Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods

Completed

• Conditions: Healthy Volunteer
• Interventions: Other: Goniometric measure of pelvic extension reserve.; Other: Photographic measure of pelvic extension reserve.; Other: EOS measure of pelvic extension reserve.

• Registration Number: NCT01909258
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to describe for the first time the expansion reserve of the pelvic area (measurements using the EOS system) for each of the four morphotypes (Roussouly classification) commonly found in a population of healthy volunteers.

Detailed Description

Secondary objectives:

A. The intra-judge reproducibility and the interrater reliability for the different tools used to measure hip extension will be evaluated. Intra-judge reproducibility (photography) and interrater reliability (goniometry and photography) for the different tools used for measuring hip extension will be evaluated.

B. The concordance between EOS measurements and measurements acquired via goniometry and photography will be evaluated.

C. Describe certain radiographic measurements via the EOS system for the four morphotypes

Study Timeline

• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Study Start: 2015-01
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• The healthy volunteer must have given his/her informed and signed consent
• The healthy volunteer must be insured or beneficiary of a health insurance plan

Exclusion Criteria

• The healthy volunteer is participating in another study
• The healthy volunteer is in an exclusion period determined by a previous study
• The healthy volunteer is under judicial protection, under tutorship or curatorship
• The healthy volunteer refuses to sign the consent
• It is impossible to correctly inform the healthy volunteer
• The healthy volunteer is pregnant, parturient, or breastfeeding
• The healthy volunteers had a history of chronic pain or surgery at the hip, the thoracolumbar spine or the sacroiliac area
• The healthy volunteer has a hip, knee or ankle abnormality

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population.	Photographic measure of pelvic extension reserve.	Healthy volunteers 20 to 40 years of age. Intervention: Goniometric measure of pelvic extension reserve. Intervention: Photographic measure of pelvic extension reserve. Intervention: EOS measure of pelvic extension reserve.
The study population.	Goniometric measure of pelvic extension reserve.	Healthy volunteers 20 to 40 years of age. Intervention: Goniometric measure of pelvic extension reserve. Intervention: Photographic measure of pelvic extension reserve. Intervention: EOS measure of pelvic extension reserve.
The study population.	EOS measure of pelvic extension reserve.	Healthy volunteers 20 to 40 years of age. Intervention: Goniometric measure of pelvic extension reserve. Intervention: Photographic measure of pelvic extension reserve. Intervention: EOS measure of pelvic extension reserve.

Primary Outcome Measures

Name	Time	Method
EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)	baseline (day 0)	= RIEeos
EOS measurement of extrinsic extension reserve	Baseline (day 0)	= REEeos = angular variation of a specific angle (line joining the center of the sacral plate and the midpoint of the segment involving the center of the femoral head and the line joining this point to the top of the intercondylar knee notch) (left and right sides)
EOS measurement of global extension reserve	Baseline (day 0)	= RIEeos + REEeos (left and right sides)

Secondary Outcome Measures

Name	Time	Method
Goniometric measurement of global extension reserve	baseline (day 0)	(left and right sides)
Photographic measurement of global extension reserve	baseline (day 0)	(left and right sides)
Roussouly classification: 1, 2, 3 or 4	baseline (day 0)
Pelvic incidence (°)	Baseline (day 0)	Pelvic Incidence is defined as the angle between two lines: the line perpendicular to the sacral endplate at the middle of the sacral endplate to the line between the middle of the sacral endplate to the middle of the femoral heads.
Standing sacral slope at rest	Baseline (day 0)
Standing sacral slope in extension	Baseline (day 0)
Standing pelvic tilt at rest	Baseline (day 0)
Standing pelvic tilt in extension	Baseline (day 0)
Standing anterior pelvic plane	Baseline (day 0)
The front acetabular inclination while standing	Baseline (day 0)
The sagittal acetabular inclination while standing	Baseline (day 0)

Trial Locations

Locations (2)

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France