Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

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

NCT03772119 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-02-04
Last updated
2026-04-30

Condition(s) studied

Hemivertebra

Investigational drug(s) / intervention(s)

Surgical resection

Surgical resection: Surgical resection of hemivertebra

Study 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).

Eligibility

Sex
ALL
Min age
3 Years
Max age
10 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Immediate effectiveness of surgery: Evolution of Cobb angle — 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 — 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 — From 6 months after surgery to 15 years
    Persistent complications will be collected through clinical examination at follow-up visits.

Trial sites (13)

FacilityCityRegionStatus
Pediatric Surgery Service, University Hospital, Bordeaux Bordeaux France Recruiting
Pediatric Surgery Service, University Hospital, Grenoble Grenoble France Not Yet Recruiting
Pediatric Surgery Service, University Hospital, Lyon Lyon France Not Yet Recruiting
Pediatric Surgery Service, University Hospital, Marseille Marseille France Recruiting
Pediatric Surgery Service, University Hospital, Nantes Nantes France Recruiting
Pediatric Surgery Service, University Hospital, Nice Nice France Recruiting
Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP Paris France Recruiting
Pediatric Surgery Service, Robert-Debré Hospital, AP-HP Paris France Recruiting
Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP Paris France Recruiting
Pediatric Surgery Service, University Hospital, Rennes Rennes France Recruiting
Pediatric Surgery Service, University Hospital, Saint-Etienne Saint-Etienne France Recruiting
Pediatric Surgery Service, University Hospital, Toulouse Toulouse France Recruiting
Pediatric Surgery Service, University Hospital, Tours Tours France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03772119 on ClinicalTrials.gov ↗ ← All trials in France