Trial Outcomes & Findings for CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery (NCT NCT02257099)
NCT ID: NCT02257099
Last Updated: 2019-10-03
Results Overview
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
Cases
Case-only, patients with patellar instability and mal-alignment
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery
Baseline characteristics by cohort
| Measure |
Cases
n=20 Participants
Case-only study, patients with patellar instability or mal-alignment
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Conventional CT
n=20 Participants
conventional CT scan
|
CBCT
n=20 Participants
CBCT scan
|
|---|---|---|
|
Congruence Angle CBCT
|
26.7 degrees
Standard Deviation 18.1
|
3 degrees
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Conventional CT
n=20 Participants
conventional CT scan
|
CBCT
CBCT scan
|
|---|---|---|
|
Tilt Angle
|
18.2 degrees
Standard Deviation 11.6
|
—
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Conventional CT
n=20 Participants
conventional CT scan
|
CBCT
CBCT scan
|
|---|---|---|
|
Tibial Tuberosity Trochlear Groove
|
12.3 mm
Standard Deviation 6.3
|
—
|
Adverse Events
Cases
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