NCT01909258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2016

Completed
Last Updated

December 22, 2025

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

July 18, 2013

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)

    = RIEeos

    baseline (day 0)

  • 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)

  • EOS measurement of global extension reserve

    = RIEeos + REEeos (left and right sides)

    Baseline (day 0)

Secondary Outcomes (11)

  • Goniometric measurement of global extension reserve

    baseline (day 0)

  • Photographic measurement of global extension reserve

    baseline (day 0)

  • Roussouly classification: 1, 2, 3 or 4

    baseline (day 0)

  • Pelvic incidence (°)

    Baseline (day 0)

  • Standing sacral slope at rest

    Baseline (day 0)

  • +6 more secondary outcomes

Study Arms (1)

The study population.

EXPERIMENTAL

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.

Other: Goniometric measure of pelvic extension reserve.Other: Photographic measure of pelvic extension reserve.Other: EOS measure of pelvic extension reserve.

Interventions

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).

The study population.

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).

The study population.

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.

The study population.

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • The healthy volunteer is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

Study Officials

  • Pascal Kouyoumdjian, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 26, 2013

Study Start

January 1, 2015

Primary Completion

April 25, 2016

Study Completion

April 25, 2016

Last Updated

December 22, 2025

Record last verified: 2016-05

Locations