NCT Number: NCT07627282
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bordeaux, 33000, France
Location status: Recruiting
Benjamin BOUYER, MD
CONTACT
Benjamin BOUYER, MD
PRINCIPAL_INVESTIGATOR
Ouidad BEN KACEM
CONTACT
+335 56 79 87 18 ext. 14 367
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Inclusion visit
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
Time frame: Inclusion visit, Visit Month 24 and Visit Month 36
Weight of patient
Time frame: Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic characteristics (occupation)
Time frame: Inclusion visit, Visit Month 24 and Visit Month 36
Socio-demographic characteristics (sports activities)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
For each type of spinal pathology, measurement of:
Time frame: Inclusion visit, Visit Month 24 and Visit Month 36
Body Mass Index of patient
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Evaluation of the Evolution of the Quality of Life of Patients Treated by the Spinal Pathology Department
Acronym: SPINDATA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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