The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine

Spinal Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127008
• Other study ID #: EFDSC-001
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: November 17, 2015
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Procedure:
• Resection of epidural fat
During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.
• No resection of epidural fat
During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.

Locations

Country	Name	City	State
Korea, Republic of	Armed Forces Yangju Hospital	Yangju	Gyounggido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Postoperative 1 month	No
Secondary	Functional outcomes with Oswestry disability index (ODI) and SF-12	Functional outcome was assessed using ODI and SF-12 at the follow-up times.	postoperative 3 and 12 months	No
Secondary	The extent of epidural fibrosis	the extent of epidural fibrosis was measured with the angle of leg raise at the postoperative 1 month.	Postoperative 1 month	No
Secondary	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.	3, 12 months	No