NCT05128279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2023

Completed
Last Updated

November 30, 2021

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

October 20, 2021

Last Update Submit

November 23, 2021

Conditions

Idiopathic Scoliosis

Keywords

Idiopathic scoliosisThoracic hyperkyphosisCyphosis

Outcome Measures

Primary Outcomes (1)

  • 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]

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Yann Philippe CHARLES, MD, PhD

CONTACT

33 3 68 76 52 68YannPhilippe.CHARLES@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 19, 2021

Study Start

October 28, 2020

Primary Completion

March 1, 2023

Study Completion

March 18, 2023

Last Updated

November 30, 2021

Record last verified: 2021-10

Locations

FR(1)