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

Early-Onset Scoliosis Deformity of Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945343
• Other study ID #: Results of growing rods
• Status: Recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: June 2023

Study information

• Verified date: June 2021
• Source: Assiut University
• Contact: Amr Hatem, Master degree
• Phone: +201027021317
• Email: Amrhatemhassan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Inclusion criteria:

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

2. Exclusion criteria:

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

3. 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:

1. Primary (main):

Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)

2. 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Early-Onset Scoliosis Deformity of Spine
• Scoliosis

Intervention

Procedure:
• Growing Rods
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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals,department of Orthopaedics,Spine surgery unit.	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 2 years.
Secondary	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.	Through study completion, an average of 2 years.
Secondary	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.	Through study completion, an average of 2 years.
Secondary	The degree of correction of the scoliosis and kyphosis.	measured through Cobb's angle	Through study completion, an average of 2 years.
Secondary	sagittal and coronal balance	measured through the C7 plumb line and the central sacral vertical line respectively.	Through study completion, an average of 2 years.