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Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.
The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.
This specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Females | 15 females |
| |
| Males | 15 Males |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-rays- total of 4 | Diagnostic Test | X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements. | 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. | At study visit for up to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy individuals, both male and females aged 25-50 without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries
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| Name | Affiliation | Role |
|---|---|---|
| Kevin L Garvin, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68918 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements. | 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. | Posted | Mean | 95% Confidence Interval | Intraclass Correlation Coefficient | At study visit for up to 1 hour |
|
A single visit, for up to 1 hour. Adverse events were monitored during the study visit.
No adverse events reported
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Garvin | University of Nebraska Medical Center | 402.559.4251 | kgarvin@unmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2023 | May 22, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2021 | May 22, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2025 | May 22, 2026 | ICF_002.pdf |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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