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Casting vs Bracing for Idiopathic Early-Onset Scoliosis (CVBT)

Primary Purpose

Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Casting
Bracing
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring Cast, Brace, Spinal Orthosis, Spinal Orthotic

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Will enroll both patients with scoliosis and 1 of their parents/guardians

Inclusion Criteria:

Patient Inclusion

  • Diagnosis of idiopathic early-onset scoliosis
  • Child standing independently but not older than 3 years of age
  • 20≤ Cobb angle ≤70° (largest structural curvature)
  • Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
  • Parental consent to participate

Parent Inclusion

  • Parent or guardian of the minor subject
  • Consent to participate
  • Able to complete surveys

Exclusion Criteria:

Patient Exclusion

  • Previous operative or non-operative treatment for idiopathic early-onset scoliosis
  • Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay

Sites / Locations

  • Arkansas Children's HospitalRecruiting
  • Children's Hospital ColoradoRecruiting
  • Nemours/Alfred I. duPont Hospital for ChildrenRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Lurie Children's Hospital of ChicagoRecruiting
  • Shriners Hospitals for Children - ChicagoRecruiting
  • Riley's Hospital for Children at IU HealthcareRecruiting
  • University of IowaRecruiting
  • Johns HopkinsRecruiting
  • Children's Hospital of BostonRecruiting
  • University of MichiganRecruiting
  • Gillette Children's Specialty HealthcareRecruiting
  • Children's Mercy Kansas CityRecruiting
  • St. Louis Children's Hospital/Washington UniversityRecruiting
  • Morgan Stanley Children's HospitalRecruiting
  • Golisano Children's Hospital/University of RochesterRecruiting
  • University of North Carolina Chapel HillRecruiting
  • Duke University Medical Center
  • Doernbecher Children's Hospital / OHSURecruiting
  • Shriners Hospitals for Children - PortlandRecruiting
  • Children's Hospital of PennsylvaniaRecruiting
  • Shriners Hospitals for Children - PhiladelphiaRecruiting
  • Children's Hospital of PittsburghRecruiting
  • Campbell Clinic/Le Bonheur Children's HospitalRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Texas Children's HospitalRecruiting
  • University of VirginiaRecruiting
  • Seattle Children's HospitalRecruiting
  • Children's Hospital of WisconsinRecruiting
  • British Columbia Children's HospitalRecruiting
  • IWK Health Centre
  • CHU Sainte-JustineRecruiting
  • University of Hong KongRecruiting
  • Italian Scientific Spine Institute (ISICO)Recruiting
  • Starship Child HealthRecruiting
  • National University HospitalRecruiting
  • Acibadem Maslak Hospital
  • Royal Orthopaedic HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Casting

Bracing

Arm Description

Subjects will be treated with serial casting

Subjects will be treated with full-time orthotics (braces)

Outcomes

Primary Outcome Measures

Curve Response
Resolution - curve improvement to <15 degrees (as measured on 2 consecutive radiographs) Failure Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50° Initial Cobb >50°: curve progression of ≥20° Palliation - 2 years of treatment without resolution or failure

Secondary Outcome Measures

Patient Health-related Quality of Life (HRQOL)
Evaluation of patients' HRQOL as estimated by serial administrations of the Early Onset Scoliosis Questionnaire (EOSQ-24, completed by the parent at baseline and every 6 months, total score range 0-100, higher scores indicate higher level of HRQOL). Within and between treatment arm comparisons will be made.

