Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
Conditions
Keywords
total knee arthroplasty
Brief summary
The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith & Nephew BCS TKA and compared these kinematics data to those of normal knees.
Detailed description
The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Journey II PCR or BCR TKA and compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith & Nephew Journey II BCS TKA.
Interventions
DEVICEJourney II posterior cruciate retaining total knee arthroplasty
DEVICEJourney II posterior bi-cruciate retaining total knee arthroplasty
Sponsors
The University of Tennessee, Knoxville
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Must have must either a Smith & Nephew Journey II PCR or BCR TKA * Must be at least three months post-operative * Must have a Knee Society score of \>90 with no ligamentous laxity or pain * Weigh 250 pounds or less * Should have good-to-excellent post-operative flexion * Must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend * Must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities * Must have body mass index (BMI) of less than 38 * Must be between 40-85 years of age * Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms to participate in the study
Exclusion criteria
* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study * Subjects without the required types of knee implants * Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain * Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lateral Kinematics Translations While Ascending Ramp | Baseline | Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Medial Kinematics Translations While Ascending Ramp | Baseline | Anterior Posterior (AP) translations of medial femoral condyles during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Axial Rotation While Ascending Ramp | Baseline | Femorotibial axial rotation during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Lateral Kinematics Translations While Descending Ramp | Baseline | Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Medial Kinematics Translations While Descending Ramp | Baseline | Anterior Posterior (AP) translations of medial femoral condyles during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Axial Rotation While Descending Ramp | Baseline | Femorotibial axial rotation during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Lateral Kinematics Translations During Deep Knee Bend | Baseline | Anterior Posterior (AP) translations of lateral femoral condyles during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Medial Kinematics Translations During Deep Knee Bend | Baseline | Anterior Posterior (AP) translations of medial femoral condyles during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Axial Rotation During Deep Knee Bend | Baseline | Femorotibial axial rotation during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
| Maximum Flexion During Deep Knee Bend | Baseline | Maximum weight-bearing femorotibial flexion during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial range of motion) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive values are the only possible values in this case, representing the magnitude of weight-bearing flexion. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Smith & Nephew Journey II PCR TKA Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty
Journey II posterior cruciate retaining total knee arthroplasty | 40 |
| Smith & Nephew Journey II BCR TKA Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty
Journey II posterior bi-cruciate retaining total knee arthroplasty | 10 |
| Total | 50 |
Baseline characteristics
| Characteristic | Smith & Nephew Journey II PCR TKA | Smith & Nephew Journey II BCR TKA | Total |
|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 7.55 | 62.3 years STANDARD_DEVIATION 4.32 | 66.3 years STANDARD_DEVIATION 7.26 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 5 Participants | 32 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 10 |
| other Total, other adverse events | 0 / 40 | 0 / 10 |
| serious Total, serious adverse events | 0 / 40 | 0 / 10 |
Outcome results
Primary
Axial Rotation During Deep Knee Bend
Femorotibial axial rotation during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Axial Rotation During Deep Knee Bend | 5.9 degrees | Standard Deviation 5.7 |
| Smith & Nephew Journey II BCR TKA | Axial Rotation During Deep Knee Bend | 6.0 degrees | Standard Deviation 7 |
Primary
Axial Rotation While Ascending Ramp
Femorotibial axial rotation during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Axial Rotation While Ascending Ramp | -2.6 degrees | Standard Deviation 6.3 |
| Smith & Nephew Journey II BCR TKA | Axial Rotation While Ascending Ramp | -2.0 degrees | Standard Deviation 4 |
Primary
Axial Rotation While Descending Ramp
Femorotibial axial rotation during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Axial Rotation While Descending Ramp | -1.2 degrees | Standard Deviation 6.2 |
| Smith & Nephew Journey II BCR TKA | Axial Rotation While Descending Ramp | 3.7 degrees | Standard Deviation 7.1 |
Primary
Lateral Kinematics Translations During Deep Knee Bend
Anterior Posterior (AP) translations of lateral femoral condyles during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Lateral Kinematics Translations During Deep Knee Bend | -3.7 mm | Standard Deviation 5.8 |
| Smith & Nephew Journey II BCR TKA | Lateral Kinematics Translations During Deep Knee Bend | -9.4 mm | Standard Deviation 6.1 |
Primary
Lateral Kinematics Translations While Ascending Ramp
Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Lateral Kinematics Translations While Ascending Ramp | 0.1 mm | Standard Deviation 5.9 |
| Smith & Nephew Journey II BCR TKA | Lateral Kinematics Translations While Ascending Ramp | -0.4 mm | Standard Deviation 3.1 |
Primary
Lateral Kinematics Translations While Descending Ramp
Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Lateral Kinematics Translations While Descending Ramp | 0.1 mm | Standard Deviation 6.4 |
| Smith & Nephew Journey II BCR TKA | Lateral Kinematics Translations While Descending Ramp | -6.3 mm | Standard Deviation 7.5 |
Primary
Maximum Flexion During Deep Knee Bend
Maximum weight-bearing femorotibial flexion during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial range of motion) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive values are the only possible values in this case, representing the magnitude of weight-bearing flexion. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Maximum Flexion During Deep Knee Bend | 112.3 degrees | Standard Deviation 14 |
| Smith & Nephew Journey II BCR TKA | Maximum Flexion During Deep Knee Bend | 105.4 degrees | Standard Deviation 12.8 |
Primary
Medial Kinematics Translations During Deep Knee Bend
Anterior Posterior (AP) translations of medial femoral condyles during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Medial Kinematics Translations During Deep Knee Bend | 1.0 mm | Standard Deviation 4.2 |
| Smith & Nephew Journey II BCR TKA | Medial Kinematics Translations During Deep Knee Bend | -4.4 mm | Standard Deviation 3.8 |
Primary
Medial Kinematics Translations While Ascending Ramp
Anterior Posterior (AP) translations of medial femoral condyles during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Medial Kinematics Translations While Ascending Ramp | -1.8 mm | Standard Deviation 3.9 |
| Smith & Nephew Journey II BCR TKA | Medial Kinematics Translations While Ascending Ramp | -2.0 mm | Standard Deviation 1.3 |
Primary
Medial Kinematics Translations While Descending Ramp
Anterior Posterior (AP) translations of medial femoral condyles during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smith & Nephew Journey II PCR TKA | Medial Kinematics Translations While Descending Ramp | -1.0 mm | Standard Deviation 3.4 |
| Smith & Nephew Journey II BCR TKA | Medial Kinematics Translations While Descending Ramp | -3.2 mm | Standard Deviation 3.6 |