Spinal StenosisSPINDATANCT07627282
Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department
A study testing self-administered questionnaire in people with Spinal Stenosis and SPINAL Fracture, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis, SPINAL Fracture, Vertebral Osteomyelitis
- What is being tested?
- self-administered questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2023to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
Benjamin BOUYER, MD, +335 56 79 87 18, b.bouyer@chu-bordeaux.fr
Ouidad BEN KACEM, +335 56 79 87 18 ext. 14 367, ouidad.hasnaoui@chu-bordeaux.fr
About this study
Official title: 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.
Read the 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
- Being tested
- self-administered questionnaire
- Keywords
- spine, care, surgery, evolution
- Medical subject headings
- Spinal Stenosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered questionnaireDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recourse to surgery
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
Measured: Inclusion visit
Secondary outcomes (15)
Clinical characteristics
Weight of patient
Measured: Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic
Socio-demographic characteristics (occupation)
Measured: Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic
Socio-demographic characteristics (sports activities)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Clinical characteristics
Body Mass Index of patient
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start25 May 2023
- Primary completionAug 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin BOUYER, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627282
- Sponsor's protocol ID
- CHUBX 2022/58
- Acronym
- SPINDATA
- Status last verified
- May 2026
- First submitted
- 5 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Evolution of the Quality of Life of Patients Treated by the Spinal Pathology Department
- ClinicalTrials.gov ID
- NCT07627282
- Acronym / sponsor ID
- SPINDATA / CHUBX 2022/58
- Keywords
- spine, care, surgery, evolution
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Patient consulting in spine surgery | Experimental | Diagnostic Test: self-administered questionnairequality 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered questionnairequality 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 | Patient consulting in spine surgery |
Primary outcome
Recourse to surgery
Time frame: Inclusion visit
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
15 secondary outcomes
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
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
Evaluation of the safety of care provided.
Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin BOUYER, PROF principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-administered questionnaire in people with Spinal Stenosis and SPINAL Fracture, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recourse to surgery (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.