NCT04622501

Brief Summary

Introduction Lumbar spinal epidural lipomatosis (SEL) is a rare condition defined by an excessive deposition of adipose tissue in the lumbar spinal canal. The objective of this case report is to document a clinical case of SEL presenting within a multidisciplinary spine clinic and to compare our clinical findings and management with the current literature. Case presentation A 51-year-old female presented at a spine clinic with low back pain, bilateral leg pain and difficulty walking. MR imaging of the lumbar spine showed L4-L5 and L5-S1 degenerative disk disease with evidence of severe central canal stenosis due to extensive epidural lipomatosis. The patient was initially advised to lose weight, undergo a course of physiotherapy, and consult with the pain clinic. Because of lack of improvement, the patient was scheduled for L4-S1 posterior spinal decompression and L4-L5 posterior spinal instrumented fusion. Discussion The discussion will include the diagnosis of SEL, imaging appearance, its risk factors, etiology and management. Conclusion This case report describes a case of lumbar spinal stenosis due to SEL with neurological symptoms. Some risk factors have also been identified in the literature. MRI is considered as the reference standard for its diagnosis. The therapeutic approach of patients with SEL is not standardized. Thus, reporting and investigating the diagnostic process and treatment of this patient will positively contribute to better management for other future patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1 day

First QC Date

August 10, 2020

Last Update Submit

November 10, 2020

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (8)

  • Low back pain

    Visual Pain Scale (0-10)

    3 months before surgery

  • Low back pain

    Visual Pain Scale (0-10)

    6 weeks after surgery

  • Distance Walking

    Distance walking (meter)

    3 months before surgery

  • Distance Walking

    Distance walking (meter)

    6 weeks after surgery

  • Low back pain

    Visual Pain Scale (0-10)

    3 months after surgery

  • Low back pain

    Visual Pain Scale (0-10)

    1 year after surgery

  • Distance walking

    Distance walking (meter)

    3 months after surgery

  • Distance walking

    Distance walking (meter)

    1 year after surgery

Interventions

posterior spinal decompression and posterior spinal instrumented fusionPROCEDURE

posterior spinal decompression and posterior spinal instrumented fusion performed on a patient with Spinal Epidural Lipomatosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients consulting in a multidisciplinary spine clinic

You may qualify if:

  • Adults patient with a clinical diagnosis of Spinal Epidural Lipomatosis (MRI and clinical diagnosis)

You may not qualify if:

  • Absence of clinical diagnosis of Spinal Epidural Lipomatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMCC

Toronto, Ontario, M4T1E5, Canada

Location

Related Publications (10)

  • Borre DG, Borre GE, Aude F, Palmieri GN. Lumbosacral epidural lipomatosis: MRI grading. Eur Radiol. 2003 Jul;13(7):1709-21. doi: 10.1007/s00330-002-1716-4. Epub 2002 Dec 13.

    PMID: 12835988BACKGROUND

  • Fogel GR, Cunningham PY 3rd, Esses SI. Spinal epidural lipomatosis: case reports, literature review and meta-analysis. Spine J. 2005 Mar-Apr;5(2):202-11. doi: 10.1016/j.spinee.2004.05.252.

    PMID: 15795966BACKGROUND

  • Agha RA, Borrelli MR, Farwana R, Koshy K, Fowler AJ, Orgill DP; SCARE Group. The SCARE 2018 statement: Updating consensus Surgical CAse REport (SCARE) guidelines. Int J Surg. 2018 Dec;60:132-136. doi: 10.1016/j.ijsu.2018.10.028. Epub 2018 Oct 18.

    PMID: 30342279BACKGROUND

  • Fassett DR, Schmidt MH. Spinal epidural lipomatosis: a review of its causes and recommendations for treatment. Neurosurg Focus. 2004 Apr 15;16(4):E11.

    PMID: 15191340BACKGROUND

  • Theyskens NC, Paulino Pereira NR, Janssen SJ, Bono CM, Schwab JH, Cha TD. The prevalence of spinal epidural lipomatosis on magnetic resonance imaging. Spine J. 2017 Jul;17(7):969-976. doi: 10.1016/j.spinee.2017.02.010. Epub 2017 Mar 3.

    PMID: 28263890BACKGROUND

  • Yildirim B, Puvanesarajah V, An HS, Novicoff WM, Jain A, Shen FH, Hassanzadeh H. Lumbosacral Epidural Lipomatosis: A Retrospective Matched Case-Control Database Study. World Neurosurg. 2016 Dec;96:209-214. doi: 10.1016/j.wneu.2016.08.125. Epub 2016 Sep 5.

    PMID: 27609448BACKGROUND

  • Kim K, Mendelis J, Cho W. Spinal Epidural Lipomatosis: A Review of Pathogenesis, Characteristics, Clinical Presentation, and Management. Global Spine J. 2019 Sep;9(6):658-665. doi: 10.1177/2192568218793617. Epub 2018 Aug 13.

    PMID: 31448201BACKGROUND

  • Malone JB, Bevan PJ, Lewis TJ, Nelson AD, Blaty DE, Kahan ME. Incidence of spinal epidural lipomatosis in patients with spinal stenosis. J Orthop. 2017 Nov 6;15(1):36-39. doi: 10.1016/j.jor.2017.11.001. eCollection 2018 Mar.

    PMID: 29203971BACKGROUND

  • Walchli B, Benini A. Spinal epidural lipomatosis. Swiss Med Wkly. 2001 Jun 16;131(23-24):359. doi: 10.4414/smw.2001.09739. No abstract available.

    PMID: 11486570BACKGROUND

  • Ferlic PW, Mannion AF, Jeszenszky D, Porchet F, Fekete TF, Kleinstuck F, Haschtmann D. Patient-reported outcome of surgical treatment for lumbar spinal epidural lipomatosis. Spine J. 2016 Nov;16(11):1333-1341. doi: 10.1016/j.spinee.2016.06.022. Epub 2016 Jun 27.

    PMID: 27363757BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

November 10, 2020

Study Start

June 10, 2019

Primary Completion

June 11, 2019

Study Completion

June 10, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

CA(1)