Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies (OTP)

October 21, 2021 updated by: University Hospital, Strasbourg, France

Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

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
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
        • Contact:
          • Saïd CHAYER, PhD, HDR

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Major subjects with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies
Time Frame: Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]
Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

October 21, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 21, 2023

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7963

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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