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

NCT ID: NCT04945343

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-06-30

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:

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)

Conditions

Early-Onset Scoliosis Deformity of Spine

Keywords

Growing rods; Scoliosis; Pediatric spine deformity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Growing spine profiler instrumentation

Group Type: OTHER

Growing Rods

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amr Hatem Ahmed Mohammed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad El-Sharkawi, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amr Hatem, Master degree

Role: CONTACT

Phone: +201027021317

Email: Amrhatemhassan@gmail.com

Facility Contacts

Mohammad El-Sharkawi, Professor

Role: primary

Other Identifiers

Results of growing rods

Identifier Type: -

Identifier Source: org_study_id