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

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
SDS
MID-C
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Onset Scoliosis Deformity of Spine (Disorder) focused on measuring Growth friendly system, Distraction system, Early Onset Scoliosis, Unilateral

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amsterdam UMC
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Spring Distraction System

Minimal Invasive Deformity Correction system

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Limited-efficacy of SDS and MID-C in terms of spinal length
Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated Anterior Posterior (AP) X-rays post-op and at 4 weeks, 3 months and 12 months FU.
SDS vs. MID-C with respect to limited-efficacy in terms of curve correction maintenance
changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months FU. A maximum of 5 degrees increase will be the threshold to define maintenance.
SDS vs. MID-C with respect to limited-efficacy in terms of spinal length
Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated AP X-rays post-op and at 4 weeks, 3 months and 12 months FU.
SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events
Reported treatment related SAEs per-operatively and at 4 weeks, 3 months and 12 months FU.
SDS vs. MID-C with respect to surgery time
Surgery time in minutes
SDS vs. MID-C with respect to blood loss during surgery
blood loss in cc
SDS vs. MID-C with respect to length of hospital stay
length of hospital stay in days
SDS vs. MID-C with respect to recovery time
recovery time in minutes
SDS vs. MID-C with respect to bone density
Bone density changes of the bypassed vertebrae on Dual Energy X-ray Absorptiometry (DEXA)scan post-op and at 3 months en 12 months FU.
SDS vs. MID-C with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24)
Parent reported QOL and performance is assessed with the 24-item Early Onset Scoliosis Questionnaires (EOSQ-24) pre-op and at 4 weeks, 3 months and 12 months FU. EOSQ-24 covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items).
SDS vs. MID-C with respect to flexibility of the spine
Flexibility and 3D rotation of the spine on dynamic echography (Scolioscan)
SDS vs. MID-C with respect to 3D development of the spine
Apical Vertebral Rotation based on MRI
SDS vs. MID-C with respect to patient appearance
sagittal balance on clinical photographs post-op and at 1 year FU

Full Information

First Posted
June 7, 2019
Last Updated
March 18, 2020
Sponsor
UMC Utrecht
Collaborators
Apifix
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1. Study Identification

Unique Protocol Identification Number
NCT04003233
Brief Title
Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis
Acronym
UniPOWR
Official Title
Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the termination of the collaboration of ApiFix ltd. and the UMC Utrecht
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Apifix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Onset Scoliosis Deformity of Spine (Disorder), Idiopathic Scoliosis
Keywords
Growth friendly system, Distraction system, Early Onset Scoliosis, Unilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized and assigned to either SDS or MID-C.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spring Distraction System
Arm Type
Experimental
Arm Description
The SDS device will be implanted during a scoliosis correction operation.
Arm Title
Minimal Invasive Deformity Correction system
Arm Type
Experimental
Arm Description
The MID-C device will be implanted during a scoliosis correction operation.
Intervention Type
Device
Intervention Name(s)
SDS
Intervention Description
The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.
Intervention Type
Device
Intervention Name(s)
MID-C
Intervention Description
The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors
Primary Outcome Measure Information:
Title
Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle
Description
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.
Time Frame
Until 1 year post-operative FU
Title
Incidence of Treatment-Emergent Serious Adverse Events of SDS and MID-C
Description
Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months and 12 months FU.
Time Frame
Until 1 year post-operative FU
Secondary Outcome Measure Information:
Title
Limited-efficacy of SDS and MID-C in terms of spinal length
Description
Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated Anterior Posterior (AP) X-rays post-op and at 4 weeks, 3 months and 12 months FU.
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to limited-efficacy in terms of curve correction maintenance
Description
changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months FU. A maximum of 5 degrees increase will be the threshold to define maintenance.
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to limited-efficacy in terms of spinal length
Description
Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated AP X-rays post-op and at 4 weeks, 3 months and 12 months FU.
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events
Description
Reported treatment related SAEs per-operatively and at 4 weeks, 3 months and 12 months FU.
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to surgery time
Description
Surgery time in minutes
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to blood loss during surgery
Description
blood loss in cc
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to length of hospital stay
Description
length of hospital stay in days
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to recovery time
Description
recovery time in minutes
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to bone density
Description
Bone density changes of the bypassed vertebrae on Dual Energy X-ray Absorptiometry (DEXA)scan post-op and at 3 months en 12 months FU.
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24)
Description
Parent reported QOL and performance is assessed with the 24-item Early Onset Scoliosis Questionnaires (EOSQ-24) pre-op and at 4 weeks, 3 months and 12 months FU. EOSQ-24 covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items).
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to flexibility of the spine
Description
Flexibility and 3D rotation of the spine on dynamic echography (Scolioscan)
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to 3D development of the spine
Description
Apical Vertebral Rotation based on MRI
Time Frame
Until 1 year post-operative FU
Title
SDS vs. MID-C with respect to patient appearance
Description
sagittal balance on clinical photographs post-op and at 1 year FU
Time Frame
Until 1 year post-operative FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moyo C Kruyt, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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

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