Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's
Conditions
Brief summary
The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.
Interventions
DEVICEMetaWear Sensor
Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
All participants will have the MetaWear Sensors used on them
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ability to provide informed consent. * Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures.
Exclusion criteria
\- Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Tilt (PT) | 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. |
| Sacral Slope (SS) | 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. |
| Pelvic Incidence (PI) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | MetaWear Sensor on Radiograph | — |
|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 18.1 | — |
| Body Mass Index (BMI) | 31.0 kg/m2 STANDARD_DEVIATION 6.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Pelvic Incidence (PI)
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MetaWear Sensor on Radiograph | Pelvic Incidence (PI) | 52.0 degrees | Standard Deviation 12.6 |
Primary
Pelvic Tilt (PT)
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MetaWear Sensor on Radiograph | Pelvic Tilt (PT) | Sitting | 40.0 degrees | Standard Deviation 11.9 |
| MetaWear Sensor on Radiograph | Pelvic Tilt (PT) | Standing | 20.0 degrees | Standard Deviation 10.5 |
Primary
Sacral Slope (SS)
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MetaWear Sensor on Radiograph | Sacral Slope (SS) | Sitting | 16.2 degrees | Standard Deviation 11 |
| MetaWear Sensor on Radiograph | Sacral Slope (SS) | Standing | 33.2 degrees | Standard Deviation 11.34 |