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

NCT ID: NCT03772119

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-04

Study Completion Date

2039-02-28

Brief Summary

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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

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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

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Hemivertebra

Keywords

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Vertebral Malformation Hemivertebra Surgical resection SOFOP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical treatment of hemivertebra

cohort of children with a vertebral malformation treated by surgical resection

Surgical resection

Intervention Type PROCEDURE

Surgical resection of hemivertebra

Interventions

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Surgical resection

Surgical resection of hemivertebra

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry ODENT, MD-PhD

Role: STUDY_DIRECTOR

University Hospttal, Tours

Locations

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Pediatric Surgery Service, University Hospital, Bordeaux

Bordeaux, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Grenoble

Grenoble, , France

Site Status NOT_YET_RECRUITING

Pediatric Surgery Service, University Hospital, Lyon

Lyon, , France

Site Status NOT_YET_RECRUITING

Pediatric Surgery Service, University Hospital, Marseille

Marseille, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Nantes

Nantes, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Nice

Nice, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP

Paris, , France

Site Status RECRUITING

Pediatric Surgery Service, Robert-Debré Hospital, AP-HP

Paris, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP

Paris, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Rennes

Rennes, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Toulouse

Toulouse, , France

Site Status RECRUITING

Pediatric Surgery Service, University Hospital, Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thierry ODENT, MD-PhD

Role: CONTACT

Phone: 02 47 47 38 22

Email: [email protected]

Facility Contacts

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Yan LEFEVRE, MD-PhD

Role: primary

Aurélien COURVOISIER, MD-PhD

Role: primary

Thierry HAUMONT, MD-PhD

Role: primary

Vincent CUNIN, MD

Role: backup

Sébastien PESENTI, MD-PhD

Role: primary

Antoine HAMEL, MD-PhD

Role: primary

Federico SOLLA, MD

Role: primary

Raphael VIALLE, MD-PhD

Role: primary

Brice ILHARREBORDE, MD-PhD

Role: primary

Keyvan MAZDA, MD-PhD

Role: backup

Lofti MILADI, MD

Role: primary

Philippe VIOLAS, MD-PhD

Role: primary

Elie HADDAD, MD

Role: primary

Bruno DOHIN, MD-PhD

Role: backup

Franck ACCADBLED, MD-PhD

Role: primary

Thierry ODent, MD-PhD

Role: primary

Other Identifiers

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RIPH3-RNI17/HEMIVERTEBRE SOFOP

Identifier Type: -

Identifier Source: org_study_id