Sagittal Balance Through Ages

Spinal Deformity Clinical Trial

— ESTA  

Official title:

Sagittal Balance Through Ages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467775
• Other study ID #: 7624
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: October 2, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: October 2, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Locations

Country	Name	City	State
France	Service de Chirurgie du Rachis	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 study of the radiographic parameters measured by the KEOPS software		files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined