Clinical trial NCT01909258: Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers 20 to 30 years of age.

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

Eligibility criteria: 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

Primary outcomes:
measure: EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)
timeFrame: baseline (day 0)
measure: EOS measurement of extrinsic extension reserve
timeFrame: Baseline (day 0)
measure: EOS measurement of global extension reserve
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: Goniometric measurement of global extension reserve
timeFrame: baseline (day 0)
measure: Photographic measurement of global extension reserve
timeFrame: baseline (day 0)
measure: Roussouly classification: 1, 2, 3 or 4
timeFrame: baseline (day 0)
measure: Pelvic incidence (°)
timeFrame: Baseline (day 0)
measure: Standing sacral slope at rest
timeFrame: Baseline (day 0)
measure: Standing sacral slope in extension
timeFrame: Baseline (day 0)
measure: Standing pelvic tilt at rest
timeFrame: Baseline (day 0)
measure: Standing pelvic tilt in extension
timeFrame: Baseline (day 0)
measure: Standing anterior pelvic plane
timeFrame: Baseline (day 0)
measure: The front acetabular inclination while standing
timeFrame: Baseline (day 0)
measure: The sagittal acetabular inclination while standing
timeFrame: Baseline (day 0)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pascal Kouyoumdjian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: