Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis
Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis
The primary aim of this study is to investigate the limited efficacy of the Spring
 Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction
 without repeat lengthening procedures and complications. Secondary aims are to investigate
 growth of the instrumented spine and to compare these devices.
Several innovative solutions have been developed to treat growing children with a severe
 scoliosis. One device (SDS) was developed internally at the department of orthopaedics UMC
 Utrecht in the Netherlands. The other device (NEMOST) was developed at the Necker Hospital in
 France.

 This study is designed as a multicenter, limited-efficacy study using two prospective cohorts
 according a randomised clinical trial. The study will be done in two centers (UMC Utrecht and
 Amsterdam UMC).

 The primary endpoints are the limited-efficacy in terms of maintenance of curve correction
 and occurrence of SAEs related to the procedure. These data will be compared to a recently
 described cohort of patients that received a "standard treatment", the MGCR (Skov et al.,
 2017). Secondary endpoints include patient performance based on the EOSQ 24 and Lenke
 questionnaire, surgical parameters, maintenance of curve mobility by using ultrasound and
 pulmonary function
Inclusion Criteria:

 -  Non ambulant

 -  Neuromuscular or syndromal scoliosis

 -  Progressive scoliosis indicated for bipolar fixation extending to the pelvis

 -  Diagnosis of scoliosis before age 10

 -  Patient under 12 and open triradiate cartilage (usually closes around 12 years for
 girls and 14 years for boys)

 -  Main curve proximal end vertebra below Th 3

 -  Non rigid curve (at least 25% decrease on bending X rays)

 -  Patients who have an indication for a primary surgery

 Exclusion Criteria:

 -  Ambulant

 -  Patients with closed triradiate cartilage

 -  Patients with a skeletal dysplasia that effects growth (Achondroplasia, SED)

 -  Patients with a systemic disease which severely influences bone quality e.g.
 osteogenesis imperfecta, metabolic diseases

 -  Patients with soft tissue weakness (Ehler Danlos, Marfan, Neurofibromatosis, Prader
 Willi)

 -  Patients that have a congenital anomaly of the spine of more than 5 vertebrae

 -  Patients with an active systemic disease such as JIA, HIV, oncologic treatment

 -  Patients with a previous surgical fusion of the spine

 -  Patients that are expected to be lost to FU due to e.g. likely to immigrate within 1
 year.

 -  Patients that have had a previous spine surgery.