NCT04021784

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

Limited-efficacy Testing of Spring Distraction System (SDS) and a Bilateral One Way Rod (NEMOST) for Early Onset Neuromuscular Scoliosis (BiPOWR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neuromuscular Scoliosis
• Distraction System
• Growth Friendly System

Interventions

Type	Name	Description
DEVICE	SDS	The patient is implanted with SDS.
DEVICE	NEMOST	The patient is implanted with NEMOST.

Timeline

• Start date: 2019-05-06
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2019-07-16
• Last updated: 2023-06-05

Locations

3 sites across 1 country: Netherlands