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OpenTrials
Completed

NCT Number: NCT04687306

Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts

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.

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Key information

Conditions

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68918, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries

Exclusion criteria

  • no history of spine/hip/pelvis issues
  • females who are trying to get pregnant

Treatment and study plan

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

Primary outcomes

  1. Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.

    Time frame: At study visit for up to 1 hour

    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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Inter-observer Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on Anteroposterior Pelvic Radiographs in Healthy Individuals.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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