Surgical resection
ProcedureSurgical resection of hemivertebra
Recruiting
NCT Number: NCT03772119
Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
3 year–10 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Pediatric Surgery Service, University Hospital, Bordeaux, Bordeaux, France
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About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Immediate effectiveness of surgery: Evolution of Cobb angle
Time frame: From baseline to 6 months after surgery
Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile
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Appearances of complications
Time frame: From baseline to 6 months after surgery
Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.
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Late persistence of complications
Time frame: From 6 months after surgery to 15 years
Persistent complications will be collected through clinical examination at follow-up visits.
Secondary outcomes
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Long-term effectiveness of surgery: Evolution of Cobb angle
Time frame: From 6 months after surgery to 15 years
Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Tours
Other
Registry information
Important dates
- Study start
- 2019
- Primary completion
- 2039
- Study completion
- 2039
- First posted
- Dec 11, 2018
- Registry last updated
- Apr 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.