Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies

Arthrodesis Clinical Trial

— OTP  

Official title:

Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100732
• Other study ID #: 7963
• Status: Recruiting
• Start date: October 21, 2020
• Est. completion date: March 21, 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: Yann Philippe CHARLES, MD, PhD
• Phone: 33 3 68 76 52 68
• Email: YannPhilippe.CHARLES[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 21, 2023
• Est. primary completion date: March 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrodesis

Locations

Country	Name	City	State
France	Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]