Clinical trial NCT07024121: Assessing the Socio-Psychological Determinants of Sagittal Balance
Official title: Assessing the Socio-Psychological Determinants of Sagittal Balance - PSYPOS2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Spine
Posture
Sagittal Balance
Socio-Psychological Factors
Keywords: Sagittal Balance
Socio-Psychological Factors
Postural Alignment
EOS Radiography
Orthopaedic Surgery
Healthy Spine
Spinal Function
Psychological Dimensions
Spinal Radiographs
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: * This study investigates 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.
* Posture, or sagittal balance, is a key aspect of spinal function. Considering sagittal balance is essential because its alteration leads to a decrease in quality of life and can quickly become a source of disability. Its analysis is conducted using defined parameters on spinal radiographs and is crucial for understanding spinal pathologies. Links between low back pain and posture have already been clearly reported, as well as between low back pain and socio-psychological factors. There is also evidence in the literature suggesting a relationship between socio-psychological factors and sagittal balance but these data are rare and fragmented, even though this association could be particularly pronounced in patients with spinal pathologies requiring surgical intervention.

However, it seems worthwhile to investigate this association between posture and socio-psychological characteristics in patients without spinal pathology to understand the link with other confounding or intermediate factors.

Furthermore, this association could be responsible for some of the variability in clinical and radiological outcomes of treatments, particularly surgical ones, with the presence of poor postoperative clinical outcomes despite adequate restoration of sagittal balance.

o This analytical, non-interventional study requires only one scheduled consultation within the care pathway of patients without spinal pathology consulting in the orthopaedic surgery department of the University Hospital of Bordeaux and undergoing EOS radiography as part of their care pathway. During this consultation, radiographic data and questionnaire responses will be collected.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between Global Tilt and socio-psychological variables
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between sagittal balance and BBQ questionnaire
timeFrame: Baseline
measure: Correlation between sagittal balance and SF-36
timeFrame: Baseline
measure: Relation between sagittal balance and demographic variables
timeFrame: Baseline
measure: Correlation between sagittal balance and TSK questionnaire
timeFrame: Baseline
measure: Correlation between sagittal balance and PCS questionnaire
timeFrame: Baseline
measure: Correlation between sagittal balance and HADS questionnaire
timeFrame: Baseline
measure: Correlation between sagittal balance and MSPQ questionnaire
timeFrame: Baseline
measure: Correlation between sagittal balance and Big Five Inventory questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Benjamin BOUYER, PROF
role: PRINCIPAL_INVESTIGATOR
References: