Clinical trial NCT04945343: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Early-Onset Scoliosis Deformity of Spine
Keywords: Growing rods
Scoliosis
Pediatric spine deformity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Use of growing Rods for correction of early onset scoliosis deformity of the spine
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Patient satisfaction (Likert scale)
timeFrame: Through study completion, an average of 2 years.
measure: Trunk Height Gain (T1-S1 height).
timeFrame: Through study completion, an average of 2 years.
measure: The degree of correction of the scoliosis and kyphosis.
timeFrame: Through study completion, an average of 2 years.
measure: sagittal and coronal balance
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals,department of Orthopaedics,Spine surgery unit.
Study officials:
affiliation: Assiut University
name: Mohammad El-Sharkawi, professor
role: PRINCIPAL_INVESTIGATOR
References: