Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients — NEMOST-AIS  

Adolescent Idiopathic Scoliosis Clinical Trial

Official title: Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

• NCT number: NCT04441411
• Study type: Interventional
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: BJ Van Royen, MD, PhD
• Phone: +31(0)5662672
• Email: bj.vanroyen@amsterdamumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Completion date: December 31, 2023