Adolescent and Young Adulte Scoliosis | NCT05128279

Studies
Adolescent and Young Adulte Scoliosis

NCT05128279

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Nov 30, 2021Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Idiopathic Scoliosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2020Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 18, 2023Estimated

First Submitted Date

Oct 20, 2021

First Submission Date that Met QC Criteria

Nov 17, 2021

First Posted Date

Nov 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2021

Last Update Posted Date

Nov 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis.

The objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of corrections of adolescent and young adult scoliosis by posterior instrumentation		Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Major subjects> 18 years old
Subject with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis
Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

Subject having expressed opposition to participating in the study
Subject under guardianship or guardianship
Subject under safeguard of justice

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subjects with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yann Philippe CHARLES, MD, PhD	Contact	33 3 68 76 52 68		YannPhilippe.CHARLES@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg	Recruiting	Strasbourg		67091	France