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Long-Term Follow-Up Of Surgical Management Of Early Onset Scoliosis Using Growing Rods

Primary Purpose

Early-Onset Scoliosis Deformity of Spine

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Growing Rods
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Onset Scoliosis Deformity of Spine focused on measuring Growing rods, Scoliosis, Pediatric spine deformity

Eligibility Criteria

5 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

-Any patient with EOS who has been managed with GRs in our centre.

Exclusion Criteria:

  • Patients whose parents or guardians are not willing to participate in the study.

Sites / Locations

  • Assiut University Hospitals,department of Orthopaedics,Spine surgery unit.Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Children who had growing rods instrumentation for correction of Early Onset Scoliosis

Arm Description

Growing spine profiler instrumentation

Outcomes

Primary Outcome Measures

Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)
A score that measures the wider dimensions of outcomes involving the quality of life of patients and caregivers post-treatment.

Secondary Outcome Measures

Patient satisfaction (Likert scale)
A five point scale which is used to allow the individual to express how much they are satisified or unsatisified with the outcomes.
Trunk Height Gain (T1-S1 height).
The vertical distance from the midpoint of the superior endplate of T1 to the midpoint of the superior endplate of S1.
The degree of correction of the scoliosis and kyphosis.
measured through Cobb's angle
sagittal and coronal balance
measured through the C7 plumb line and the central sacral vertical line respectively.

Full Information

First Posted
June 22, 2021
Last Updated
June 29, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04945343
Brief Title
Long-Term Follow-Up Of Surgical Management Of Early Onset Scoliosis Using Growing Rods
Official Title
Long-Term Follow-Up Of Surgical Management Of Early Onset Scoliosis Using Growing Rods
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

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 aim of this work is to evaluate the long-term outcome of the graduates (those who completed the gradual lengthening procedures), to better understand the full scope and natural course of Growing Rods treatment for EOS and to have a glimpse of what happens to the graduates.
Detailed Description
The management of progressive early onset scoliosis (EOS) is challenging. The natural history can be severe deformity, restrictive lung disease, and early mortality . In the past, the standard of care for these children was early definitive spinal fusion and instrumentation. The belief was that a short and straight spine was superior to a long and deformed spine despite the negative effects of a short trunk. The principles of EOS treatment have changed with the appreciation that early fusion of the thoracic spine limits the growth of the spine and lungs, and eventually leads to respiratory failure and increased mortality. Furthermore, the cosmetic disfigurement from the disproportionate Trunk-Limb length is always not acceptable by the patients. The surgical treatment strategy for EOS has evolved significantly with the use of modern growth friendly implants, of these, Growing Rods(GR), first described by Moe and colleagues, attempt to allow the growth of the spine and thorax while controlling curve progression to preserve normal lung volume. Since then, several modifications and developments have been made and introduced worldwide. Evaluation of the mid to long-term follow up has seldom been reported in the literature. In Assiut university hospital the investigators operated a fair amount of children with EOS using growing rods starting 2009, with favourable short term results. The long-term outcome of the graduates (those who completed the gradual lengthening procedures), remains yet to be evaluated and reported. Research Methods and techniques: Type of the study: case series Study Setting: Assiut University Hospitals, Department of Orthopaedics, Spine Surgery Unit. Study subjects: Inclusion criteria: Any patient with EOS who has been managed with GRs in our centre. Exclusion criteria: Patients whose parents or guardians are not willing to participate in the study. Sample Size Calculation: All patients with EOS operated in our centre who have completed the GR procedures and became graduates since we started doing surgeries in 2009 to the present date. We expect to have complete data for 30 patients during the study period. -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ): Data sheet (Personal data, Cobb's angle, kyphosis angle, Shoulder balance, Coronal and sagittal balance, Pelvic obliquity, T1-S1 height,Span-Height ratio, patient satisfaction score (Likert scale). Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24) Arabic version . Radiological assessment (Cobb's angle, kyphosis angle, Shoulder balance, Coronal and sagittal balance, Pelvic obliquity, T1-S1 height, Implant Failure.) All data will be collected and recorded using the REDCap to facilitate data recording, analysis and creation of safe dedicated database. Research outcome measures: Primary (main): Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version) Secondary (subsidiary): 1-Patient satisfaction (Likert scale). 2 Trunk Height Gain (T1-S1 height). 3-Span-Height ratio. 4-The degree of correction of the scoliosis and kyphosis. 5-Maintenance of sagittal and coronal balance. Incidence of complications (PJK, DJK, recurrent infections, neurology, crankshaft phenomenon, etc)

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
Keywords
Growing rods, Scoliosis, Pediatric spine deformity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Use of growing Rods for correction of early onset scoliosis deformity of the spine
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children who had growing rods instrumentation for correction of Early Onset Scoliosis
Arm Type
Other
Arm Description
Growing spine profiler instrumentation
Intervention Type
Procedure
Intervention Name(s)
Growing Rods
Intervention Description
Growing Rods(GR), are implants used to correct pediatric scoliosis deformity. They attempt to allow the growth of the spine and thorax while controlling curve progression to preserve normal lung volume.
Primary Outcome Measure Information:
Title
Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)
Description
A score that measures the wider dimensions of outcomes involving the quality of life of patients and caregivers post-treatment.
Time Frame
Through study completion, an average of 2 years.
Secondary Outcome Measure Information:
Title
Patient satisfaction (Likert scale)
Description
A five point scale which is used to allow the individual to express how much they are satisified or unsatisified with the outcomes.
Time Frame
Through study completion, an average of 2 years.
Title
Trunk Height Gain (T1-S1 height).
Description
The vertical distance from the midpoint of the superior endplate of T1 to the midpoint of the superior endplate of S1.
Time Frame
Through study completion, an average of 2 years.
Title
The degree of correction of the scoliosis and kyphosis.
Description
measured through Cobb's angle
Time Frame
Through study completion, an average of 2 years.
Title
sagittal and coronal balance
Description
measured through the C7 plumb line and the central sacral vertical line respectively.
Time Frame
Through study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: -Any patient with EOS who has been managed with GRs in our centre. Exclusion Criteria: Patients whose parents or guardians are not willing to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Hatem, Master degree
Phone
+201027021317
Email
Amrhatemhassan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad El-Sharkawi, professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospitals,department of Orthopaedics,Spine surgery unit.
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad El-Sharkawi, Professor
Phone
+201005075855
Email
sharkoran@hotmail.com

12. IPD Sharing Statement

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Long-Term Follow-Up Of Surgical Management Of Early Onset Scoliosis Using Growing Rods

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