NCT06277089

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 26, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 13, 2024

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Correction of EOS by serial cast

OTHER
Other: Casts

Interventions

CastsOTHER

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

Correction of EOS by serial cast

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period .

You may not qualify if:

  • Cases with previous spine surgery and those whose guardians refuse to participate in the study .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26306805BACKGROUND
  • 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.

    PMID: 32757176BACKGROUND
  • 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.

    PMID: 32879567BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Mohammad Mostafa El Sharkawi

    Prof.dr

    STUDY DIRECTOR
  • Nariman Elsayed Mohammad ABOL Oyoun

    Prof.dr

    STUDY DIRECTOR

Central Study Contacts

Ahmed Kamal Zohery Darwish

CONTACT

Hesham Mohamed Elbaseet

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

January 13, 2024

First Posted

February 26, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

February 26, 2024

Record last verified: 2024-01