NCT05100732

Brief Summary

Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life. In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated. Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term. the aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques

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 21, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

October 21, 2021

Last Update Submit

October 21, 2021

Conditions

Keywords

Arthrodesisdegenerative lumbar scoliosisScoliosisspinal dysmorphism

Outcome Measures

Primary Outcomes (1)

  • Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies

    Files analysed retrospectively from January 01, 2010 to December 31, 2010 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 anterior imbalance by transpedicular osteotomy

You may qualify if:

  • Major subjects\> 18 years old
  • Subject operated at HUS between 01/01/2010 to 31/12/2020
  • Subject with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy
  • 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

MeSH Terms

Conditions

AnkylosisScoliosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesSpinal CurvaturesSpinal DiseasesBone Diseases

Central Study Contacts

Yann Philippe CHARLES, MD, PhD

CONTACT

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 29, 2021

Study Start

October 21, 2020

Primary Completion

March 1, 2023

Study Completion

March 21, 2023

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations