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Early-Onset Scoliosis Deformity of SpineNCT04945343

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

A study testing Growing Rods in people with Early-Onset Scoliosis Deformity of Spine, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 20 years
Conditions the study is for
Early-Onset Scoliosis Deformity of Spine
What is being tested?
Growing Rods
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
Jun 2021to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Amr Hatem, Master degree contact

+201027021317

Amrhatemhassan@gmail.com

Egypt1 site, 1 recruiting
  • Assiut University Hospitals,department of Orthopaedics,Spine surgery unit.

    Asyut, 71111

    Mohammad El-Sharkawi, Professor, +201005075855, sharkoran@hotmail.com

    Recruiting

Other trials in Egypt

About this study

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.

Read the 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)
Being tested
Growing Rods
Keywords
Growing rods, Scoliosis, Pediatric spine deformity
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Growing RodsProcedure or surgery

    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.

Study groups in NCT04945343
Study groupRoleWhat they receive
Children who had growing rods instrumentation for correction of Early Onset ScoliosisOtherGrowing spine profiler instrumentation
Receives: Procedure: Growing Rods

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, an average of 2 years.

Secondary outcomes (4)
  1. 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.

    Measured: Through study completion, an average of 2 years.

  2. 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.

    Measured: Through study completion, an average of 2 years.

  3. The degree of correction of the scoliosis and kyphosis.

    measured through Cobb's angle

    Measured: Through study completion, an average of 2 years.

  4. sagittal and coronal balance

    measured through the C7 plumb line and the central sacral vertical line respectively.

    Measured: Through study completion, an average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Use of growing Rods for correction of early onset scoliosis deformity of the spine
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945343
Sponsor's protocol ID
Results of growing rods
Status last verified
Jun 2021
First submitted
22 Jun 2021
Last updated
30 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Growing Rods in people with Early-Onset Scoliosis Deformity of Spine, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amr Hatem, Master degree (+201027021317, Amrhatemhassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version) (time frame: Through study completion, an average of 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.

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