Trial Outcomes & Findings for Correlation of Spinopelvic Movement With Lateral Radiographs (NCT NCT05117229)

Results Overview

PT is a position dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and vertical axis. As recorded by theMetaWear sensor reported in degrees.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline

Results posted on

2023-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	MetaWear Sensor on Radiograph Subjects who had surgical orthopedic surgery had a MetaWear sensor added to their standard of care lateral sit to stand radiograph MetaWear Sensor: Sensor was placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs were taken.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MetaWear Sensor on Radiograph n=40 Participants Subjects who had surgical orthopedic surgery had a MetaWear sensor added to their standard of care lateral sit to stand radiograph MetaWear Sensor: Sensor was placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs were taken.
Age, Continuous	62.6 years STANDARD_DEVIATION 18.1 • n=40 Participants
Sex: Female, Male Female	26 Participants n=40 Participants
Sex: Female, Male Male	14 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants
Body Mass Index (BMI)	31.0 kg/m2 STANDARD_DEVIATION 6.3 • n=40 Participants

PRIMARY outcome

Timeframe: Baseline

PT is a position dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and vertical axis. As recorded by theMetaWear sensor reported in degrees.

Outcome measures

Outcome measures
Measure	MetaWear Sensor on Radiograph n=40 Participants Subjects who had surgical orthopedic surgery had a MetaWear sensor added to their standard of care lateral sit to stand radiograph MetaWear Sensor: Sensor was placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs were taken.
Pelvic Tilt (PT) Sitting	40.0 degrees Standard Deviation 11.9
Pelvic Tilt (PT) Standing	20.0 degrees Standard Deviation 10.5

PRIMARY outcome

Timeframe: Baseline

Sacral slope (SS) is a position-dependent parameter defined as the angle between a line parallel to the sacral end plate and a horizontal line. As recorded by theMetaWear sensor reported in degrees.

Outcome measures

Outcome measures
Measure	MetaWear Sensor on Radiograph n=40 Participants Subjects who had surgical orthopedic surgery had a MetaWear sensor added to their standard of care lateral sit to stand radiograph MetaWear Sensor: Sensor was placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs were taken.
Sacral Slope (SS) Standing	33.2 degrees Standard Deviation 11.34
Sacral Slope (SS) Sitting	16.2 degrees Standard Deviation 11.0

PRIMARY outcome

Timeframe: Baseline

PI is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting the same point to the center of the bicoxofemoral axis. As recorded by theMetaWear sensor reported in degrees.

Outcome measures

Outcome measures
Measure	MetaWear Sensor on Radiograph n=40 Participants Subjects who had surgical orthopedic surgery had a MetaWear sensor added to their standard of care lateral sit to stand radiograph MetaWear Sensor: Sensor was placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs were taken.
Pelvic Incidence (PI)	52.0 degrees Standard Deviation 12.6

Adverse Events

MetaWear Sensor on Radiograph

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

Rafael J. Sierra, M.D.

Mayo Clinic

Phone: 507-284-2226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place