Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
ConditionHemivertebra
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-10
SponsorUniversity Hospital, Tours
About this trial
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
This trial does not accept healthy volunteersQualifiers
Child from 3 to 10 years old
with a vertebral malformation requiring surgery for hemivertebras
Disqualifiers
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 population
children from 3 to 10 years old with vertebral malformation requiring surgery for hemivertebra
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical resection
Procedure/SurgerySurgical resection of hemivertebra
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Surgical treatment of hemivertebra1 intervention
Trial outcomes
Primary outcomes
1
Immediate effectiveness of surgery: Evolution of Cobb angle
Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile
Time frame
From baseline to 6 months after surgery2
Appearances of complications
Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.
Time frame
From baseline to 6 months after surgery3
Late persistence of complications
Persistent complications will be collected through clinical examination at follow-up visits.
Time frame
From 6 months after surgery to 15 yearsSecondary outcomes
1
Long-term effectiveness of surgery: Evolution of Cobb angle
Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile
Time frame
From 6 months after surgery to 15 yearsSponsors and contacts
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Source ClinicalTrials.gov