Spinal DeformityESTANCT04467775
Sagittal Balance Through Ages
An observational study of Spinal Deformity, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 5 to 100 years
- Conditions the study is for
- Spinal Deformity
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2020to 2 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Deformity
- Keywords
- Spinal Deformity, Low back pain, Sciatica, Cervico brachial neuralgia
- Medical subject headings
- Low Back Pain, Sciatica, Brachial Plexus Neuritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the radiographic parameters measured by the KEOPS software
Measured: files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start2 Jan 2020
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467775
- Sponsor's protocol ID
- 7624
- Acronym
- ESTA
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charles YP, Prost S, Pesenti S, Ilharreborde B, Bauduin E, Laouissat F, Riouallon G, Wolff S, Challier V, Obeid I, Boissiere L, Ferrero E, Solla F, Le Huec JC, Bourret S, Faddoul J, Abi Lahoud GN, Fiere V, Vande Kerckhove M, Campana M, Lebhar J, Giorgi H, Faure A, Sauleau EA, Blondel B; French Spine Surgery Society (SFCR). Variation of cervical sagittal alignment parameters according to gender, pelvic incidence and age. Eur Spine J. 2022 May;31(5):1228-1240. doi: 10.1007/s00586-021-07102-w. Epub 2022 Jan 6.
PubMed 34989876
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal Balance Through Ages
- ClinicalTrials.gov ID
- NCT04467775
- Acronym / sponsor ID
- ESTA / 7624
- Conditions
- Spinal Deformity
- Keywords
- Spinal Deformity, Low back pain, Sciatica, Cervico brachial neuralgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 34989876Charles YP, Prost S, Pesenti S, Ilharreborde B, Bauduin E, Laouissat F, Riouallon G, Wolff S, Challier V, Obeid I, Boissiere L, Ferrero E, Solla F, Le Huec JC, Bourret S, Faddoul J, Abi Lahoud GN, Fiere V, Vande Kerckhove M, Campana M, Lebhar J, Giorgi H, Faure A, Sauleau EA, Blondel B; French Spine Surgery Society (SFCR). Variation of cervical sagittal alignment parameters according to gender, pelvic incidence and age. Eur Spine J. 2022 May;31(5):1228-1240. doi: 10.1007/s00586-021-07102-w. Epub 2022 Jan 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Deformity, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.