Healthy VolunteerCRESPEOSNCT01909258
Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods
A study testing Goniometric measure of pelvic extension reserve., Photographic measure of pelvic extension reserve. and EOS measure of pelvic extension reserve. in people with Healthy Volunteer, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Goniometric measure of pelvic extension reserve., Photographic measure of pelvic extension reserve. and EOS measure of pelvic extension reserve.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2015to 25 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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
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.
Read the detailed description
Secondary objectives:
- 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.
- The concordance between EOS measurements and measurements acquired via goniometry and photography will be evaluated.
- Describe certain radiographic measurements via the EOS system for the four morphotypes
- Conditions
- Healthy Volunteer
- Being tested
- Goniometric measure of pelvic extension reserve., Photographic measure of pelvic extension reserve., EOS measure of pelvic extension reserve.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goniometric measure of pelvic extension reserve.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.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.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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Goniometric measure of pelvic extension reserve.; Other: Photographic measure of pelvic extension reserve.; Other: EOS measure of pelvic extension reserve. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)
= RIEeos
Measured: 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)
Measured: Baseline (day 0)
EOS measurement of global extension reserve
= RIEeos + REEeos (left and right sides)
Measured: Baseline (day 0)
Secondary outcomes (11)
Goniometric measurement of global extension reserve
(left and right sides)
Measured: baseline (day 0)
Photographic measurement of global extension reserve
(left and right sides)
Measured: baseline (day 0)
Roussouly classification: 1, 2, 3 or 4
Measured: baseline (day 0)
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.
Measured: Baseline (day 0)
Standing sacral slope at rest
Measured: Baseline (day 0)
Standing sacral slope in extension
Measured: Baseline (day 0)
Standing pelvic tilt at rest
Measured: Baseline (day 0)
Standing pelvic tilt in extension
Measured: Baseline (day 0)
Standing anterior pelvic plane
Measured: Baseline (day 0)
The front acetabular inclination while standing
Measured: Baseline (day 0)
The sagittal acetabular inclination while standing
Measured: Baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJan 2015
- Primary completion25 Apr 2016
- Study completion25 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Kouyoumdjian, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909258
- Sponsor's protocol ID
- AOI/2012/PK
- Other IDs
- 2013-A00232-43
- Acronym
- CRESPEOS
- Status last verified
- May 2016
- First submitted
- 18 Jul 2013
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35604878
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01909258
- Acronym / sponsor ID
- CRESPEOS / AOI/2012/PK
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 25 Apr 2016 (actual)
- Study completion
- 25 Apr 2016 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The concordance between EOS measurements and measurements acquired via goniometry and photography will be evaluated.
- Describe certain radiographic measurements via the EOS system for the four morphotypes
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population. | Experimental | Other: Goniometric measure of pelvic extension reserve., Other: Photographic measure of pelvic extension reserve., Other: 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | The study population. |
| 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). | Other | The study population. |
| 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. | Other | The study population. |
Primary outcome
EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)
Time frame: baseline (day 0)
= RIEeos
EOS measurement of extrinsic extension reserve
Time frame: 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
Time frame: Baseline (day 0)
= RIEeos + REEeos (left and right sides)
11 secondary outcomes
Goniometric measurement of global extension reserve
Time frame: baseline (day 0)
Photographic measurement of global extension reserve
Time frame: baseline (day 0)
Roussouly classification: 1, 2, 3 or 4
Time frame: baseline (day 0)
Pelvic incidence (°)
Time frame: Baseline (day 0)
Standing sacral slope at rest
Time frame: Baseline (day 0)
Standing sacral slope in extension
Time frame: Baseline (day 0)
Standing pelvic tilt at rest
Time frame: Baseline (day 0)
Standing pelvic tilt in extension
Time frame: Baseline (day 0)
Standing anterior pelvic plane
Time frame: Baseline (day 0)
The front acetabular inclination while standing
Time frame: Baseline (day 0)
The sagittal acetabular inclination while standing
Time frame: Baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 35604878Kouyoumdjian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Kouyoumdjian, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goniometric measure of pelvic extension reserve., Photographic measure of pelvic extension reserve. and EOS measure of pelvic extension reserve. in people with Healthy Volunteer, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides) (time frame: baseline (day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.