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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03772119
Enrollment
150
Registered
2018-12-11
Start date
2019-02-04
Completion date
2039-02-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemivertebra

Keywords

Vertebral Malformation, Hemivertebra, Surgical resection, SOFOP

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).

Interventions

PROCEDURESurgical resection

Surgical resection of hemivertebra

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Immediate effectiveness of surgery: Evolution of Cobb angleFrom baseline to 6 months after surgeryEffectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile
Appearances of complicationsFrom baseline to 6 months after surgeryAppearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.
Late persistence of complicationsFrom 6 months after surgery to 15 yearsPersistent complications will be collected through clinical examination at follow-up visits.

Secondary

MeasureTime frameDescription
Long-term effectiveness of surgery: Evolution of Cobb angleFrom 6 months after surgery to 15 yearsMaintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile

Countries

France

Contacts

CONTACTThierry ODENT, MD-PhD
T.ODENT@chu-tours.fr02 47 47 38 22
STUDY_DIRECTORThierry ODENT, MD-PhD

University Hospttal, Tours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026