About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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);
Trial design
Single group
Treatments tested in this trial
NEMOST system
DeviceMinimal invasive double rod posterior Non-Fusion Scoliosis Surgery
Treatment groups
Trial outcomes
Primary outcomes
Coronal balance (Correction of the primary curvature on radiograph
Cobb angle (degrees)
T1-S1 length on radiograph
length (cm)
instrument segment length on radiograph
length (cm)
(Serious) Adverse Event
complications
Secondary outcomes
Vertebral rotation
scoliometer assesment
Patient Reported Outcome (PRO
Scoliosis Research Society's-22 questionnaire
Sponsors and contacts
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