Curve Correction of Early Onset Scoliosis by Mehta Serial Casts

Scoliosis Clinical Trial

Official title:

Curve Correction of Early Onset Scoliosis by Mehta Serial Casts

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277089
• Other study ID #: Correction of EOS by casts
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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 .

Related Conditions & MeSH terms

• Scoliosis

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