Post-market Clinical Follow-up Study of NEMOST V2

Cobb angle (°)

Comparison between preoperative measures, immediate postoperative measures and each visit measures. Measured on seated or standing anteroposterior and lateral X-ray images by identifying the most tilted vertebrae at the top and bottom of the spinal curve, drawing lines along their endplates, and calculating the angle formed by the intersection of perpendiculars to these lines. Normal value for Cobb angle is \<10° for no or benign scoliosis, medium scoliosis is defined between 15 and 35°, important scoliosis is defined as between 35 and 60° and very important scoliosis corresponds to angle \> 65°. The Cobb angle correction, used to compare pre and postoperative angle is defined as 100\*(preoperative value - postoperative value) / postoperative value.

Time frame: 5 years

Early-Onset Scoliosis questionnaire 24 items (EOSQ-24)

Considering clinical evaluation, the EOSQ-24 auto questionnaire addressed to patients' parents was selected. The 24-Item Early-onset Scoliosis Questionnaire (EOSQ-24) is a locally validated measurement tool to evaluate the overall impact of early onset scoliosis on patients' physical, psychological, and socio-economic well-being. Clinical results are assessed thanks to the EOSQ-24 quality of life questionnaire. It is divided in 11 themes, for which a score is calculated over 100. Each item is composed of 1 to 5 questions rated from 1 to 5, 5 being the best score. These scores will be between 0 to 100. Comparison between preoperative measures, immediate postoperative measures and each visit measures.

Time frame: 5 years

Pelvic obliquity (°)

Measured on seated or standing anteroposterior and lateral X-ray images by drawing a line between the iliac crests (or the inferior aspects of the sacroiliac joints) and calculating the angle between this line and a horizontal reference line. Normal value is 0°. Comparison between preoperative measures, immediate postoperative measures and each visit measures.

Time frame: 5 years

Thoracic kyphosis (°)

Measured on seated or standing anteroposterior and lateral X-ray images by calculating the Cobb angle between the superior endplate of the upper thoracic vertebra and the inferior endplate of the lower thoracic vertebra defining the kyphotic curve (commonly T4-T12). Comparison between preoperative measures, immediate postoperative measures and each visit measures.

Time frame: 5 years

Lumbar lordosis (°)

Measured on seated or standing anteroposterior and lateral X-ray images by calculating the Cobb angle between the superior endplate of the upper lumbar vertebra and the superior endplate of the sacrum (commonly L1-S1). Comparison between preoperative measures, immediate postoperative measures and each visit measures. Normal value ranges from 20 to 60°.

Time frame: 5 years

T1-T12 and T1-S1 length (mm)

T1-T12 length is measured on a standing or seated anteroposterior spinal radiograph as the linear distance between the midpoint of the superior endplate of T1 and the midpoint of the inferior endplate of T12. T1-S1 length is measured on a standing or seated anteroposterior spinal radiograph as the linear distance between the midpoint of the superior endplate of T1 and the midpoint of the superior endplate of S1. Comparison between preoperative measures, immediate postoperative measures and each visit measures.

Time frame: 5 years

Respiratory functional exploration

Pulmonary function testing is performed in a seated or supine position by measuring Total Lung Capacity (TLC, mL) and Vital Capacity (VC, mL) using standardized pulmonary function tests. Comparison between preoperative measures and each visit measures.

Time frame: 5 years