Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-09-18
2026-12-31
Brief Summary
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Detailed Description
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Scientific Justification Spinal pathologies, particularly degenerative conditions of the lumbar spine, are common and lead to significant healthcare costs. With the aging population in developed countries, the incidence of these pathologies is increasing, with 100% of individuals over 60 years old showing structural degenerative changes and 60% experiencing related symptoms. Current surgical treatments, such as conventional lumbar decompression, often result in prolonged hospital stays and high morbidity, particularly among the elderly who typically present with multiple comorbidities, increased bone fragility, and functional limitations. Endoscopic surgery, a less invasive alternative, has demonstrated excellent outcomes in recent studies, including lower complication rates and shorter recovery times. However, its effectiveness in the outpatient setting for the geriatric population remains unstudied.
Treatment/Strategy/Procedure The study involves endoscopic lumbar decompression surgery, utilizing either biportal or uniportal techniques, performed on patients over 75 years old in an outpatient setting. This approach aims to minimize surgical trauma and preserve the physiological function and stability of the lumbar spine.
Follow-Up Patients will be followed for three months post-surgery to monitor clinical improvements and identify any peri- or post-operative complications. Data collected will include clinical examinations, quality of life assessments, medical history, ongoing treatments, and responses to self-administered questionnaires. The follow-up visit at three months will gather comprehensive information on patient progress, including clinical examinations, imaging data, therapeutic interventions, and medication use.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient treated by spinal endoscopy
elderly patients, over 75 years old, treated by spinal endoscopy
Patient treated by spinal endoscopy
Questionnaire administered by surgeon; assessment of level of autonomy for activities of daily living
Interventions
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Patient treated by spinal endoscopy
Questionnaire administered by surgeon; assessment of level of autonomy for activities of daily living
Eligibility Criteria
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Inclusion Criteria
* Patient consulting for a medical condition involving a spinal pathology at the center, for which endoscopic lumbar decompression on one level is indicated.
Exclusion Criteria
* Individuals deprived of liberty by judicial or administrative decision.
* Individuals undergoing psychiatric treatment under constraint requiring consent from a legal representative.
* Individuals admitted to a health or social institution for purposes other than research.
* Individuals unable to give consent.
* Individuals under legal protection.
* Patients not affiliated with a social security system.
* Patients suffering from infectious, traumatic, or tumoral spinal pathology.
75 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Benjamin BOUYER, PROF
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU DE Bordeaux
Bordeaux, , France
Cliniques Terrefort Bordeaux-Bruges
Bruges, , France
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, , France
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2023/92
Identifier Type: -
Identifier Source: org_study_id
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