Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department

NCT07627282 | Recruiting

• 1 other identifier: CHUBX 2022/58
• Study Type: interventional
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal conditions are a major public health issue. Their management by surgical treatment is constantly improving and surgical procedures or implantable medical devices are experiencing significant progress. These innovations have not yet all been precisely evaluated but have already led to significant changes in care practices. The primary objective of our study is to describe, via an exhaustive collection of data, the quarterly evolution over 5 years of practices in the management of spinal pathologies.

Conditions

Spinal Stenosis; SPINAL Fracture; Vertebral Osteomyelitis; Vertebral Metastasis

Keywords

spine; care; surgery; evolution

Outcome Measures

Primary Outcomes (1)

• Recourse to surgery

  Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).

  Inclusion visit

Secondary Outcomes (15)

• Clinical characteristics

  Inclusion visit, Visit Month 24 and Visit Month 36

• Socio-demographic

  Inclusion visit, Visit Month 24 and Visit Month 36

• Socio-demographic

  Inclusion visit, Visit Month 24 and Visit Month 36

• Questionnaire of Quality of life

  Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits

• Questionnaire of Quality of life

  Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits

Study Arms (1)

Patient consulting in spine surgery

EXPERIMENTAL

quality of life scales for all patient consulting in spine surgery unit and psychological rating scales only for patients who require it (determined by the surgeon)

Diagnostic Test: self-administered questionnaire

Interventions

self-administered questionnaire DIAGNOSTIC_TEST

quality of life scales for all patient consulting in spine surgery unit and psychological rating scales only for patients who require it (determined by the surgeon)

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 \> 18 years old
• Minor patient, able to accept the data collection, with the consent of the holder(s)
• Patient consulting for a medical reason involving a spinal pathology in the investigating center (spinal surgery department): Degenerative pathology of the thoracic or lumbar spine; Degenerative pathology of the cervical spine; Deformation of the spine; Urgent traumatic, infectious and tumor pathologies.

You may not qualify if:

• Patient under guardianship or curators,
• Persons deprived of liberty by judicial or administrative decision,
• Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
• Persons unable to express their consent,
• Persons under legal protection,
• Patient not affiliated to a social protection scheme.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

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

Ouidad BEN KACEM

CONTACT

+335 56 79 87 18; ouidad.hasnaoui@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

Model Details: Exhaustive collection of data in a health data warehouse : collection of clinical, radiological examinations (standard of care), and self-administered questionnaire : quality of life scales for all patient consulting in spine surgery unit and psychological rating scales only for patients who require it (determined by the surgeon)

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: June 4, 2026
• Study Start: May 25, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

FR (1)