NCT03772119 Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
| NCT ID | NCT03772119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Hemivertebra |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-02-04 |
| Primary Completion | 2039-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2019-02-04 with a primary completion date of 2039-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Thierry ODENT, MD-PhD
STUDY DIRECTOR
University Hospttal, Tours
Frequently Asked Questions
Who can join the NCT03772119 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 10 Years, studying Hemivertebra. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03772119 currently recruiting?
Yes, NCT03772119 is actively recruiting participants. Contact the research team at T.ODENT@chu-tours.fr for enrollment information.
Where is the NCT03772119 trial being conducted?
This trial is being conducted at Bordeaux, France, Grenoble, France, Lyon, France, Marseille, France and 9 additional locations.
Who is sponsoring the NCT03772119 clinical trial?
NCT03772119 is sponsored by University Hospital, Tours. The principal investigator is Thierry ODENT, MD-PhD at University Hospttal, Tours. The trial plans to enroll 150 participants.