NCT04003233

Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Detailed description

Rationale: EOS is a severe and potentially life-threatening disorder since a disturbance of spinal development leads to impaired development of the trunk, with cardio-respiratory failure as a result, often early in adult life. Several innovative solutions have been developed to treat growing children with severe EOS. The SDS device was developed internally at the dpt. of orthopedics at the UMC Utrecht, the Netherlands, the MID-C device was developed by the company ApiFix Ltd. Objective: The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of early onset scoliosis in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety. Study design: A feasibility study using two prospective cohorts according to an open label randomized clinical trial (RCT) design. The study will be done in two tertiary referral centers (UMC Utrecht and Amsterdam UMC). Primary endpoints are maintenance of curve correction as well as complications. These data will be compared to a recently described cohort of patients that received a "standard treatment" (Magnetically controlled growing rod (MCGR)). The same endpoints as well as secondary outcomes, will be compared between the two new treatments. Study population: Children with idiopathic(-like) early onset scoliosis with an indication for a growing rod implant.

Conditions

• Early-Onset Scoliosis Deformity of Spine (Disorder)
• Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	SDS	The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.
DEVICE	MID-C	The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2019-07-01
• Last updated: 2020-03-23

Locations

2 sites across 1 country: Netherlands