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

April 29, 2026 updated by: University Hospital, Tours
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Bordeaux
        • Contact:
          • Yan LEFEVRE, MD-PhD
      • Grenoble, France, 38043
        • Not yet recruiting
        • Pediatric Surgery Service, University Hospital, Grenoble
        • Contact:
          • Aurélien COURVOISIER, MD-PhD
      • Lyon, France, 69677
        • Not yet recruiting
        • Pediatric Surgery Service, University Hospital, Lyon
        • Contact:
          • Thierry HAUMONT, MD-PhD
        • Contact:
          • Vincent CUNIN, MD
      • Marseille, France, 13005
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Marseille
        • Contact:
          • Sébastien PESENTI, MD-PhD
      • Nantes, France, 44093
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Nantes
        • Contact:
          • Antoine HAMEL, MD-PhD
      • Nice, France, 06200
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Nice
        • Contact:
          • Federico SOLLA, MD
      • Paris, France, 75012
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP
        • Contact:
          • Raphael VIALLE, MD-PhD
      • Paris, France, 75019
        • Recruiting
        • Pediatric Surgery Service, Robert-Debré Hospital, AP-HP
        • Contact:
          • Brice ILHARREBORDE, MD-PhD
        • Contact:
          • Keyvan MAZDA, MD-PhD
      • Paris, France, 75730
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP
        • Contact:
          • Lofti MILADI, MD
      • Rennes, France, 35203
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Rennes
        • Contact:
          • Philippe VIOLAS, MD-PhD
      • Saint-Etienne, France, 42055
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Saint-Etienne
        • Contact:
          • Elie HADDAD, MD
        • Contact:
          • Bruno DOHIN, MD-PhD
      • Toulouse, France, 31059
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Toulouse
        • Contact:
          • Franck ACCADBLED, MD-PhD
      • Tours, France, 37044
        • Recruiting
        • Pediatric Surgery Service, University Hospital, Tours
        • Contact:
          • Thierry ODent, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children from 3 to 10 years old with vertebral malformation requiring surgery for hemivertebra

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical treatment of hemivertebra
cohort of children with a vertebral malformation treated by surgical resection
Procedure: Surgical resection
Surgical resection of hemivertebra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to 6 months after surgery
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.
From baseline to 6 months after surgery
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.
From 6 months after surgery to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 6 months after surgery to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Thierry ODENT, MD-PhD, University Hospttal, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Estimated)

February 1, 2039

Study Completion (Estimated)

February 1, 2039

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RIPH3-RNI17/HEMIVERTEBRE SOFOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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