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Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children

R

Regional University Hospital Center (CHRU)

Status

Enrolling

Conditions

Hemivertebra

Treatments

Procedure: Surgical resection

Study type

Observational

Funder types

Other

Identifiers

NCT03772119
RIPH3-RNI17/HEMIVERTEBRE SOFOP

Details and patient eligibility

About

The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

Full description

The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

Enrollment

150 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Child from 3 to 10 years old
  • with a vertebral malformation requiring surgery for hemivertebras

Exclusion criteria

  • Child previously operated on the spine
  • Different procedure of a surgical resection of vertebral malformation
  • Absence of medical follow-up
  • Parents refusal concerning data storage

Trial design

150 participants in 1 patient group

Surgical treatment of hemivertebra
Description:
cohort of children with a vertebral malformation treated by surgical resection
Treatment:
Procedure: Surgical resection

Trial contacts and locations

13

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Central trial contact

Thierry ODENT, MD-PhD

Data sourced from clinicaltrials.gov

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