SPINAL Fracture, Spinal Stenosis, Vertebral Metastasis, Vertebral Osteomyelitis
Conditions
Keywords
spine, care, surgery, evolution
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.
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
Interventions
DIAGNOSTIC_TESTself-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)
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recourse to surgery | Inclusion visit | Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics | Inclusion visit, Visit Month 24 and Visit Month 36 | Weight of patient |
| Socio-demographic | Inclusion visit, Visit Month 24 and Visit Month 36 | Socio-demographic characteristics (occupation) |
| Questionnaire of Quality of life | Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits | 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 |
| Lower back pain. | Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits | 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. |
| Cervical pain | Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits | 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. |
| Cervical function, Upper limb function, Lower limb function, Bladder function, Quality of life. | Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits | 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). |
| Evaluation of the safety of care provided. | Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits | For each type of spinal pathology, measurement of: \- Incidence of serious medical complications |
Countries
France
Contacts
CONTACTBenjamin BOUYER, PROF
CONTACTOuidad BEN KACEM
PRINCIPAL_INVESTIGATORBenjamin BOUYER, PROF
University Hospital, Bordeaux
Outcome results
None listed