ScoliosisNCT06277089
Curve Correction of Early Onset Scoliosis by Mehta Serial Casts
A study testing Casts in people with Scoliosis, run by Assiut University.
Trial summary
Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Casts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Sep 2025
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period .
Who cannot join
- Cases with previous spine surgery and those whose guardians refuse to participate in the study .
Trial locations and contacts
No sites are listed yet.
Hesham Mohamed Elbaseet contact
About this study
Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis
Read the detailed description
Early Onset Scoliosis refers to various types of Scoliosis with onset before 10 years of age .In addition to spinal Deformity Progressive Scoliosis will also affect the development of thoracic cage and lungs . So Early correction is important .
Curve correction can done by operative and nonoperative techniques . Our Study include the curve correction by Mehta Serial Casts which not need for blood transfusion and has a good role in stop progression and delay the need for surgery .
- Conditions
- Scoliosis
- Being tested
- Casts
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CastsOther
According to level of scoliosis cast done and recast in a serial manner
| Study group | Role | What they receive |
|---|---|---|
| Correction of EOS by serial cast | Other | Not described Receives: Other: Casts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the scoliotic cobb angle at last cast
Measurement of Cobb angle in every visit and find the difference of the Scoliotic Cobb angle between first and last visit to assist the Correction ( Cobb angle measured by X Ray
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies 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
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kamal Zohery, Assiut University
- Investigators
- Mohammad Mostafa El Sharkawi, Study director, Prof.drNariman Elsayed Mohammad ABOL Oyoun, Study director, Prof.dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277089
- Sponsor's protocol ID
- Correction of EOS by casts
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thorsness RJ, Faust JR, Behrend CJ, Sanders JO. Nonsurgical Management of Early-onset Scoliosis. J Am Acad Orthop Surg. 2015 Sep;23(9):519-28. doi: 10.5435/JAAOS-D-14-00019.
PubMed 26306805Matsumoto H, Auran E, Fields MW, Hung CW, Hilaire TS, Roye B, Sturm P, Garg S, Sanders J, Oetgen M, Levine S, Roye D, Vitale M; Pediatric Spine Study Group. Serial casting for early onset scoliosis and its effects on health-related quality of life during and after discontinuation of treatment. Spine Deform. 2020 Dec;8(6):1361-1367. doi: 10.1007/s43390-020-00175-5. Epub 2020 Aug 5.
PubMed 32757176Mahajan R, Kishan S, Mallepally AR, Shafer C, Marathe N, Chhabra HS. Evolution of casting techniques in early-onset and congenital scoliosis. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):810-815. doi: 10.1016/j.jcot.2020.06.034. Epub 2020 Jul 8.
PubMed 32879567
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curve Correction of Early Onset Scoliosis by Mehta Serial Casts
- ClinicalTrials.gov ID
- NCT06277089
- Acronym / sponsor ID
- Correction of EOS by casts
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 26 Feb 2024 (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.
Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis
Detailed description
Early Onset Scoliosis refers to various types of Scoliosis with onset before 10 years of age .In addition to spinal Deformity Progressive Scoliosis will also affect the development of thoracic cage and lungs . So Early correction is important .
Curve correction can done by operative and nonoperative techniques . Our Study include the curve correction by Mehta Serial Casts which not need for blood transfusion and has a good role in stop progression and delay the need for surgery .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correction of EOS by serial cast | Other | Other: Casts |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period .
Key exclusion criteria (1 listed)
- Cases with previous spine surgery and those whose guardians refuse 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 |
|---|---|---|
| CastsAccording to level of scoliosis cast done and recast in a serial manner | Other | Correction of EOS by serial cast |
Primary outcome
Difference of the scoliotic cobb angle at last cast
Time frame: 1 year
Measurement of Cobb angle in every visit and find the difference of the Scoliotic Cobb angle between first and last visit to assist the Correction ( Cobb angle measured by X Ray
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 26306805Thorsness RJ, Faust JR, Behrend CJ, Sanders JO. Nonsurgical Management of Early-onset Scoliosis. J Am Acad Orthop Surg. 2015 Sep;23(9):519-28. doi: 10.5435/JAAOS-D-14-00019.
- Background: PubMed 32757176Matsumoto H, Auran E, Fields MW, Hung CW, Hilaire TS, Roye B, Sturm P, Garg S, Sanders J, Oetgen M, Levine S, Roye D, Vitale M; Pediatric Spine Study Group. Serial casting for early onset scoliosis and its effects on health-related quality of life during and after discontinuation of treatment. Spine Deform. 2020 Dec;8(6):1361-1367. doi: 10.1007/s43390-020-00175-5. Epub 2020 Aug 5.
- Background: PubMed 32879567Mahajan R, Kishan S, Mallepally AR, Shafer C, Marathe N, Chhabra HS. Evolution of casting techniques in early-onset and congenital scoliosis. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):810-815. doi: 10.1016/j.jcot.2020.06.034. Epub 2020 Jul 8.
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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.
Hesham Mohamed Elbaseet contact
Mohammad Mostafa El Sharkawi study director
Prof.dr
Nariman Elsayed Mohammad ABOL Oyoun study director
Prof.dr
Questions about this trial
What is this clinical trial studying?
A study testing Casts in people with Scoliosis, run by Assiut University.
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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Kamal Zohery Darwish (01023060980, ak290373@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the scoliotic cobb angle at last cast (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277089, which also lists 3 linked publications.
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 26 Feb 2024.