Assessing the Socio-Psychological Determinants of Sagittal Balance (NCT07024121) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessing the Socio-Psychological Determinants of Sagittal Balance
150 participantsStarted 2025-12
Plain-language summary
The research focuses on describing the association between socio-psychological factors, collected through standardized self-questionnaires, and the postural alignment of patients without spinal pathology consulting in the orthopaedic surgery department, as evaluated on EOS® radiographic images. This mono-centric, analytical, non-interventional, cross-sectional epidemiological study has for primary outcome to explore the relationship between socio-psychological factors and posture in patients with a healthy spine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient aged ≥ 18 years
* Patient consulting at the investigational center (orthopaedic surgery department of Bordeaux University Hospital) who has undergone or will undergo an EOS® radiography as part of their treatment pathway (particularly in the context of a preoperative assessment for hip arthroplasty).
* Affiliation with a medical insurance scheme under the French National Health Insurance.
Exclusion Criteria:
* Spinal fusion at any operated level,
* Active or non-active spinal infection at any level,
* Spinal fracture at any level,
* Spinal deformity:
* Scheuermann's disease (at least 3 adjacent vertebrae with wedge deformity and kyphosis increased by 5 degrees),
* Scoliosis (Cobb angle \> 10 degrees and vertebral rotation).
* History of Parkinson's disease
* Active cancer or hematologic disorder with bone involvement
* Any condition preventing the ability to respond to questionnaires with discernment
* Neurological deficit requiring urgent surgical intervention
* Hyperalgesic condition requiring urgent surgical intervention
* Polytrauma with organ failure
* Patient unable to understand study-related information
* Patient under guardianship or curatorship,
* Persons deprived of liberty by judicial or administrative decision,
* Persons receiving psychiatric care under constraint,
* Persons under guardianship,
* Patient not affiliated with a social protection scheme
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between Global Tilt and socio-psychological variables