The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
Primary Purpose
Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Resection of epidural fat
No resection of epidural fat
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis focused on measuring epidural fat, resection, spinal stenosis, lumbar spine
Eligibility Criteria
Inclusion Criteria:
- patients with a lumbar spinal stenosis, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
- patients who underwent one-level posterior decompression
- patients aging between 20 and 80 years
- patients who volunteered for this study with written consent
- patient who were followed-up for one year or more
Exclusion Criteria:
- fractures, infection, or tumors in the lumbar spine
- patients with hemorrhagic disorders such as hemophilia and thrombocythemia
- patient with a follow-up period of less than one year
- patients who are not suitable for this study judged by the principal investigator
Sites / Locations
- Armed Forces Yangju Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resection of epidural fat
No resection of epidural fat
Arm Description
During surgical procedure, epidural fat was resected fully.
During surgical procedure, the epidural fat was not resected.
Outcomes
Primary Outcome Measures
Pain score on the VAS
Pain intensity at lower back and radiating pain on the lower extremity were separately recorded at postoperative 1 month using visual analogue scale (VAS).
Secondary Outcome Measures
Functional outcomes with Oswestry disability index (ODI) and SF-12
Functional outcome was assessed using ODI and SF-12 at the follow-up times.
The extent of epidural fibrosis
the extent of epidural fibrosis was measured with the angle of leg raise at the postoperative 1 month.
The change at postoperative enhanced MRI
epidural inflammation and postoperative change at the posterior epidural area of the affected segment was evaluated by postoperative enhanced L-spine MRI.
Full Information
NCT ID
NCT02127008
First Posted
April 28, 2014
Last Updated
November 17, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02127008
Brief Title
The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue. Anatomic studies on posterior epidural space and its contents are few, including semifluid property. In other words, there has not been studied thoroughly regarding the significance and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which were free under this layer. The anterior surface of this membrane lay close to the dura mater without any attachment.
To date, the epidural fat has been resected routinely by pituitary forcep and suction drainage during posterior lumbar surgery. However, the investigators focused on the role of epidural fat, which might be associated with postoperative outcome. The investigators thought that this peculiar character, epidural fat, should be caused by certain etiologies. In general, each tissue, such as epidural fat, has its inherited features and significance, thereby the epidural fat has also specific role. However, there has not been fully studies regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural fat on the postoperative outcomes such as pain intensity and functional outcomes by whether the epidural fat would be resected or not during posterior decompressive surgery. The investigators hypothesized that the epidural fat would be associated with postoperative pain intensitive, functional outcomes, and complications of the surgery such as failed back surgery syndrome. In this study, new device for resection of epidural fat was not utilized, but just resected with conventional devices such as pituitary forcep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
epidural fat, resection, spinal stenosis, lumbar spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resection of epidural fat
Arm Type
Experimental
Arm Description
During surgical procedure, epidural fat was resected fully.
Arm Title
No resection of epidural fat
Arm Type
Active Comparator
Arm Description
During surgical procedure, the epidural fat was not resected.
Intervention Type
Procedure
Intervention Name(s)
Resection of epidural fat
Intervention Description
During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.
Intervention Type
Procedure
Intervention Name(s)
No resection of epidural fat
Intervention Description
During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.
Primary Outcome Measure Information:
Title
Pain score on the VAS
Description
Pain intensity at lower back and radiating pain on the lower extremity were separately recorded at postoperative 1 month using visual analogue scale (VAS).
Time Frame
Postoperative 1 month
Secondary Outcome Measure Information:
Title
Functional outcomes with Oswestry disability index (ODI) and SF-12
Description
Functional outcome was assessed using ODI and SF-12 at the follow-up times.
Time Frame
postoperative 3 and 12 months
Title
The extent of epidural fibrosis
Description
the extent of epidural fibrosis was measured with the angle of leg raise at the postoperative 1 month.
Time Frame
Postoperative 1 month
Title
The change at postoperative enhanced MRI
Description
epidural inflammation and postoperative change at the posterior epidural area of the affected segment was evaluated by postoperative enhanced L-spine MRI.
Time Frame
3, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with a lumbar spinal stenosis, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
patients who underwent one-level posterior decompression
patients aging between 20 and 80 years
patients who volunteered for this study with written consent
patient who were followed-up for one year or more
Exclusion Criteria:
fractures, infection, or tumors in the lumbar spine
patients with hemorrhagic disorders such as hemophilia and thrombocythemia
patient with a follow-up period of less than one year
patients who are not suitable for this study judged by the principal investigator
Facility Information:
Facility Name
Armed Forces Yangju Hospital
City
Yangju
State/Province
Gyounggido
Country
Korea, Republic of
12. IPD Sharing Statement
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The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
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