Assessing the Socio-Psychological Determinants of Sagittal Balance

NCT ID: NCT07024121

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-06-30

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.

Conditions

Healthy Spine; Posture; Sagittal Balance; Socio-Psychological Factors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient consulting in spine surgery

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) :

Group Type: EXPERIMENTAL

Patient consulting in spine surgery

Intervention Type: DIAGNOSTIC_TEST

Self-administered questionnaire quality of life scales

Interventions

Patient consulting in spine surgery

Self-administered questionnaire quality of life scales

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin BOUYER, PROF

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Central Contacts

Benjamin BOUYER, PROF

Role: CONTACT

b.bouyer@chu-bordeaux.fr

+335 56 79 87 18

William GERBEAUX

Role: CONTACT

william.gerbeaux@chu-bordeaux.fr

Other Identifiers

CHUBX 2023/59

Identifier Type: -

Identifier Source: org_study_id