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

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    28
  • sponsor
    UMC Utrecht
Updated on 4 June 2022

Summary

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.

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.

Details
Condition Neuromuscular Scoliosis, Distraction System, Growth Friendly System
Treatment SDS, NEMOST
Clinical Study IdentifierNCT04021784
SponsorUMC Utrecht
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
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