Trial Outcomes & Findings for Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts (NCT NCT04687306)
NCT ID: NCT04687306
Last Updated: 2026-05-26
Results Overview
Intraclass correlation coefficient (ICC) was used to assess \[inter-rater/intra-rater/test-retest\] reliability. ICC values range from 0 to 1, where values closer to 1 indicate stronger agreement and values closer to 0 indicate weaker agreement, will be used to evaluate the consistency of the 4 providers in measuring the sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions.
COMPLETED
33 participants
At study visit for up to 1 hour
2026-05-26
Participant Flow
Participant milestones
| Measure |
Females
15 females
X-rays- total of 4: X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
|
Males
15 Males
X-rays- total of 4: X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Females
n=15 Participants
15 females
X-rays- total of 4: X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
|
Males
n=15 Participants
15 Males
X-rays- total of 4: X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 6.5 • n=15 Participants
|
34.5 years
STANDARD_DEVIATION 7.1 • n=15 Participants
|
34.2 years
STANDARD_DEVIATION 6.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: At study visit for up to 1 hourIntraclass correlation coefficient (ICC) was used to assess \[inter-rater/intra-rater/test-retest\] reliability. ICC values range from 0 to 1, where values closer to 1 indicate stronger agreement and values closer to 0 indicate weaker agreement, will be used to evaluate the consistency of the 4 providers in measuring the sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions.
Outcome measures
| Measure |
Females
n=15 Participants
15 females
X-rays- total of 4: X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
|
Males
n=15 Participants
15 Males
X-rays- total of 4: X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
|
|---|---|---|
|
Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.
Standing
|
.956 Intraclass Correlation Coefficient
Interval 0.916 to 0.978
|
.956 Intraclass Correlation Coefficient
Interval 0.916 to 0.978
|
|
Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.
Sitting
|
.974 Intraclass Correlation Coefficient
Interval 0.944 to 0.988
|
.974 Intraclass Correlation Coefficient
Interval 0.944 to 0.988
|
Adverse Events
Females
Males
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