Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis (BiPOWR)

UMC Utrecht

Status: Completed

Conditions: Neuromuscular Scoliosis; Growth Friendly System; Distraction System

Treatments: Device: SDS; Device: NEMOST

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04021784

NL 64018.041.17

Details and patient eligibility

About

The primary aim of this study is to investigate and describe 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 describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

Full description

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 performed in two centers (UMC Utrecht, Amsterdam UMC and Erasmus MC).

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 spinal- and implant growth, patient performance based on the EOSQ 24 questionnaire and surgical parameters.

Enrollment: 28 patients

Sex: All

Volunteers: No Healthy Volunteers

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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Spring Distraction System (SDS)

Experimental group

Description:

The SDS will be placed and fits around a standard rod of 5.5mm.

Treatment:

Device: SDS

Necker Enfants Malade OSTeosynthesis (NEMOST)

Experimental group

Description:

The NEMOST is a one-way-rod that uses a ratchet type of locking mechanism. Both NEMOST devices should be placed in parallel, on the two fixator rods that are connected with a cross connector

Treatment:

Device: NEMOST