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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06277089
Other study ID # Correction of EOS by casts
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date September 1, 2025

Study information

Verified date January 2024
Source Assiut University
Contact Ahmed Kamal Zohery Darwish
Phone 01023060980
Email ak290373@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 5
Est. completion date September 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria: - All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period . Exclusion Criteria: - Cases with previous spine surgery and those whose guardians refuse to participate in the study .

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Casts
According to level of scoliosis cast done and recast in a serial manner

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Mahajan 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. — View Citation

Matsumoto 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
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