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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MetaWear Sensor on radiograph | Experimental | subjects being considered for surgical orthopedic surgery will have a MetaWear sensor added to their standard of care lateral sit to stand radiograph |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetaWear Sensor | Device | Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.
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| Name | Affiliation | Role |
|---|---|---|
| Rafael J Sierra, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | degrees | Baseline |
|
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Adverse events were collected from baseline to end of study, approximately one day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rafael J. Sierra, M.D. | Mayo Clinic | 507-284-2226 | Sierra.Rafael@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2021 | Oct 30, 2023 | Prot_000.pdf |
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All participants will have the MetaWear Sensors used on them
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Participants |
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| 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. | Posted | Mean | Standard Deviation | degrees | Baseline |
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| 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. | Posted | Mean | Standard Deviation | degrees | Baseline |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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