on Fusion Surgery in Adolescent Idiopathic Scoliosis patients using the Nemost-AIS system

not applicable0 个研究点目标入组 28 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•Diagnosis of idiopathic scoliosis ;
•-Primary Cobb angle greater than 30°;
•-Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time;
•-Skeletally immature (Risser grade* =1 and Skeletal age of hand and wrist X-rays =14y);
•-In girls, either pre-menarchal or post-menarchal by no more than 1 year;
•-Age over 7 years;
•-Non rigid curve;
•-All Lenke type;
•-No previous spine surgery.

•-Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);
•-History of previous spine surgery;
•-Risser sign >1;
•-Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality);
•-Non-reductible scoliosis;
•-Known allergy or intolerance to one of the device material;
•-Acute or chronic infections, local or systemic;
•-Absence or insufficience of covering tissues;
•-Pathological obesity.

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