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

NCT04003233 | Withdrawn DMC

• 1 other identifier: NL63511.041.17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Growth friendly system; Distraction system; Early Onset Scoliosis; Unilateral

Outcome Measures

Primary Outcomes (2)

• Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle

  changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance.

  Until 1 year post-operative FU

• Incidence of Treatment-Emergent Serious Adverse Events of SDS and MID-C

  Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months and 12 months FU.

  Until 1 year post-operative FU

Secondary Outcomes (13)

• Limited-efficacy of SDS and MID-C in terms of spinal length

  Until 1 year post-operative FU

• SDS vs. MID-C with respect to limited-efficacy in terms of curve correction maintenance

  Until 1 year post-operative FU

• SDS vs. MID-C with respect to limited-efficacy in terms of spinal length

  Until 1 year post-operative FU

• SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events

  Until 1 year post-operative FU

• SDS vs. MID-C with respect to surgery time

  Until 1 year post-operative FU

Study Arms (2)

Spring Distraction System

EXPERIMENTAL

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

Device: SDS

Minimal Invasive Deformity Correction system

EXPERIMENTAL

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

Device: MID-C

Interventions

SDS DEVICE

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

Spring Distraction System

MID-C DEVICE

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

Minimal Invasive Deformity Correction system

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Apifix: collaborator

Study Sites (2)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Study Officials

• Moyo C Kruyt, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the medical device till the surgery. After the surgery participants are able to see which medical device is implanted on X-rays.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized and assigned to either SDS or MID-C.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: July 1, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)