Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: self-administered questionnaire.
- Who it may be relevant to
- Registry conditions: Spinal Stenosis, SPINAL Fracture, Vertebral Osteomyelitis, Vertebral Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Evolution of the Quality of Life of Patients Treated by the Spinal Pathology Department
Overview
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 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)
Primary outcome measures
- Recourse to surgery [Time frame: Inclusion visit]
Secondary outcome measures (12)
- Clinical characteristics [Time frame: Inclusion visit, Visit Month 24 and Visit Month 36]
- Socio-demographic [Time frame: Inclusion visit, Visit Month 24 and Visit Month 36]
- Socio-demographic [Time frame: Inclusion visit, Visit Month 24 and Visit Month 36]
- Questionnaire of Quality of life [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Questionnaire of Quality of life [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Lower back pain. [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Cervical pain [Time frame: 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. [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Evaluation of the safety of care provided. [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Clinical characteristics [Time frame: Inclusion visit, Visit Month 24 and Visit Month 36]
- Evaluation of the safety of care provided. [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Evaluation of the safety of care provided. [Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux — Bordeaux
Identifiers
NCT: NCT07627282 · CHUBX 2022/58