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

NCT04687306 | Completed Results

• 1 other identifier: 0719-20-FB
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Females

15 females

Diagnostic Test: X-rays- total of 4

Males

15 Males

Diagnostic Test: X-rays- total of 4

Interventions

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

Females; Males

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy individuals, both male and females aged 25-50 without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68918, United States

Location

Results Point of Contact

• Title: Dr. Kevin Garvin
• Organization: University of Nebraska Medical Center

kgarvin@unmc.edu

402.559.4251

Study Officials

• Kevin L Garvin, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 29, 2020
• Study Start: January 15, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)