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

Healthy Volunteer Clinical Trial

— CRESPEOS  

Official title:

Comparison and Reproducibility of Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods: Clinical Observation Versus Photography Versus the EOS Imaging System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909258
• Other study ID #: AOI/2012/PK
• Secondary ID: 2013-A00232-43
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: May 19, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Other:
• Goniometric measure of pelvic extension reserve.
The pelvic extension reserve (°) is measured via goniometry. The goniometric measurements will be taken once by an investigator on all subjects and once by a different investigator on half of the subjects (with balanced distribution of morphotypes).
• Photographic measure of pelvic extension reserve.
The pelvic extension reserve (°) is measured using photography. Photographic measurements will be performed twice one investigator and 1 time by a different investigator (total of three measurements).
• EOS measure of pelvic extension reserve.
The pelvic extension reserve (°) is measured using the imaging system EOS. Five X-rays will be made for each volunteer on the EOS system. The first is a frontal shot in a bipedal position, reference snapshot for verifying the absence of spinal deformity or hip pathology. The second and third are profile shots, one on the left and one on the right, whole body, bipedal position; serving as a reference picture. The fourth is profile shot, whole body, with the left hip in hyperextension. For maximum left hip hyperextension, the right leg rests on a step of varying height, and the hip is maximally flexed. The fifth is a profile shot, full body, with the right hip in hyperextension. For a maximum right hip hyperextension, the left leg rests on a step of varying height, and the hip is maximally flexed.

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)	= RIEeos	baseline (day 0)	No
Primary	EOS measurement of extrinsic extension reserve	= 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)	Baseline (day 0)	No
Primary	EOS measurement of global extension reserve	= RIEeos + REEeos (left and right sides)	Baseline (day 0)	No
Secondary	Goniometric measurement of global extension reserve	(left and right sides)	baseline (day 0)	No
Secondary	Photographic measurement of global extension reserve	(left and right sides)	baseline (day 0)	No
Secondary	Roussouly classification: 1, 2, 3 or 4		baseline (day 0)	No
Secondary	Pelvic incidence (°)	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.	Baseline (day 0)	No
Secondary	Standing sacral slope at rest		Baseline (day 0)	No
Secondary	Standing sacral slope in extension		Baseline (day 0)	No
Secondary	Standing pelvic tilt at rest		Baseline (day 0)	No
Secondary	Standing pelvic tilt in extension		Baseline (day 0)	No
Secondary	Standing anterior pelvic plane		Baseline (day 0)	No
Secondary	The front acetabular inclination while standing		Baseline (day 0)	No
Secondary	The sagittal acetabular inclination while standing		Baseline (day 0)	No