Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
The primary objective of the study is to monitor the effectiveness of a minimal invasive
 non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the
 scoliotic curve in growing patients suffering from progressive adolescent idiopathic
 scoliosis (AIS) who have failed conservative treatment.
Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in
 growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is
 unknown. Children with severe and progressive scoliosis, if left untreated, are at risk of
 rapid and severe spinal deformity progression, which can result in a decrease of pulmonary
 function, poor cosmetic result and poor quality of life.

 Treatment options in AIS depend on curve severity and remaining growth potential, and include
 intensive brace treatment for smaller curvatures whereas surgical correction and spinal
 fusion is advocated for more severe curves. Growing rods are used for severe early infantile
 deformities or early onset scoliosis (EOS).

 Bracing, by using a rigid plastic orthosis, is currently the primary therapy to prevent curve
 progression in mild curves up to 45 degrees and skeletal immature patients. Most braces are
 recommended to be worn for 18-23 hours per day during several years (until skeletal maturity
 has been reached). This may cause a high level of physical discomfort and emotional and
 psychological stress in these patients, and failure of brace treatment therefore is common.

 Surgical therapy for AIS is recommended in severe progressive curvatures. Surgical treatment
 includes correction of the spinal curvature by using multisegmental screw fixation and
 posterior spinal fusion of the thoracolumbar spine. Complete posterior spinal fusion,
 however, lacks the possibilities for future adaptation of natural changes in spinal balance
 and posture.

 Currently, growing rods systems are used as a posterior spinal implant to allow growth of the
 spine and thorax and limit progression of the scoliosis in young patients with early onset
 scoliosis. Growing rods systems are distractible spinal implants, with bipolar anchorage
 fixations to the upper and lower part of the spine, using posterior spinal instrumentation
 such as hooks and pedicle screws.

 The Nemost growing system, developed by the EUROS Compagny, is a CE-marked commercial
 available medical device for the treatment of early onset neuromuscular or early onset
 idiopathic scoliosis. It is a non-fusion, growth enabling system with bipolar fixation
 intended to be used with a posterior spinal instrumentation.

 It is hypothesized that the use of a minimal invasive non-fusion bipolar posterior spinal
 implant (Nemost growing domino) can both correct and brace the spine internally and adapt
 balans and or distraction as the idiopathic scoliosis patient grows.
Inclusion Criteria:

 -  Adolescent 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 girl, either pre-menarchal or post-menarchal by no more than 1 year;

 -  Age over 10 years;

 -  Non rigid curve;

 -  All Lenke type;

 -  No previous spine surgery.

 Exclusion Criteria:

 -  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.