NCT03772119

Brief 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 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
153mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Feb 2019Feb 2039

First Submitted

Initial submission to the registry

November 22, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2039

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

20 years

First QC Date

November 22, 2018

Last Update Submit

April 29, 2026

Conditions

Hemivertebra

Keywords

Vertebral MalformationHemivertebraSurgical resectionSOFOP

Outcome Measures

Primary Outcomes (3)

  • Immediate effectiveness of surgery: Evolution of Cobb angle

    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

    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

    Persistent complications will be collected through clinical examination at follow-up visits.

    From 6 months after surgery to 15 years

Secondary Outcomes (1)

  • Long-term effectiveness of surgery: Evolution of Cobb angle

    From 6 months after surgery to 15 years

Study Arms (1)

Surgical treatment of hemivertebra

cohort of children with a vertebral malformation treated by surgical resection

Procedure: Surgical resection

Interventions

Surgical resectionPROCEDURE

Surgical resection of hemivertebra

Surgical treatment of hemivertebra

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Child from 3 to 10 years old
  • with a vertebral malformation requiring surgery for hemivertebras

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Pediatric Surgery Service, University Hospital, Bordeaux

Bordeaux, 33000, France

RECRUITING

Pediatric Surgery Service, University Hospital, Grenoble

Grenoble, 38043, France

NOT YET RECRUITING

Pediatric Surgery Service, University Hospital, Lyon

Lyon, 69677, France

NOT YET RECRUITING

Pediatric Surgery Service, University Hospital, Marseille

Marseille, 13005, France

RECRUITING

Pediatric Surgery Service, University Hospital, Nantes

Nantes, 44093, France

RECRUITING

Pediatric Surgery Service, University Hospital, Nice

Nice, 06200, France

RECRUITING

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

Paris, 75012, France

RECRUITING

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

Paris, 75019, France

RECRUITING

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

Paris, 75730, France

RECRUITING

Pediatric Surgery Service, University Hospital, Rennes

Rennes, 35203, France

RECRUITING

Pediatric Surgery Service, University Hospital, Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Pediatric Surgery Service, University Hospital, Toulouse

Toulouse, 31059, France

RECRUITING

Pediatric Surgery Service, University Hospital, Tours

Tours, 37044, France

RECRUITING

Study Officials

  • Thierry ODENT, MD-PhD

    University Hospttal, Tours

    STUDY DIRECTOR

Central Study Contacts

Thierry ODENT, MD-PhD

CONTACT

02 47 47 38 22T.ODENT@chu-tours.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

December 11, 2018

Study Start

February 4, 2019

Primary Completion (Estimated)

February 1, 2039

Study Completion (Estimated)

February 1, 2039

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)