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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05105737
Other study ID # 7962
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 29, 2020
Est. completion date March 29, 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
Health authority
Study type Observational

Clinical Trial Summary

Several deformities of the spine exist such as degenerative lumbar scoliosis. 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 the analysis of surgical corrections obtained 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 29, 2023
Est. primary completion date March 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Major subjects> 18 years old - Subject with a surgical indication for arthrodesis and surgical correction of degenerative 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

Study Design


Related Conditions & MeSH terms


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 degenerative scoliosis corrections by posterior instrumentation Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]
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