Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Qualifiers

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

Treatments tested in this trial

  • NEMOST system

Treatment groups

18 Participants
are divided into 1 treatment group