- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909258
Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods (CRESPEOS)
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 Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- CHU de Montpellier - Hôpital Lapeyronie
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Nîmes Cedex 9, France, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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 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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EOS measurement of intrinsic reserve extension = angular variation of the sacral slope (left and right sides)
Time Frame: baseline (day 0)
|
= RIEeos
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baseline (day 0)
|
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)
|
Baseline (day 0)
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EOS measurement of global extension reserve
Time Frame: Baseline (day 0)
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= RIEeos + REEeos (left and right sides)
|
Baseline (day 0)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goniometric measurement of global extension reserve
Time Frame: baseline (day 0)
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(left and right sides)
|
baseline (day 0)
|
Photographic measurement of global extension reserve
Time Frame: baseline (day 0)
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(left and right sides)
|
baseline (day 0)
|
Roussouly classification: 1, 2, 3 or 4
Time Frame: baseline (day 0)
|
baseline (day 0)
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|
Pelvic incidence (°)
Time Frame: Baseline (day 0)
|
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)
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Standing sacral slope at rest
Time Frame: Baseline (day 0)
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Baseline (day 0)
|
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Standing sacral slope in extension
Time Frame: Baseline (day 0)
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Baseline (day 0)
|
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Standing pelvic tilt at rest
Time Frame: Baseline (day 0)
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Baseline (day 0)
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Standing pelvic tilt in extension
Time Frame: Baseline (day 0)
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Baseline (day 0)
|
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Standing anterior pelvic plane
Time Frame: Baseline (day 0)
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Baseline (day 0)
|
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The front acetabular inclination while standing
Time Frame: Baseline (day 0)
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Baseline (day 0)
|
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The sagittal acetabular inclination while standing
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pascal Kouyoumdjian, MD, PhD, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AOI/2012/PK
- 2013-A00232-43 (Other Identifier: RCB number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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