Actively Recruiting
Evaluation of Ambulatory Endoscopic Spinal Surgery in the Geriatric Population
Led by University Hospital, Bordeaux · Updated on 2024-11-18
50
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. The study focuses on elderly individuals with spinal pathologies, investigating less invasive endoscopic techniques to reduce operative risks and shorten hospital stays, addressing challenges linked to traditional surgeries in this age group. It is a prospective, multicenter, non-interventional study assessing the biportal and uniportal endoscopic approaches' feasibility and effectiveness in this population. The treatment involves endoscopic lumbar decompression surgery using either biportal or uniportal methods, specifically performed as outpatient procedures to minimize surgical trauma and preserve lumbar spine function and stability. Patients will undergo surgery on one lumbar level, with the study observing the outpatient care process without additional interventions. The study is non-interventional and collects data through questionnaires and clinical evaluations. Participants will be followed for three months after surgery to monitor clinical progress, including any complications or hospital readmissions. Data collection includes clinical exams, quality of life assessments, medical histories, ongoing treatments, and self-administered questionnaires. The primary outcome measures the success of outpatient care by tracking hospitalizations or readmissions, while secondary outcomes assess treatment safety and efficacy during inclusion and follow-up visits.
CONDITIONS
Brief Title
Ambulatory Geriatric Endoscopic Spine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged over 75 years.
- Patient consulting for a medical condition involving a spinal pathology at the center, for which endoscopic lumbar decompression on one level is indicated.
You will not qualify if you...
- Patients under guardianship or trusteeship.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo endoscopic lumbar decompression surgery using biportal or uniportal techniques in an outpatient setting to minimize surgical trauma and preserve lumbar spine function.
1 visit (outpatient surgery)
Duration - 3 months
Participants are followed for three months after surgery to monitor clinical improvements and identify any peri- or post-operative complications, including clinical examinations, quality of life assessments, and responses to questionnaires.
1 follow-up visit at 3 months
Trial Site Locations
Total: 4 locations
1
CHU DE Bordeaux
Bordeaux, France
Actively Recruiting
2
Cliniques Terrefort Bordeaux-Bruges
Bruges, France, 33520
Not Yet Recruiting
3
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, France, 24430
Not Yet Recruiting
4
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, France, 24430
Not Yet Recruiting
Research Team
B
Benjamin BOUYER, PROF
S
Sébastien RODRIGUES-FERREIRA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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