Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department (SPINDATA)
29 mei 2026 bijgewerkt door: University Hospital, Bordeaux
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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Ingrijpend
Inschrijving (Geschat)
15000
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Benjamin BOUYER, PROF
- Telefoonnummer: +335 56 79 87 18
- E-mail: b.bouyer@chu-bordeaux.fr
Studie Contact Back-up
- Naam: Ouidad BEN KACEM
- Telefoonnummer: 14 367 +335 56 79 87 18
- E-mail: ouidad.hasnaoui@chu-bordeaux.fr
Studie Locaties
-
-
-
Bordeaux, Frankrijk, 33000
- Werving
- Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
-
Contact:
- Ouidad BEN KACEM
- Telefoonnummer: 14 367 +335 56 79 87 18
- E-mail: ouidad.hasnaoui@chu-bordeaux.fr
-
Contact:
- Benjamin BOUYER, MD
- Telefoonnummer: +335 56 79 87 18
- E-mail: b.bouyer@chu-bordeaux.fr
-
Hoofdonderzoeker:
- Benjamin BOUYER, MD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Patient consulting in spine surgery
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)
|
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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Recourse to surgery
Tijdsspanne: Inclusion visit
|
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
|
Inclusion visit
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical characteristics
Tijdsspanne: Inclusion visit, Visit Month 24 and Visit Month 36
|
Weight of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Socio-demographic
Tijdsspanne: Inclusion visit, Visit Month 24 and Visit Month 36
|
Socio-demographic characteristics (occupation)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Socio-demographic
Tijdsspanne: Inclusion visit, Visit Month 24 and Visit Month 36
|
Socio-demographic characteristics (sports activities)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Questionnaire of Quality of life
Tijdsspanne: 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
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Questionnaire of Quality of life
Tijdsspanne: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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.
Tijdsspanne: 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. |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Cervical pain
Tijdsspanne: 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. |
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.
Tijdsspanne: 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). |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Evaluation of the safety of care provided.
Tijdsspanne: 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 |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Clinical characteristics
Tijdsspanne: Inclusion visit, Visit Month 24 and Visit Month 36
|
Body Mass Index of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Evaluation of the safety of care provided.
Tijdsspanne: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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.
Tijdsspanne: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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.
Tijdsspanne: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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.
Tijdsspanne: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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.
Tijdsspanne: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Benjamin BOUYER, PROF, University Hospital, Bordeaux
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
25 mei 2023
Primaire voltooiing (Geschat)
1 augustus 2028
Studie voltooiing (Geschat)
1 augustus 2031
Studieregistratiedata
Eerst ingediend
5 maart 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 mei 2026
Eerst geplaatst (Werkelijk)
4 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
29 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CHUBX 2022/58
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .