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

NCT04945343 | Unknown DMC

• 1 other identifier: Results of growing rods
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-Onset Scoliosis Deformity of Spine

Keywords

Growing rods; Scoliosis; Pediatric spine deformity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient satisfaction (Likert scale)

  Through study completion, an average of 2 years.

• Trunk Height Gain (T1-S1 height).

  Through study completion, an average of 2 years.

• The degree of correction of the scoliosis and kyphosis.

  Through study completion, an average of 2 years.

• sagittal and coronal balance

  Through study completion, an average of 2 years.

Study Arms (1)

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

OTHER

Growing spine profiler instrumentation

Procedure: Growing Rods

Interventions

Growing Rods 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.

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

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

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

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mohammad El-Sharkawi, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Hatem, Master degree

CONTACT

+201027021317; Amrhatemhassan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Use of growing Rods for correction of early onset scoliosis deformity of the spine

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

EG (1)