Early Surgical Intervention of Congenital Hemivertebra in Young Children

NCT04527406 | Withdrawn

• 1 other identifier: HEMI 1.1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Hemivertebra

Keywords

Congenital hemivertebra; Young Children; posterior hemivertebra resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change of scoliosis cobb angle

  intraoperative

Study Arms (2)

Early surgical group

EXPERIMENTAL

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

Traditional surgical treatment

ACTIVE COMPARATOR

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

Interventions

posterior hemivertebra resection PROCEDURE

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.

Early surgical group

conservative treatment+ delayed posterior hemivertebra resection PROCEDURE

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.

Traditional surgical treatment

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT.

You may not qualify if:

• Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Related Publications (1)

• Ginsburg G, Mulconrey DS, Browdy J. Transpedicular hemiepiphysiodesis and posterior instrumentation as a treatment for congenital scoliosis. J Pediatr Orthop. 2007 Jun;27(4):387-91. doi: 10.1097/01.bpb.0000271312.95621.b0.

  PMID: 17513957 BACKGROUND

Study Officials

• Dahui Wang, MD-PhD

  Children's hospital of fudan uviversity, shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor conduct independent statistical analysis and evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share