Trial Outcomes & Findings for In Vivo Determination of 3D Patellofemoral Mechanics (NCT NCT01290627)
NCT ID: NCT01290627
Last Updated: 2019-10-29
Results Overview
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
COMPLETED
30 participants
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
2019-10-29
Participant Flow
Patients were recruited from the Colorado Joint Replacement practice of Drs. Doug Dennis and Brian Haas in Denver, CO after the study was approved by respective IRBs beginning 5/27/11.
Participant milestones
| Measure |
Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
Subjects with normal knees
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In Vivo Determination of 3D Patellofemoral Mechanics
Baseline characteristics by cohort
| Measure |
Knee Prosthesis LCS PS RP TKA
n=10 Participants
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
n=10 Participants
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
n=10 Participants
Subjects with normal knees
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
64.3 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
34.2 years
STANDARD_DEVIATION 8.9 • n=27 Participants
|
53.67 years
STANDARD_DEVIATION 16.18 • n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
30 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.Population: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
Outcome measures
| Measure |
Knee Prosthesis LCS PS RP TKA
n=10 Implants/Knees
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
n=10 Implants/Knees
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
n=10 Implants/Knees
Subjects with normal knees
|
|---|---|---|---|
|
Patella Flexion With Respect to Femur
|
80.0 degrees
Standard Deviation 13.6
|
83.4 degrees
Standard Deviation 12.9
|
93.7 degrees
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.Population: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.
Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.
Outcome measures
| Measure |
Knee Prosthesis LCS PS RP TKA
n=10 Implants/Knees
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
n=10 Implants/Knees
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
n=10 Implants/Knees
Subjects with normal knees
|
|---|---|---|---|
|
Patella Rotation With Respect to Femur
|
.5 degrees
Standard Deviation 5.0
|
-.06 degrees
Standard Deviation 3.1
|
-1.6 degrees
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.Population: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.
full extension to maximum flexion for participants with and without implants.
Outcome measures
| Measure |
Knee Prosthesis LCS PS RP TKA
n=10 Implants/Knees
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
n=10 Implants/Knees
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
n=10 Participants
Subjects with normal knees
|
|---|---|---|---|
|
Patella Tilt With Respect to Femur
|
4.2 degrees
Standard Deviation 5.1
|
2.6 degrees
Standard Deviation 6.4
|
5.3 degrees
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.Population: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.
full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal
Outcome measures
| Measure |
Knee Prosthesis LCS PS RP TKA
n=10 Implants/Knees
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
n=10 Implants/Knees
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
n=10 Implants/Knees
Subjects with normal knees
|
|---|---|---|---|
|
Normalized Medial Patella Contact Point Translation
|
.34 ratio of patella height
Standard Deviation .18
|
.12 ratio of patella height
Standard Deviation .17
|
.40 ratio of patella height
Standard Deviation .41
|
PRIMARY outcome
Timeframe: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.Population: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.
full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."
Outcome measures
| Measure |
Knee Prosthesis LCS PS RP TKA
n=10 Implants/Knees
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Knee Prosthesis Sigma PS RP TKA
n=10 Implants/Knees
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
Control
n=10 Implants/Knees
Subjects with normal knees
|
|---|---|---|---|
|
Normalized Lateral Patella Contact Point Translation
|
0.09 ratio of patella height
Standard Deviation .22
|
.20 ratio of patella height
Standard Deviation .17
|
.45 ratio of patella height
Standard Deviation .52
|
Adverse Events
Knee Prosthesis LCS PS RP TKA
Knee Prosthesis Sigma PS RP TKA
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place