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

NCT ID: NCT04003233

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spring Distraction System

The SDS device will be implanted during a scoliosis correction operation.

Group Type: EXPERIMENTAL

SDS

Intervention Type: DEVICE

The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.

Minimal Invasive Deformity Correction system

The MID-C device will be implanted during a scoliosis correction operation.

Group Type: EXPERIMENTAL

MID-C

Intervention Type: DEVICE

The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors

Interventions

SDS

The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.

Intervention Type: DEVICE

MID-C

The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray
• Scoliosis diagnosis prior to the age 10
• Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)
• Progressive scoliosis qualified for growth system surgery
• One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2
• The primary curve must be between 35 and 75 degrees coronal Cobb angle
• The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or reduces >30% )
• Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays

Exclusion Criteria

• Patients with an obvious neuromuscular disease
• Patients that are severely mentally retarded
• Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
• Patients with a main curve of more than 8 vertebra Cobb to Cobb
• Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
• Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
• Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
• Patients with an active systemic disease such as Juvenile Idiopathic Arthritis, HIV or oncologic treatment
• Patients with a previous surgical fusion of the spine

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apifix

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

M.C. Kruyt, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moyo C Kruyt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

Amsterdam UMC

Amsterdam, North Holland, Netherlands

UMC Utrecht

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

NL63511.041.17

Identifier Type: -

Identifier Source: org_study_id