
| BG004 | Total | Total of all reporting groups |
| 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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| 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 | Number | 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 | Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle. | Posted | Mean | Standard Deviation | millimeters | 3 months post-operative |
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| Primary | Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle. | Posted | Mean | Standard Deviation | millimeters | 3 months post-operative |
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| Primary | Maximum Flexion, in Degrees, During Deep Knee Bend Activity | Maximum weight-bearing flexion, in degrees, during deep knee bend activity | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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| Primary | Axial Rotation, in Degrees, During Deep Knee Bend Activity | Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation. | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
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Adverse events would occur and therefore are collected only during the single day of data collection. Thus, we would know right away, and therefore the specific time period is 1 day. There is no participant follow up after data collection, and participants were not monitored after data collection.
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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 | Stryker Triathlon PCR TKA | Subjects implanted with a Stryker Triathlon PCR TKA Triathlon PCR TKA: Total Knee Arthroplasty System | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | Stryker Triathlon PS TKA | Subjects implanted with a Stryker Triathlon PS TKA Triathlon PS TKA: Total Knee Arthroplasty System | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Zimmer Persona PCR TKA | Subjects implanted with a Zimmer Persona PCR TKA Persona PCR TKA: Total Knee Arthroplasty System | 0 | 29 | 0 | 29 | 0 | 29 |
| EG003 | Zimmer Persona PS TKA | Subjects implanted with a Zimmer Persona PS TKA Persona PS TKA: Total Knee Arthroplasty System | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael LaCour | University of Tennessee | 865-974-9376 | mlacour@utk.edu |
| May 16, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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