NEMOST system: Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery
Study summary
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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
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\* ≤2 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 \>2;
* 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.
Primary outcome measure(s)
Coronal balance (Correction of the primary curvature on radiograph — 2 years Cobb angle (degrees)
T1-S1 length on radiograph — 2 years length (cm)
instrument segment length on radiograph — 2 years length (cm)
(Serious) Adverse Event — 2 years complications
Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle) — 2 years Cobb angle (degrees)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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