Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523426
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Ambulatory Geriatric Endoscopic Spine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Ambulatory Endoscopic Spinal Surgery in the Geriatric Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGES
Brief Summary:
The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old This prospective multicentric non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques specifically biportal and uniportal approaches in reducing operative morbidity and hospital stay duration within this demographic The primary objective is to determine the success rate of outpatient treatment using these endoscopic procedures in elderly patients
Detailed Description:
This study investigates the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old Given the increasing prevalence of spinal pathologies in aging populations traditional surgical approaches pose significant morbidity and extended hospital stays especially for the elderly Recent advancements in less invasive endoscopic techniques offer promising alternatives that may reduce these risks This prospective multicentric non-interventional study aims to evaluate the feasibility and effectiveness of endoscopic lumbar decompression specifically biportal and uniportal approaches in reducing operative morbidity and hospital stay duration within this demographic
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
TreatmentStrategyProcedure 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
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
TreatmentStrategyProcedure 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None