Assessing the Socio-Psychological Determinants of Sagittal Balance (PSYPOS 2)

University Hospital of Bordeaux

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Patient consulting in spine surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07024121

CHUBX 2023/59

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Patient consulting in spine surgery

Experimental group

Description:

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) :

Treatment:

Diagnostic Test: Patient consulting in spine surgery