Trial Outcomes & Findings for Stereo Radiography of TKA Patella Mechanics (NCT NCT02532933)
NCT ID: NCT02532933
Last Updated: 2019-11-27
Results Overview
Difference between dome and anatomic patellofemoral flexion, which is measured as the relative angle between the femoral and patellar components of the implant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
One day
Results posted on
2019-11-27
Participant Flow
Participant milestones
| Measure |
Medialized Dome Patella
Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry
DePuy Synthes Attune PS RP
|
Anatomic Patella
Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry
DePuy Synthes Attune PS RP
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Medialized Dome Patella
n=16 Participants
Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry
DePuy Synthes Attune PS RP
|
Anatomic Patella
n=16 Participants
Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry
DePuy Synthes Attune PS RP
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 5.3 • n=16 Participants
|
65.2 years
STANDARD_DEVIATION 6.8 • n=16 Participants
|
63.9 years
STANDARD_DEVIATION 6.1 • n=32 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=16 Participants
|
11 Participants
n=16 Participants
|
22 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=16 Participants
|
5 Participants
n=16 Participants
|
10 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: One dayDifference between dome and anatomic patellofemoral flexion, which is measured as the relative angle between the femoral and patellar components of the implant.
Outcome measures
| Measure |
Medialized Dome Patella
n=16 Participants
Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry
DePuy Synthes Attune PS RP
|
Anatomic Patella
n=16 Participants
Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry
DePuy Synthes Attune PS RP
|
|---|---|---|
|
Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant.
|
29.6 degrees
Standard Deviation 8.1
|
21.0 degrees
Standard Deviation 6.7
|
Adverse Events
Medialized Dome Patella
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anatomic Patella
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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