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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical characteristics | Weight of patient | Inclusion visit, Visit Month 24 and Visit Month 36 |
| Socio-demographic | Socio-demographic characteristics (occupation) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin BOUYER, PROF | Contact | +335 56 79 87 18 | b.bouyer@chu-bordeaux.fr | |
| Ouidad BEN KACEM | Contact | +335 56 79 87 18 | 14 367 | ouidad.hasnaoui@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin BOUYER, PROF | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux | Recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013124 | Spinal Injuries |
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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)
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| 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 |
| D019567 |
| Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |