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Early Surgical Intervention of Congenital Hemivertebra in Young Children

NCT04527406 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-03-27

No results posted yet for this study

Summary

Early treatment of congenital hemivertebrae is very important. The investigators design this study to figure out how early hemivertebrae resection be apply to children. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into early operation group and control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and then will undergo operation after 5 years old. Primary Outcome Measure is the length of spine surgery.

Conditions

  • Congenital Hemivertebra

Interventions

PROCEDURE

posterior hemivertebra resection

The subjects in early surgical group are arranged to be admitted to for surgical treatment very soon. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good.

PROCEDURE

conservative treatment+ delayed posterior hemivertebra resection

In traditional surgical group, subjects received conservative treatment firstly with custom-made braces to delay the progression of scoliosis. It is planned to use the classic posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction to complete the correction around the age of 5. The operation choice is identical with early surgical group. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Dahui Wang, MD-PhD · Children's hospital of fudan uviversity, shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-12-30
Completion
2028-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527406 on ClinicalTrials.gov