Clinical trial NCT02127008: The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Keywords: epidural fat
resection
spinal stenosis
lumbar spine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 185
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain score on the VAS
timeFrame: Postoperative 1 month
Secondary outcomes:
measure: Functional outcomes with Oswestry disability index (ODI) and SF-12
timeFrame: postoperative 3 and 12 months
measure: The extent of epidural fibrosis
timeFrame: Postoperative 1 month
measure: The change at postoperative enhanced MRI
timeFrame: 3, 12 months
Other outcomes:
Locations:
city: Yangju
country: Korea, Republic of
facility: Armed Forces Yangju Hospital
state: Gyounggido
Study officials:
References: