Status:
COMPLETED
Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis
Lead Sponsor:
Lille Catholic University
Collaborating Sponsors:
SSR pédiatrique Marc Sautelet
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
FEMALE
12-17 years
Brief 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 specif...
Eligibility Criteria
Inclusion
- 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 neurological signs (signs of pyramidal irritation, sensory-motor deficit, clinical signs suggestive of cerebellar pathology ...)
- Known vestibular pathology
- Taking psychotropic drugs
- Additional exclusion criterion for the AIS group:
- Subject with secondary scoliosis : neurological, orthopedic, malformative...
- Additional criteria for the control group:
- Subject with a scoliosis angle ≥ 10° on a photogrammetric screening assessment (optical process, non-irradiating, which allows an Morphometric evaluation of the trunk in 3D, thanks to the analysis of the trunk reliefs)
- Subject whose clinical examination shows a gibbosity measurable (\>5°) with the scoliometer of Bunnel
Exclusion
Key Trial Info
Start Date :
February 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04760808
Start Date
February 10 2021
End Date
May 4 2022
Last Update
September 19 2024
Active Locations (2)
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1
SSR Pédiatrique Marc Sautelet
Villeneuve-d'Ascq, Nord (59), France, 59650
2
GHICL Hôpital Saint Philibert, service d'Imagerie Médicale
Lomme, Nord, France, 59462