Practice ScopeNCT05843227
Description of the Organizational Measures Framing Surgery for Idiopathic Scoliosis in Children and Adolescents - Practice Survey
An observational study of Practice Scope, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Practice Scope
- What is being tested?
- questionnaire on the organizational management
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2023to 25 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Refusal
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Practice Scope
- Being tested
- questionnaire on the organizational management
- Keywords
- pediatric orthopaedic surgeon, Idiopathic Scoliosis, Pediatric, Enhanced Rehabilitation After Surgery (ERAS), posterior vertebral arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire on the organizational managementOther
Data are collected through a questionnaire on the organizational management of the pre-operative / intraoperative / postoperative periods.
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: Other: questionnaire on the organizational management |
What is being measured
The primary outcome is the main question the study is designed to answer.
practices currently in force for the preparation of posterior vertebral arthrodesis
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
Measured: Month: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start18 Jan 2023
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Practice ScopeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Gautheron, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843227
- Sponsor's protocol ID
- IRBN1322022/CHUSTE
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Organizational Measures Framing Surgery for Idiopathic Scoliosis in Children and Adolescents - Practice Survey
- ClinicalTrials.gov ID
- NCT05843227
- Acronym / sponsor ID
- IRBN1322022/CHUSTE
- Conditions
- Practice Scope
- Keywords
- pediatric orthopaedic surgeon, Idiopathic Scoliosis, Pediatric, Enhanced Rehabilitation After Surgery (ERAS), posterior vertebral arthrodesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paediatric orthopaedic surgeons | – | Other: questionnaire on the organizational managementpaediatric 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. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire on the organizational managementData are collected through a questionnaire on the organizational management of the pre-operative / intraoperative / postoperative periods. | Other | paediatric orthopaedic surgeons |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gautheron, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Practice Scope, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
practices currently in force for the preparation of posterior vertebral arthrodesis (time frame: Month: 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.