Assessing the Socio-Psychological Determinants of Sagittal Balance

NCT07024121 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/59
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Correlation between Global Tilt and socio-psychological variables

  The relationship between sagittal balance, assessed using EOS® imaging and measured by the angle known as Global Tilt (GT), and socio-psychological variables . Sagittal balance is normal if the Global Tilt angle is less than 23.2 degrees. When the Global Tilt angle is more than 33.7 degrees, it is considered that there is a moderate pathological imbalance of the sagittal balance

  Baseline

Secondary Outcomes (8)

• Correlation between sagittal balance and BBQ questionnaire

  Baseline

• Correlation between sagittal balance and SF-36

  Baseline

• Relation between sagittal balance and demographic variables

  Baseline

• Correlation between sagittal balance and TSK questionnaire

  Baseline

• Correlation between sagittal balance and PCS questionnaire

  Baseline

Study Arms (1)

Patient consulting in spine surgery

EXPERIMENTAL

Patient consulting in spine surgery who have undergone or will undergo an EOS X-ray as part of their care pathway (particularly as part of a pre-operative assessment for hip arthroplasty) :

Diagnostic Test: Patient consulting in spine surgery

Interventions

Patient consulting in spine surgery DIAGNOSTIC_TEST

Self-administered questionnaire quality of life scales

Patient consulting in spine surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Officials

• Benjamin BOUYER, PROF

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin BOUYER, PROF

CONTACT

+335 56 79 87 18; b.bouyer@chu-bordeaux.fr

William GERBEAUX

CONTACT

william.gerbeaux@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: June 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12