- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467775
Sagittal Balance Through Ages (ESTA)
September 30, 2021 updated by: University Hospital, Strasbourg, France
The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary according to the types of spino-pelvic organization (types 1-4 according to Roussouly).
These parameters have been described as a function of age in previous scientific work without taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization).
This work, carried out within the framework of a round table of the French Society of Spinal Surgery (SFCR), would make it possible to provide a more detailed repository of existing radiographic parameters.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2000
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
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Strasbourg, France, 67091
- Service de Chirurgie du Rachis
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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
5 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation
Description
Inclusion criteria:
- Minor or major subject aged 5 to 100
- Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation
- Subject not having expressed its opposition, after information, to the re-use of its data for the purposes of this research.
Exclusion criteria:
- Subject with surgical history, fractures, osteoporotic packing, vertebral deformation (scoliosis, kyphosis, spondylolisthesis grades 2-5), vertebral osteolysis (spondylodiscitis, tumor or metastasis).
- Subject who expressed his opposition to participate in the study
- Subject under guardianship or curatorship
- Subject under judicial protection
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retrospective study of the radiographic parameters measured by the KEOPS software
Time Frame: files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined
|
files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 2, 2020
Primary Completion (Actual)
October 2, 2020
Study Completion (Actual)
October 2, 2020
Study Registration Dates
First Submitted
July 8, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 13, 2020
Study Record Updates
Last Update Posted (Actual)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 30, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7624
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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