Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335511
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease Clinical and Biomechanical Outcome Study
Sponsor:
Azienda Usl di Bologna
Organization:
Azienda Usl di Bologna
Study Overview
Official Title:
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease Clinical and Biomechanical Outcome Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCHIMEDE
Brief Summary:
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis
Detailed Description:
Degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact Treatment begins with conservative options physical combined with antalgic therapy but often requires surgical treatment
Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery microsurgical decompression MiD or decompression and instrumented fusion MiD F Clinical and mechanical outcomes of two different treatments MiD vs MiDF will be compared
An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques
The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs to gain the best clinical evidence and possibly reducing the overall costs of management of this disease
Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery microsurgical decompression MiD or decompression and instrumented fusion MiD F Clinical and mechanical outcomes of two different treatments MiD vs MiDF will be compared
An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques
The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs to gain the best clinical evidence and possibly reducing the overall costs of management of this disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None