Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615518
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy FELD and Microdiscectomy MD in Patients with Lumbar Disc Herniation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radiological Analysis of MRI Images in Patients Treated with Minimally Invasive Microsurgical and Endoscopic Techniques a Randomized Study Comparing the Clinical Effectiveness of Full Endoscopic Lumbar Discectomy FELD and Microdiscectomy MD
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy FELD and Microdiscectomy MD in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies The main questions it aims to answer are
Does FELD provide superior early postoperative pain relief measured by VAS compared to MD
Does FELD offer better functional recovery measured by COMI and ODI scores postoperatively compared to MD
Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies
Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making
Participants will
Undergo either FELD or MD surgery
Complete VAS COMI and ODI questionnaires at pre-specified follow-up intervals 1 3 6 and 12 months post-surgery
Have MRI scans 24 hours before surgery 24 hours after surgery and at each follow-up to assess disc recurrence residual pathology and to optimize surgical strategies
Does FELD provide superior early postoperative pain relief measured by VAS compared to MD
Does FELD offer better functional recovery measured by COMI and ODI scores postoperatively compared to MD
Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies
Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making
Participants will
Undergo either FELD or MD surgery
Complete VAS COMI and ODI questionnaires at pre-specified follow-up intervals 1 3 6 and 12 months post-surgery
Have MRI scans 24 hours before surgery 24 hours after surgery and at each follow-up to assess disc recurrence residual pathology and to optimize surgical strategies
Detailed Description:
None
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