Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department (SPINDATA)

Evaluation of the Evolution of the Quality of Life of Patients Treated by the Spinal Pathology Department

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Stenosis; Vertebral Osteomyelitis; SPINAL Fracture; Vertebral Metastasis
• Intervention / Treatment: Diagnostic test: self-administered questionnaire

Detailed Description

The team will conduct a monocentric (department of spine surgery, University Hospital of Bordeaux, France) prospective observational study during 5 years, involving all patients treated for a spinal condition (including degenerative pathology of the lumbar, thoracic or cervical spine, deformities of the spine and for the traumatic, infectious and tumor pathologies).The data collected will concern the general condition of the patients, their reasons for consultation, the details of their spinal pathology and its impact using specific functional assessment self-questionnaires, as well as the care provided. A three years follow-up will be planned

• Study Type: Interventional
• Enrollment (Estimated): 15000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin BOUYER, PROF; Phone Number: +335 56 79 87 18; Email: b.bouyer@chu-bordeaux.fr
• Study Contact Backup: Name: Ouidad BEN KACEM; Phone Number: 14 367 +335 56 79 87 18; Email: ouidad.hasnaoui@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
    • Contact: Ouidad BEN KACEM; Phone Number: 14 367 +335 56 79 87 18; Email: ouidad.hasnaoui@chu-bordeaux.fr
    • Contact: Benjamin BOUYER, MD; Phone Number: +335 56 79 87 18; Email: b.bouyer@chu-bordeaux.fr
    • Principal Investigator: Benjamin BOUYER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient consulting in spine surgery; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics	Weight of patient	Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic	Socio-demographic characteristics (occupation)	Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic	Socio-demographic characteristics (sports activities)	Inclusion visit, Visit Month 24 and Visit Month 36
Questionnaire of Quality of life	Health-related quality of life evaluated using the SF-36 questionnaire. This questionnaire is composed of 11 items and total score from 0 to 100	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Questionnaire of Quality of life	Health-related quality of life evaluated using the EQ-5D-5L questionnaire. This questionnaire is composed of 5 items and total score from 5 to 25	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Lower back pain.	The ODI (Oswestry Disability Index) score is used to measure the degree of disability related to lower back pain. The questionnaire contains 10 items, each scored from 0 to 5 points. The maximum total score is 50 points.	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Cervical pain	The NDI is used to measure disability related to cervical pain via a standardized questionnaire. The questionnaire contains 10 items, each scored from 0 to 5 points. The maximum total score is 50 points. The higher the percentage, the greater the functional impairment.	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Cervical function, Upper limb function, Lower limb function, Bladder function, Quality of life.	The JOACMEQ (Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire) provides 5 independent scores (0-100): Cervical function, Upper limb function, Lower limb function, Bladder function, Quality of life. Each area gives a score between 0 (worst) and 100 (best condition).	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Evaluation of the safety of care provided.	For each type of spinal pathology, measurement of: - Incidence of serious medical complications	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Clinical characteristics	Body Mass Index of patient	Inclusion visit, Visit Month 24 and Visit Month 36
Evaluation of the safety of care provided.	For each type of spinal pathology, measurement of Incidence of mortality, assessed by recalling patients lost to follow-up	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Evaluation of the safety of care provided.	For each type of spinal pathology, measurement of Incidence of surgical site infections	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Evaluation of the safety of care provided.	For each type of spinal pathology, measurement of Incidence of mechanical complications	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Evaluation of the safety of care provided.	For each type of spinal pathology, measurement of Incidence of neurological complications	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Evaluation of the safety of care provided.	For each type of spinal pathology, measurement of Incidence of surgical re-interventions	Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Benjamin BOUYER, PROF, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: surgery; spine; care; evolution
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Spinal Diseases; Fractures, Bone; Back Injuries; Spinal Injuries; Spinal Stenosis; Spinal Fractures
• Other Study ID Numbers: CHUBX 2022/58

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No