Early Surgical Intervention of Congenital Hemivertebra in Young Children

Not Applicable

Not yet recruiting

• Conditions: Congenital Hemivertebra

• Registration Number: NCT04527406
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Study Start: 2025-03-01
• Primary Completion: 2027-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of surgery	The operation time： from the beginning of the surgical skinning to the end of the surgical suture	The length of posterior hemivertebra resection operation time, acquired in the operation record from hospital

Secondary Outcome Measures

Name	Time	Method
change of scoliosis cobb angle	intraoperative	X-ray measurement of scoliosis cobb angle, by compare the preoperative and postoperative cobb angle changes to obtain the degree of scoliosis correction