Full Information

First Posted
July 31, 2020
Last Updated
October 5, 2022
Sponsor
University of Iowa
Collaborators
Orthopedic Research and Education Foundation, Pediatric Spine Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT04500041
Brief Title
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Acronym
CVBT
Official Title
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Orthopedic Research and Education Foundation, Pediatric Spine Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Detailed Description
This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine
Keywords
Cast, Brace, Spinal Orthosis, Spinal Orthotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment (casting or bracing) via randomized assignment OR based on family preference
Masking
Outcomes Assessor
Masking Description
Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Casting
Arm Type
Active Comparator
Arm Description
Subjects will be treated with serial casting
Arm Title
Bracing
Arm Type
Active Comparator
Arm Description
Subjects will be treated with full-time orthotics (braces)
Intervention Type
Procedure
Intervention Name(s)
Casting
Intervention Description
Use of casts applied using corrective maneuvers
Intervention Type
Device
Intervention Name(s)
Bracing
Intervention Description
Use of full-time spinal orthosis
Primary Outcome Measure Information:
Title
Curve Response
Description
Resolution - curve improvement to <15 degrees (as measured on 2 consecutive radiographs) Failure Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50° Initial Cobb >50°: curve progression of ≥20° Palliation - 2 years of treatment without resolution or failure
Time Frame
on or before 24 months of treatment
Secondary Outcome Measure Information:
Title
Patient Health-related Quality of Life (HRQOL)
Description
Evaluation of patients' HRQOL as estimated by serial administrations of the Early Onset Scoliosis Questionnaire (EOSQ-24, completed by the parent at baseline and every 6 months, total score range 0-100, higher scores indicate higher level of HRQOL). Within and between treatment arm comparisons will be made.
Time Frame
on or before 24 months of treatment
Other Pre-specified Outcome Measures:
Title
Parent and Family Functioning
Description
Evaluation of patients' disease and treatment on parent and family function as estimated by serial administrations of the PedsQL Family Impact Module scores (PedsQL FIM, completed by the parent, total score range 0-100, higher scores indicate less negative impact). Within and between treatment arm comparisons will be made.
Time Frame
on or before 24 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Will enroll both patients with scoliosis and 1 of their parents/guardians Inclusion Criteria: Patient Inclusion Diagnosis of idiopathic early-onset scoliosis Child standing independently but not older than 3 years of age 20≤ Cobb angle ≤70° (largest structural curvature) Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II Parental consent to participate Parent Inclusion Parent or guardian of the minor subject Consent to participate Able to complete surveys Exclusion Criteria: Patient Exclusion Previous operative or non-operative treatment for idiopathic early-onset scoliosis Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori A Dolan, PhD
Phone
319-356-1075
Email
lori-dolan@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart L Weinstein, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Ford
Email
fordjr@archildrens.org
First Name & Middle Initial & Last Name & Degree
David Bumpass, MD
First Name & Middle Initial & Last Name & Degree
Richard McCarthy, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler Feddema
Email
tyler.feddema@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Sumeet Garg, MD
First Name & Middle Initial & Last Name & Degree
Mark Erickson, MD
Facility Name
Nemours/Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petya Yorgova
Email
petya.yorgova@nemours.org
First Name & Middle Initial & Last Name & Degree
Suken Shah, MD
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Numera Sachwani
Email
numera.sachwani@choa.org
First Name & Middle Initial & Last Name & Degree
Michael Schmidt, MD
First Name & Middle Initial & Last Name & Degree
Dennis Devito, MD
First Name & Middle Initial & Last Name & Degree
Nicholas Fletcher, MD
First Name & Middle Initial & Last Name & Degree
Joshua Murphy, MD
Facility Name
Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Wild
Email
jwild@luriehildrens.org
First Name & Middle Initial & Last Name & Degree
John Sarwark, MD
First Name & Middle Initial & Last Name & Degree
John Grayhack, MD
Facility Name
Shriners Hospitals for Children - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Schlotter
Email
jschottler@shrinenet.org
First Name & Middle Initial & Last Name & Degree
Purnendu Gupta, MD
First Name & Middle Initial & Last Name & Degree
Kim Hammerberg, MD
First Name & Middle Initial & Last Name & Degree
Michal Szczodry, MD
Facility Name
Riley's Hospital for Children at IU Healthcare
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Moore
Email
momfreed@iupui.edu
First Name & Middle Initial & Last Name & Degree
Tyler Christman, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori A Dolan, PhD
Phone
319-356-1075
Email
lori-dolan@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Stuart L Weinstein, MD
First Name & Middle Initial & Last Name & Degree
Lori A Dolan, PhD
First Name & Middle Initial & Last Name & Degree
Joshua Holt, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Reichard
Email
greicha1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Paul Sponseller, MD
Facility Name
Children's Hospital of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney Lee
Email
sydney.lee@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Timothy Hresko, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahil Jha
Email
sahiljha@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Ying Li, MD
Facility Name
Gillette Children's Specialty Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Morgan
Email
sarajmorgan@gillettechildrens.com
First Name & Middle Initial & Last Name & Degree
Daniel Miller, MD
First Name & Middle Initial & Last Name & Degree
Eduardo Beauchamp, MD
First Name & Middle Initial & Last Name & Degree
Tenner Guillaume, MD
First Name & Middle Initial & Last Name & Degree
Steven Koop, MD
First Name & Middle Initial & Last Name & Degree
Joseph Perra, MD
First Name & Middle Initial & Last Name & Degree
Walter Truong, MD
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Leamon
