An interventional study of self-administered questionnaire in Spinal Stenosis, SPINAL Fracture and Vertebral Osteomyelitis, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
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
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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)
Recourse to surgery
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
Time frame: Inclusion visit
Clinical characteristics
Weight of patient
Time frame: Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic
Socio-demographic characteristics (occupation)
Time frame: Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic
Socio-demographic characteristics (sports activities)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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.
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).
Time frame: 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
Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Clinical characteristics
Body Mass Index of patient
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Started May 2023 (actual). Primary completion is estimated for Aug 2028, 63 months after the start.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 63 months is above that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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