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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty was analyzed by the Center for Musculoskeletal Research in a past research study, and it was determined that subjects experienced more normal-like kinematic patterns. They also achieved excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the revised design to determine if subjects experience normal-like kinematic patterns and if greater weight-bearing knee flexion is achieved. The objective for this study is to analyze the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and compare those patterns to subjects having a normal knee and those having the 1st generation Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smith & Nephew Journey II BCS TKA | Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates |
| |
| Normal knee | Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey II BCS TKA | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kinematics Translations During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB | 3 months post-operative |
| Kinematics During Deep Knee Bend (DKB) Activity | Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB | 3 months post-operative |
| Kinematics Translations During Squat to Stand (S2S) Activity | Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S | 3 months post-operative |
| Kinematics During Squat to Stand (S2S) Activity | Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S | 3 months post-operative |
| Kinematics Translations During Ramp up Activity | AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity | 3 months post-operative |
| Kinematics During Ramp up Activity | AR of the femur during Ramp Up activity | 3 months post-operative |
| Kinematics Translations During Ramp Down Activity | AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity |
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Inclusion Criteria for implanted subjects:
Exclusion Criteria for implanted subjects:
Inclusion Criteria for non-implanted subjects:
Exclusion Criteria for non-implanted subjects:
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Patients implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) implanted by Dr. Harold E. Cates or subjects with a healthy knee
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Komistek, Ph D | Employee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Orthopaedic Clinic | Knoxville | Tennessee | 37923 | United States | ||
| Tennessee Orthopaedic Foundation for Education and Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Smith & Nephew Journey II BCS TKA | Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates Journey II BCS TKA |
| FG001 | Normal Knee | Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Smith & Nephew Journey II BCS TKA | Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates Journey II BCS TKA |
| BG001 | Normal Knee |
| 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 Translations During Deep Knee Bend (DKB) Activity | Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB | 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 | Smith & Nephew Journey II BCS TKA | Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates Journey II BCS TKA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard D. Komistek, Ph. D. | University of Tennessee | 8659742093 | rkomiste@utk.edu |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 3 months post-operative |
| Kinematics During Ramp Down Activity | AR of the femur during ramp down activity | 3 months post-operative |
| Knoxville |
| Tennessee |
| 37923 |
| United States |
| The University of Tennessee | Knoxville | Tennessee | 37996 | United States |
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Kinematics During Deep Knee Bend (DKB) Activity | Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
|
|
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| Primary | Kinematics Translations During Squat to Stand (S2S) Activity | Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
|
|
|
| Primary | Kinematics During Squat to Stand (S2S) Activity | Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
|
|
|
| Primary | Kinematics Translations During Ramp up Activity | AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
|
|
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| Primary | Kinematics During Ramp up Activity | AR of the femur during Ramp Up activity | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
|
|
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| Primary | Kinematics Translations During Ramp Down Activity | AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity | Posted | Mean | Standard Deviation | mm | 3 months post-operative |
|
|
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| Primary | Kinematics During Ramp Down Activity | AR of the femur during ramp down activity | Posted | Mean | Standard Deviation | degrees | 3 months post-operative |
|
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| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Normal Knee | Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies | 0 | 10 | 0 | 10 |
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| Medial Anterior Posterior Translation 66% to 100% |
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| Lateral Anterior Posterior Translation 0-33% |
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| Lateral Anterior Posterior Translation 33%-66% |
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| Lateral Anterior Posterior Translation 66%-100% |
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| AR 66% to 100% |
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| Medial Anterior Posterior Translation 66% to 100% |
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| Lateral Anterior Posterior Translation 0-33% |
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| Lateral Anterior Posterior Translation 33%-66% |
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| Lateral Anterior Posterior Translation 66%-100% |
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| AR 66% to 100% |
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