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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals,department of Orthopaedics,Spine surgery unit.
Asyut, 71111
Mohammad El-Sharkawi, Professor, +201005075855, sharkoran@hotmail.com
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:
- 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.
- 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:
- Primary (main): Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Children who had growing rods instrumentation for correction of Early Onset Scoliosis | Other | Growing spine profiler instrumentation Receives: Procedure: Growing Rods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
The degree of correction of the scoliosis and kyphosis.
measured through Cobb's angle
Measured: Through study completion, an average of 2 years.
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.
- First posted30 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Onset Scoliosis Deformity of SpineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hatem Ahmed Mohammed, Assiut University
- Investigators
- Mohammad El-Sharkawi, professor, Principal investigator, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Of Surgical Management Of Early Onset Scoliosis Using Growing Rods
- ClinicalTrials.gov ID
- NCT04945343
- Acronym / sponsor ID
- Results of growing rods
- Conditions
- Early-Onset Scoliosis Deformity of Spine
- Keywords
- Growing rods, Scoliosis, Pediatric spine deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Primary (main): Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of growing Rods for correction of early onset scoliosis deformity of the spine
| Arm | Type | Receives |
|---|---|---|
| Children who had growing rods instrumentation for correction of Early Onset Scoliosis | Other | Procedure: Growing RodsGrowing spine profiler instrumentation |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Any patient with EOS who has been managed with GRs in our centre.
Key exclusion criteria (1 listed)
- Patients whose parents or guardians are not willing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growing RodsGrowing 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. | Procedure or surgery | Children who had growing rods instrumentation for correction of Early Onset Scoliosis |
Primary outcome
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.
A score that measures the wider dimensions of outcomes involving the quality of life of patients and caregivers post-treatment.
4 secondary outcomes
Patient satisfaction (Likert scale)
Time frame: Through study completion, an average of 2 years.
Trunk Height Gain (T1-S1 height).
Time frame: Through study completion, an average of 2 years.
The degree of correction of the scoliosis and kyphosis.
Time frame: Through study completion, an average of 2 years.
sagittal and coronal balance
Time frame: Through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad El-Sharkawi, professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
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.