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

NCT ID: NCT01909258

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-25

Brief Summary

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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

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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

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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The study population.

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.

Group Type EXPERIMENTAL

Goniometric measure of pelvic extension reserve.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type OTHER

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).

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal Kouyoumdjian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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Kouyoumdjian P, Mansour J, Haignere V, Demattei C, Maury E, George D, Coulomb R. Hip-Spine Relationship between Sagittal Balance of the Lumbo-Pelvi-Femoral Complex and Hip Extension Capacity: An EOS Evaluation in a Healthy Caucasian Population. Global Spine J. 2024 Jan;14(1):265-271. doi: 10.1177/21925682221103831. Epub 2022 May 23.

Reference Type RESULT
PMID: 35604878 (View on PubMed)

Other Identifiers

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AOI/2012/PK

Identifier Type: -

Identifier Source: org_study_id

2013-A00232-43

Identifier Type: OTHER

Identifier Source: secondary_id