Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
Conditions
Brief summary
25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.
Interventions
DEVICEZimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
DEVICEZimmer-Biomet Posterior Stabilizing total knee arthroplasty
Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Sponsors
Zimmer Biomet
The University of Tennessee, Knoxville
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will have a Zimmer Persona PCR or PS TKA. * Subjects must be at least six months post-operative. * Subjects will have KSS greater than 75. * Participants must be able to perform the required activities - stepping up and a deep knee bend. * Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study. * Bilateral subjects may be included in the subject population
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. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy. * Subjects without the required type of knee implant. * Subjects who are unable to perform stepping up and deep knee bend. * Subjects who are unwilling to sign Informed Consent/HIPAA documents. * Subjects who do not speak English and/or French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lateral Condyle Kinematic Translations - Step up | Baseline | Lateral Condyle Kinematics Translations during stepping up activity. 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 step 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. |
| Lateral Condyle Kinematics Translations - Deep Knee Bend | Baseline | Lateral Condyle Kinematics Translations during deep knee bend activity. 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 Condyle Kinematics Translations - Step Up | Baseline | Medial Condyle Kinematics Translations during stepping up activity. 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 step 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 Condyle Kinematics Translations - Deep Knee Bend | Baseline | Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. 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. |
Countries
France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Implanted With PCR TKA Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty | 25 |
| Subjects Implanted With PS TKA Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Zimmer-Biomet Posterior Stabilizing total knee arthroplasty: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Subjects Implanted With PCR TKA | Subjects Implanted With PS TKA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Lateral Condyle Kinematics Translations - Deep Knee Bend
Lateral Condyle Kinematics Translations during deep knee bend activity. 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 |
|---|---|---|---|
| Subjects Implanted With PCR TKA | Lateral Condyle Kinematics Translations - Deep Knee Bend | -1.52 mm | Standard Deviation 2.09 |
| Subjects Implanted With PS TKA | Lateral Condyle Kinematics Translations - Deep Knee Bend | -6.80 mm | Standard Deviation 3.47 |
Primary
Lateral Condyle Kinematic Translations - Step up
Lateral Condyle Kinematics Translations during stepping up activity. 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 step 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 |
|---|---|---|---|
| Subjects Implanted With PCR TKA | Lateral Condyle Kinematic Translations - Step up | 1.15 mm | Standard Deviation 3.03 |
| Subjects Implanted With PS TKA | Lateral Condyle Kinematic Translations - Step up | 2.28 mm | Standard Deviation 3.42 |
Primary
Medial Condyle Kinematics Translations - Deep Knee Bend
Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. 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 |
|---|---|---|---|
| Subjects Implanted With PCR TKA | Medial Condyle Kinematics Translations - Deep Knee Bend | 0.13 mm | Standard Deviation 2.09 |
| Subjects Implanted With PS TKA | Medial Condyle Kinematics Translations - Deep Knee Bend | -4.25 mm | Standard Deviation 3.32 |
Primary
Medial Condyle Kinematics Translations - Step Up
Medial Condyle Kinematics Translations during stepping up activity. 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 step 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 |
|---|---|---|---|
| Subjects Implanted With PCR TKA | Medial Condyle Kinematics Translations - Step Up | -0.36 mm | Standard Deviation 2.97 |
| Subjects Implanted With PS TKA | Medial Condyle Kinematics Translations - Step Up | 0.16 mm | Standard Deviation 3.91 |