Spinal StenosisNCT02127008
The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
A study testing Resection of epidural fat and No resection of epidural fat in people with Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Resection of epidural fat and No resection of epidural fat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Stenosis
- Being tested
- Resection of epidural fat, No resection of epidural fat
- Keywords
- epidural fat, resection, spinal stenosis, lumbar spine
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection of epidural fatProcedure or surgery
During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.
No resection of epidural fatProcedure or surgery
During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.
| Study group | Role | What they receive |
|---|---|---|
| Resection of epidural fat | Experimental | During surgical procedure, epidural fat was resected fully. Receives: Procedure: Resection of epidural fat |
| No resection of epidural fat | Active comparator | During surgical procedure, the epidural fat was not resected. Receives: Procedure: No resection of epidural fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative 1 month
Secondary outcomes (3)
Functional outcomes with Oswestry disability index (ODI) and SF-12
Functional outcome was assessed using ODI and SF-12 at the follow-up times.
Measured: postoperative 3 and 12 months
The extent of epidural fibrosis
the extent of epidural fibrosis was measured with the angle of leg raise at the postoperative 1 month.
Measured: 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.
Measured: 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127008
- Sponsor's protocol ID
- EFDSC-001
- Status last verified
- Nov 2015
- First submitted
- 28 Apr 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
- ClinicalTrials.gov ID
- NCT02127008
- Acronym / sponsor ID
- EFDSC-001
- Conditions
- Spinal Stenosis
- Keywords
- epidural fat, resection, spinal stenosis, lumbar spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resection of epidural fat | Experimental | Procedure: Resection of epidural fatDuring surgical procedure, epidural fat was resected fully. |
| No resection of epidural fat | Active comparator | Procedure: No resection of epidural fatDuring surgical procedure, the epidural fat was not resected. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection of epidural fatDuring surgical procedure, the epidural fat with pituitary forcep and rongeur was resected. | Procedure or surgery | Resection of epidural fat |
| No resection of epidural fatDuring surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected. | Procedure or surgery | No resection of epidural fat |
Primary outcome
Pain score on the VAS
Time frame: Postoperative 1 month
Pain intensity at lower back and radiating pain on the lower extremity were separately recorded at postoperative 1 month using visual analogue scale (VAS).
3 secondary outcomes
Functional outcomes with Oswestry disability index (ODI) and SF-12
Time frame: postoperative 3 and 12 months
The extent of epidural fibrosis
Time frame: Postoperative 1 month
The change at postoperative enhanced MRI
Time frame: 3, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resection of epidural fat and No resection of epidural fat in people with Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on the VAS (time frame: Postoperative 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.