Description of the Organizational Measures Framing Surgery for Idiopathic Scoliosis in Children and Adolescents - Practice Survey

March 11, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
The pediatric orthopaedic surgeon treats idiopathic scoliosis in children and adolescents using the posterior vertebral arthrodesis technique. This surgery is considered "heavy" by the child and families while it is intended for a healthy population. Through this study to take stock of the measures governing idiopathic scoliosis surgery (pre-operative, intra-operative and post-operative) within the various pediatric orthopedic surgery departments on the French national territory.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal is to measure the interest of harmonizing the preparation of orthopedic surgery for idiopathic scoliosis in children and adolescents by implementing a ERAS (Enhanced Rehabilitation After Surgery) protocol nationwide.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the Société Française d'Orthopédie Pédiatrique (SoFOP) will be included.

Description

Inclusion Criteria:

  • Paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the Société Française d'Orthopédie Pédiatrique (SoFOP)

Exclusion Criteria:

  • Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
paediatric orthopaedic surgeons

paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the Société Française d'Orthopédie Pédiatrique (SoFOP) will be included.

questionnaire will be completed. .
Other: questionnaire on the organizational management
Data are collected through a questionnaire on the organizational management of the pre-operative / intraoperative / postoperative periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
practices currently in force for the preparation of posterior vertebral arthrodesis
Time Frame: Month: 3

Analysis practices currently in force for the preparation of posterior vertebral arthrodesis by intern results questionnaires.

questionnaire is created by the department specifically for this study
Month: 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Vincent Gautheron, MD PhD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Actual)

February 25, 2023

Study Completion (Actual)

February 25, 2023

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN1322022/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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