Early Surgical Intervention of Congenital Hemivertebra in Young Children

Study Overview
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Brief Summary
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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.

Detailed Description
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Early diagnosis and early effective treatment of congenital hemivertebrae can correct the deformities.Therefore, traditionally, children with a clear diagnosis should be fixed with a brace to delay the aggravation of scoliosis and then undergo surgery after 5 years of age. The design of this study is to conduct a single-center randomized controlled study. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into the early operation group and the 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 posterior scoliosis correction will be performed after the age was over 5 years old. The primary outcome measures are the length of spine surgery for the two groups of children. The secondary outcome measures are change of scoliosis cobb angle, by comparing preoperative and postoperative cobb angle changes. It is expected that the early treatment group will shorten the length of surgery due to the smaller degree of scoliosis. Our research is expected to broaden the age-adaptation of classic spinal surgery in the field of pediatric spine.

Official Title
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Early Hemivertebra Resection of Congenital Hemivertebra in Very Young Children: A Randomized Clinical Study

Conditions
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Congenital Hemivertebra

Intervention / Treatment
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* Procedure: posterior hemivertebra resection
* Procedure: conservative treatment+ delayed posterior hemivertebra resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT. Exclusion Criteria: Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The research subjects are randomly assigned to the early surgery group (experimental group) or traditional surgery group (control group) at a ratio of 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early surgical group<br>The subjects in this group received early surgical treatment, and they are arranged to be admitted to the hospital for surgical treatment after admission. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. | Procedure: posterior hemivertebra resection<br>* 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.<br>|
| Active Comparator: Traditional surgical treatment<br>This group of subjects received conservative treatment 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. | Procedure: conservative treatment+ delayed posterior hemivertebra resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | The length of posterior hemivertebra resection operation time, acquired in the operation record from hospital | The operation time： from the beginning of the surgical skinning to the end of the surgical suture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of scoliosis cobb angle | X-ray measurement of scoliosis cobb angle, by compare the preoperative and postoperative cobb angle changes to obtain the degree of scoliosis correction | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital hemivertebra, Young Children, posterior hemivertebra resection