Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department (SPINDATA)
29. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
15000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Benjamin BOUYER, PROF
- Telefonnummer: +335 56 79 87 18
- E-post: b.bouyer@chu-bordeaux.fr
Studer Kontakt Backup
- Navn: Ouidad BEN KACEM
- Telefonnummer: 14 367 +335 56 79 87 18
- E-post: ouidad.hasnaoui@chu-bordeaux.fr
Studiesteder
-
-
-
Bordeaux, Frankrike, 33000
- Rekruttering
- Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
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Ta kontakt med:
- Ouidad BEN KACEM
- Telefonnummer: 14 367 +335 56 79 87 18
- E-post: ouidad.hasnaoui@chu-bordeaux.fr
-
Ta kontakt med:
- Benjamin BOUYER, MD
- Telefonnummer: +335 56 79 87 18
- E-post: b.bouyer@chu-bordeaux.fr
-
Hovedetterforsker:
- Benjamin BOUYER, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recourse to surgery
Tidsramme: Inclusion visit
|
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
|
Inclusion visit
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical characteristics
Tidsramme: Inclusion visit, Visit Month 24 and Visit Month 36
|
Weight of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Socio-demographic
Tidsramme: Inclusion visit, Visit Month 24 and Visit Month 36
|
Socio-demographic characteristics (occupation)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Socio-demographic
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Lower back pain.
Tidsramme: 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
|
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Cervical pain
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
|
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Evaluation of the safety of care provided.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Benjamin BOUYER, PROF, University Hospital, Bordeaux
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. mai 2023
Primær fullføring (Antatt)
1. august 2028
Studiet fullført (Antatt)
1. august 2031
Datoer for studieregistrering
Først innsendt
5. mars 2026
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHUBX 2022/58
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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