Clinical trial NCT03772119: Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
Official title: Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemivertebra
Keywords: Vertebral Malformation
Hemivertebra
Surgical resection
SOFOP
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children from 3 to 10 years old with vertebral malformation requiring surgery for hemivertebra

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Immediate effectiveness of surgery: Evolution of Cobb angle
timeFrame: From baseline to 6 months after surgery
measure: Appearances of complications
timeFrame: From baseline to 6 months after surgery
measure: Late persistence of complications
timeFrame: From 6 months after surgery to 15 years
Secondary outcomes:
measure: Long-term effectiveness of surgery: Evolution of Cobb angle
timeFrame: From 6 months after surgery to 15 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pediatric Surgery Service, University Hospital, Bordeaux
city: Grenoble
country: France
facility: Pediatric Surgery Service, University Hospital, Grenoble
city: Lyon
country: France
facility: Pediatric Surgery Service, University Hospital, Lyon
city: Marseille
country: France
facility: Pediatric Surgery Service, University Hospital, Marseille
city: Nantes
country: France
facility: Pediatric Surgery Service, University Hospital, Nantes
city: Nice
country: France
facility: Pediatric Surgery Service, University Hospital, Nice
city: Paris
country: France
facility: Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP
city: Paris
country: France
facility: Pediatric Surgery Service, Robert-Debré Hospital, AP-HP
city: Paris
country: France
facility: Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP
city: Rennes
country: France
facility: Pediatric Surgery Service, University Hospital, Rennes
city: Saint-Étienne
country: France
facility: Pediatric Surgery Service, University Hospital, Saint-Etienne
city: Toulouse
country: France
facility: Pediatric Surgery Service, University Hospital, Toulouse
city: Tours
country: France
facility: Pediatric Surgery Service, University Hospital, Tours
Study officials:
affiliation: University Hospttal, Tours
name: Thierry ODENT, MD-PhD
role: STUDY_DIRECTOR
References: