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Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department (SPINDATA)

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Bordeaux, Frankrig, 33000
        • Rekruttering
        • Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Benjamin BOUYER, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Diagnostisk 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
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
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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Bordeaux

Efterforskere

  • Ledende efterforsker: Benjamin BOUYER, PROF, University Hospital, Bordeaux

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. maj 2023

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2031

Datoer for studieregistrering

Først indsendt

5. marts 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUBX 2022/58

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