Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
self-administered questionnaire
Diagnostic testquality 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)
Treatment groups
15,000 Participants
are divided into 1 treatment groupGroup A: Patient consulting in spine surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 visitSecondary outcomes
1
Clinical characteristics
Weight of patient
Time frame
Inclusion visit, Visit Month 24 and Visit Month 362
Socio-demographic
Socio-demographic characteristics (occupation)
Time frame
Inclusion visit, Visit Month 24 and Visit Month 363
Socio-demographic
Socio-demographic characteristics (sports activities)
Time frame
Inclusion visit, Visit Month 24 and Visit Month 364
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 visitsSponsors and contacts
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Source ClinicalTrials.gov