HemivertebraNCT03772119
Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
An observational study of Hemivertebra, run by University Hospital, Tours at 13 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Hemivertebra
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 13 sitesFrance
- Study dates
- 4 Feb 2019to Feb 2039
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: children from 3 to 10 years old with vertebral malformation requiring surgery for hemivertebra
Who may be able to join
- Child from 3 to 10 years old
- with a vertebral malformation requiring surgery for hemivertebras
Who cannot join
- 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 locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
Pediatric Surgery Service, University Hospital, Bordeaux
Bordeaux, 33000
Yan LEFEVRE, MD-PhD
- Not yet recruiting
Pediatric Surgery Service, University Hospital, Grenoble
Grenoble, 38043
Aurélien COURVOISIER, MD-PhD
- Not yet recruiting
Pediatric Surgery Service, University Hospital, Lyon
Lyon, 69677
Thierry HAUMONT, MD-PhD
Vincent CUNIN, MD
- Recruiting
Pediatric Surgery Service, University Hospital, Marseille
Marseille, 13005
Sébastien PESENTI, MD-PhD
- Recruiting
Pediatric Surgery Service, University Hospital, Nantes
Nantes, 44093
Antoine HAMEL, MD-PhD
- Recruiting
Pediatric Surgery Service, University Hospital, Nice
Nice, 06200
Federico SOLLA, MD
- Recruiting
Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP
Paris, 75012
Raphael VIALLE, MD-PhD
- Recruiting
Pediatric Surgery Service, Robert-Debré Hospital, AP-HP
Paris, 75019
Brice ILHARREBORDE, MD-PhD
Keyvan MAZDA, MD-PhD
- Recruiting
Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP
Paris, 75730
Lofti MILADI, MD
- Recruiting
Pediatric Surgery Service, University Hospital, Rennes
Rennes, 35203
Philippe VIOLAS, MD-PhD
- Recruiting
Pediatric Surgery Service, University Hospital, Saint-Etienne
Saint-Etienne, 42055
Elie HADDAD, MD
Bruno DOHIN, MD-PhD
- Recruiting
Pediatric Surgery Service, University Hospital, Toulouse
Toulouse, 31059
Franck ACCADBLED, MD-PhD
- Recruiting
Pediatric Surgery Service, University Hospital, Tours
Tours, 37044
Thierry ODent, MD-PhD
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).
Read the 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).
- Conditions
- Hemivertebra
- Being tested
- Surgical resection
- Keywords
- Vertebral Malformation, Hemivertebra, Surgical resection, SOFOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Surgical resection of hemivertebra
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment of hemivertebra | cohort of children with a vertebral malformation treated by surgical resection Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate effectiveness of surgery: Evolution of Cobb angle
Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile
Measured: From baseline to 6 months after surgery
Appearances of complications
Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.
Measured: From baseline to 6 months after surgery
Late persistence of complications
Persistent complications will be collected through clinical examination at follow-up visits.
Measured: From 6 months after surgery to 15 years
Secondary 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
Measured: From 6 months after surgery to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start4 Feb 2019
- Primary completionFeb 2039 (estimated)
- Study completionFeb 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemivertebraStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry ODENT, MD-PhD, Study director, University Hospttal, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772119
- Sponsor's protocol ID
- RIPH3-RNI17/HEMIVERTEBRE SOFOP
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2018
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
- ClinicalTrials.gov ID
- NCT03772119
- Acronym / sponsor ID
- RIPH3-RNI17/HEMIVERTEBRE SOFOP
- Conditions
- Hemivertebra
- Keywords
- Vertebral Malformation, Hemivertebra, Surgical resection, SOFOP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- Feb 2039 (estimated)
- Study completion
- Feb 2039 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment of hemivertebra | – | Procedure: Surgical resectioncohort of children with a vertebral malformation treated by surgical resection |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children from 3 to 10 years old with vertebral malformation requiring surgery for hemivertebra
Key inclusion criteria (2 listed)
- Child from 3 to 10 years old
- with a vertebral malformation requiring surgery for hemivertebras
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resectionSurgical resection of hemivertebra | Procedure or surgery | Surgical treatment of hemivertebra |
Primary outcome
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
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.
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.
1 secondary outcome
Long-term effectiveness of surgery: Evolution of Cobb angle
Time frame: From 6 months after surgery to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry ODENT, MD-PhD study director
University Hospttal, Tours
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemivertebra, run by University Hospital, Tours at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry ODENT, MD-PhD (02 47 47 38 22 ext. +33, T.ODENT@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate effectiveness of surgery: Evolution of Cobb angle (time frame: From baseline to 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.