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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02299362
Date of registration:	18/11/2014
Prospective Registration:	No
Primary sponsor:	Growing Spine Study Group
Public title:	The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study GSSG
Scientific title:	The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
Date of first enrolment:	October 2008
Target sample size:	2602
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02299362
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Canada	Egypt	Ghana	Spain	Turkey	United Kingdom	United States

Contacts

Name:	Paul D Sponseller, MD, MBA
Address:
Telephone:
Email:
Affiliation:	Johns Hopkins Bloomberg Children's Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients of any age and any diagnosis who undergo a growth-friendly surgical
procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid
constructs, spinal tethering and staples

- Patients of any age and any diagnosis who undergo casting

- Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the
thoracic and/or lumbar spine

- Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic
and/or lumbar spine measuring > 25 degrees. Observed and braced patients included

Exclusion Criteria:

- Cervical spine anomalies alone will not be included

- Patient/family is unwilling to participate in the study

Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Infantile Idiopathic Scoliosis

Syndromic Spinal Deformity

Congenital Spinal Deformities

Neuromuscular Spinal Deformity

Early Onset Scoliosis

Thoracic Insufficiency Syndrome

Intervention(s)

Primary Outcome(s)

Clinical and Radiographic [Time Frame: 18 years]

Secondary Outcome(s)

Patient based outcomes [Time Frame: 18 years]

Secondary ID(s)

IRB-08055C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Growing Spine Foundation

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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