Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis (NCT04760808) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis
France72 participantsStarted 2021-02-10
Plain-language summary
Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. More specifically a modification of the cerebro-spinal fluid (CSF) flow by ciliary dysfunction could be at the origin of a scoliotic deformity.
This study aims to compare the CSF flow measured by magnetic resonance imaging (MRI) in an AIS group and a control group.
Who can participate
Age range12 Years – 17 Years
SexFEMALE
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Common Inclusion Criteria for the 2 groups :
* Female subject aged 12 to \< 18 years old
* Affiliated to the French social security system
* Having signed the inform consent form
* Whose parents have given their consent
Additional Inclusion Criteria for the AIS group:
* Subject with right thoracic AIS defined by the existence of a 3D spine deformation with a frontal deviation to right dorsal convexity with a Cobb angle of at least 20°, and a rotation of at least 20°, as evidenced by the presence of a vertebral gibbosity ≥ 5° at the Bunnel scoliometer.
If the scoliosis has more than one curvature, the right chest curvature should be the greatest high (highest frontal Cobb angle)
* Subject with x-rays of total spine, face and profile under load, according to the EOS technique, dating from less than 3 months.
Common Exclusion Criteria for the 2 groups:
* Instability to submit to the medical follow-up of the study for psychic, social or geographical reasons
* At least 6 "cafe au lait" spots with a size ≥ 1.5 cm (may be suggestive of neurofibromatosis)
* Ligament hyperlaxity confirmed by a Beighton score \>4/9 (which may be suggestive of scoliosis secondary)
* Contraindications of a cerebro-medullary MRI: claustrophobia, foreign bodies, and ferrometallic clips of the trunk or cephalic segment, cochlear implants, stimulators and implantable cardiac defibrillators, insulin pump
* Inequality in length of the lower limbs ≥ 20 mm on clinical examination
* Subject presenting neur…