Trial Outcomes & Findings for Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis (NCT NCT01290640)
NCT ID: NCT01290640
Last Updated: 2019-10-21
Results Overview
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.
COMPLETED
22 participants
March 2013
2019-10-21
Participant Flow
09/2011-12/2012, hospital
Participant milestones
| Measure |
Subjects Implanted With a DePuy Fixed-bearing Total Condylar I
Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
|
Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
Baseline characteristics by cohort
| Measure |
PFC RP TC3 TKA
n=10 Participants
|
Subjects Implanted With a DePuy Fixed-bearing Total Condylar I
n=12 Participants
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
74.06 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
72.5 years
STANDARD_DEVIATION 10.10 • n=206 Participants
|
PRIMARY outcome
Timeframe: March 2013Population: Per protocol.
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.
Outcome measures
| Measure |
Subjects With DePuy PFC Rotating Platform TC3 TKA
n=10 Implants
|
Subjects With DePuy PFC Fixed Bearing TC3 TKA
n=12 Implants
|
|---|---|---|
|
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
|
-2.52 mm
Standard Deviation 1.92
|
|
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
|
-1.40 mm
Standard Deviation 1.43
|
|
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
|
2.89 mm
Standard Deviation 3.64
|
|
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
|
1.02 mm
Standard Deviation 2.95
|
|
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
|
-1.3 mm
Standard Deviation 1.8
|
|
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
|
-1.2 mm
Standard Deviation 1.5
|
|
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
|
-1.92 mm
Standard Deviation 2.46
|
|
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
|
-1.71 mm
Standard Deviation 1.80
|
PRIMARY outcome
Timeframe: March 2013Angular 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.
Outcome measures
| Measure |
Subjects With DePuy PFC Rotating Platform TC3 TKA
n=10 Implants
|
Subjects With DePuy PFC Fixed Bearing TC3 TKA
n=12 Implants
|
|---|---|---|
|
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
|
1.99 degrees
Standard Deviation 4.00
|
|
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
|
-2.42 degrees
Standard Deviation 5.03
|
|
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
|
.13 degrees
Standard Deviation 2.18
|
|
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
|
.24 degrees
Standard Deviation 4.17
|
Adverse Events
Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA
Subjects Implanted With a DePuy Fixed-bearing Total Condylar I
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Richard Komistek, Professor
The University of Tennessee
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place