Clinical trial NCT04527406: Early Surgical Intervention of Congenital Hemivertebra in Young Children
Official title: Early Hemivertebra Resection of Congenital Hemivertebra in Very Young Children: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Hemivertebra
Keywords: Congenital hemivertebra
Young Children
posterior hemivertebra resection
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of surgery
timeFrame: The operation time： from the beginning of the surgical skinning to the end of the surgical suture
Secondary outcomes:
measure: change of scoliosis cobb angle
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Children's hospital of fudan uviversity, shanghai, China
name: Dahui Wang, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.