Knee Arthroplasty, Knee Prosthesis
Conditions
Brief summary
The objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient. 2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise). 3. To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types. 4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.
Interventions
DEVICEDePuy fixed-bearing Total Condylar III (TC3) TKA
DEVICEDePuy PFC Rotating Platform TC3 TKA
Sponsors
DePuy Orthopaedics
The University of Tennessee, Knoxville
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be at least three months post-operative. 2. Potential subjects will have a body weight of less than 250 lbs. 3. Candidates must have had a HSS score \>90 post-operatively. 4. Patients must have passive flexion of at least 100. 5. All potential subjects will have a Press Fit Condylar (PFC) Rotating Platform Total Condylar III Prosthesis (Depuy Orthopaedics, Warsaw, IN) or fixed-bearing Total Condylar III Prosthesis. 6. Must be willing to sign both Informed Consent and HIPAA forms.
Exclusion criteria
1. Pregnant females. 2. Patients that do not meet study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | March 2013 | The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative. |
| In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | March 2013 | Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative. |
Countries
United States
Participant flow
Recruitment details
09/2011-12/2012, hospital
Participants by arm
| Arm | Count |
|---|---|
| PFC RP TC3 TKA | 10 |
| Subjects Implanted With a DePuy Fixed-bearing Total Condylar I | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | Total | PFC RP TC3 TKA | Subjects Implanted With a DePuy Fixed-bearing Total Condylar I |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 10 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72.5 years STANDARD_DEVIATION 10.1 | 70.7 years STANDARD_DEVIATION 9.8 | 74.06 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 22 participants | 10 participants | 12 participants |
| Sex: Female, Male Female | 13 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
Primary
In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative.
Time frame: March 2013
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Deep Knee Bend | 8.35 degrees | Standard Deviation 8.94 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Gait | 6.66 degrees | Standard Deviation 6.37 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Stair Descent | 8.16 degrees | Standard Deviation 5.56 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Chair Rise | 12.22 degrees | Standard Deviation 8.29 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Stair Descent | .24 degrees | Standard Deviation 4.17 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Deep Knee Bend | 1.99 degrees | Standard Deviation 4 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Chair Rise | -2.42 degrees | Standard Deviation 5.03 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Axial Rotation Gait | .13 degrees | Standard Deviation 2.18 |
Primary
In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.
The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.
Time frame: March 2013
Population: Per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Deep Knee Bend | -3.51 mm | Standard Deviation 4.73 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Deep Knee Bend | -1.68 mm | Standard Deviation 2.15 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Chair Rise | -10.31 mm | Standard Deviation 3.23 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Chair Rise | -0.76 mm | Standard Deviation 3.95 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Gait | -0.88 mm | Standard Deviation 2.02 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Gait | .70 mm | Standard Deviation 2.51 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Stair Descent | -8.18 mm | Standard Deviation 2.08 |
| Subjects With DePuy PFC Rotating Platform TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Stair Descent | -1.96 mm | Standard Deviation 3.22 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Stair Descent | -1.71 mm | Standard Deviation 1.8 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Deep Knee Bend | -2.52 mm | Standard Deviation 1.92 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Gait | -1.3 mm | Standard Deviation 1.8 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Deep Knee Bend | -1.40 mm | Standard Deviation 1.43 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Stair Descent | -1.92 mm | Standard Deviation 2.46 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Lateral Anterior Posterior Chair Rise | 2.89 mm | Standard Deviation 3.64 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Gait | -1.2 mm | Standard Deviation 1.5 |
| Subjects With DePuy PFC Fixed Bearing TC3 TKA | In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities. | Medial Anterior Posterior Chair Rise | 1.02 mm | Standard Deviation 2.95 |