Email
jleamon@cmh.edu
First Name & Middle Initial & Last Name & Degree
Richard Schwend, MD
First Name & Middle Initial & Last Name & Degree
John Anderson, MD
Facility Name
St. Louis Children's Hospital/Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Brouillet
Email
kbrouillet@wustl.edu
First Name & Middle Initial & Last Name & Degree
Brian Kelly, MD
First Name & Middle Initial & Last Name & Degree
Scott Luhmann, MD
Facility Name
Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afrain Boby
Email
ab4789@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Roye, MD
First Name & Middle Initial & Last Name & Degree
Michael Vitale, MD
Facility Name
Golisano Children's Hospital/University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Hoffman
Email
samantha_hoffman@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Susan Nelson, MD
First Name & Middle Initial & Last Name & Degree
Paul Rubery, MD
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Titter
Email
julie_titter@med.unc.edu
First Name & Middle Initial & Last Name & Degree
James Sanders, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Doernbecher Children's Hospital / OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Smith
Email
smithreb@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Matthew Halsey, MD
First Name & Middle Initial & Last Name & Degree
Scott Yang, MD
Facility Name
Shriners Hospitals for Children - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Louie
Email
david.louie@shrinenet.org
First Name & Middle Initial & Last Name & Degree
Michelle Welborn, MD
First Name & Middle Initial & Last Name & Degree
Daniel Bouton, MD
Facility Name
Children's Hospital of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leta Ashebo
Email
ashebol@chop.edu
First Name & Middle Initial & Last Name & Degree
Patrick Cahill, MD
Facility Name
Shriners Hospitals for Children - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Woloff
Email
Jason.Woloff@shrinenet.org
First Name & Middle Initial & Last Name & Degree
Joshua Pahys, MD
First Name & Middle Initial & Last Name & Degree
Amir Samdani, MD
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Novak
Email
novakne@upmc.edu
First Name & Middle Initial & Last Name & Degree
Timothy Ward, MD
First Name & Middle Initial & Last Name & Degree
Patrick Bosch, MD
First Name & Middle Initial & Last Name & Degree
Ozgur Dede, MD
First Name & Middle Initial & Last Name & Degree
Stephen Mendelson, MD
Facility Name
Campbell Clinic/Le Bonheur Children's Hospital
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rowland
Email
jrowland@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Derek Kelly, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brook Turner
Email
brooke.turner@vumc.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Martus, MD
First Name & Middle Initial & Last Name & Degree
Gregory Mencio, MD
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Callie Bridges
Email
csbridg2@texaschildrens.org
First Name & Middle Initial & Last Name & Degree
Brian Smith, MD
First Name & Middle Initial & Last Name & Degree
Benny Dahl, MD
First Name & Middle Initial & Last Name & Degree
Frank Gerow, MD
First Name & Middle Initial & Last Name & Degree
Darrell Hanson, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy McKnight
Email
hhz8fz@hscmail.mcc.virginia.eduginia.edu
First Name & Middle Initial & Last Name & Degree
Keith Bachmann, MD
First Name & Middle Initial & Last Name & Degree
Mark Abel, MD
First Name & Middle Initial & Last Name & Degree
Anuj Singla, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Varakitsomboon Shing
Email
shing.varakitsomboon@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Klane White, MD
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Giebel
Email
ngiebel@mcw.edu
First Name & Middle Initial & Last Name & Degree
John Thometz, MD
First Name & Middle Initial & Last Name & Degree
Xue-Cheng Liu, MD
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garshana Rajkumar
Email
garshana.rajkumar@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Sachini Jaysinghe
Email
sachini.jayasinghe1@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji, MD
First Name & Middle Initial & Last Name & Degree
Christopher Reilly, MD
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Bouchard
Email
mandy.bouchard@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Ron El-Hawary, MD
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Turgeon
Email
isabelle.turgeon.hsj@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Stefan Parent, MD
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giselle Li
Email
gdli21@ortho.hku.hk
First Name & Middle Initial & Last Name & Degree
Kenneth Cheung, MD
First Name & Middle Initial & Last Name & Degree
Jason Cheung, MD
First Name & Middle Initial & Last Name & Degree
Kenny Kwan, MD
First Name & Middle Initial & Last Name & Degree
Graham Shea, MD
Facility Name
Italian Scientific Spine Institute (ISICO)
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Donzelli
Email
sabrina.donzelli@isico.it
First Name & Middle Initial & Last Name & Degree
Stefano Negrini, MD
First Name & Middle Initial & Last Name & Degree
Sabrina Donzelli, MD
First Name & Middle Initial & Last Name & Degree
Fabio Zaina, MD
Facility Name
Starship Child Health
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuela Crua
Email
emanuela@abjs.co.nz
First Name & Middle Initial & Last Name & Degree
Haemish Crawford, MD
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Chew
Email
Jeremy_JE_CHEW@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Hee Kit Wong, MBBS
First Name & Middle Initial & Last Name & Degree
Loek Lim Lau, MBBS
Facility Name
Acibadem Maslak Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tais Zulemyan
Email
tais.zulemyan@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmet Alanay, MD
First Name & Middle Initial & Last Name & Degree
Yilgor Caglor, MD
Facility Name
Royal Orthopaedic Hospital
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Pinner
Email
craig.pinner@nhs.net
First Name & Middle Initial & Last Name & Degree
Adrian Gardner, MB, FRCS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All study data (assessments and images) will reside in the Pediatric Spine Registry.
IPD Sharing Time Frame
after our planned analyses and publications are completed
IPD Sharing Access Criteria
Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.

Learn more about this trial

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

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