AtrophyLSS: Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04444739

Collaborator

(none)

165

Enrollment

Location

10.9

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the correlation between muscle atrophy (MA), sagittal alignment, and stenosis degree in patients with lumbar spinal Stenosis (LSS). From existing radiological images, specific radiographic parameters will be extracted. General Information (Age, sex, levels of stenosis, duration of symptoms) will be extracted from patient files.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spinal Stenosis (LSS)	Other: radiographic data collection

Study Design

Study Type:

Observational

Actual Enrollment :

165 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

AtrophyLSS - Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis

Actual Study Start Date :

Feb 3, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine [single time-point at baseline]
Muscle atrophy stage will be observed using Goutallier classification Stage 0: No fatty infiltration Stage 1: Few fatty streaks within the muscle Stage 2: Less than 50% fat within the muscle Stage 3: 50% of fat within the muscle Stage 4: more than 50% fat with in the muscle. The MA stage will be observed in MRI of 5 lumbar disc levels (L1-S1). The MA stage of patients will be calculated as average stage of five lumbar segments.
Pelvic incidence (PI): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads [single time-point at baseline]
Pelvic incidence (PI): The angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head.
Severity of stenosis from supine MRI of lumbar spine [single time-point at baseline]
Stenosis grade will be observed using Schizas classification (Schizas et al., 2010) Grade 1: Dural sac party occupied by the rootlets; Cerebrospinal fluid clearly visible; No stenosis Grade 2: Rootlets occupy whole dural sac; Some cerebrospinal fluid visible; Moderate stenosis. Grade 3: Rootlets not visible; No cerebrospinal fluid visible; Epidural fat posteriorly; Severe stenosis. Grade 4: Rootlets not visible; No cerebrospinal fluid; No epidural fat; Extreme Stenosis. The most severe level will be regarded as the stenosis grade of the patients.
Pelvic tilt (PT): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads [single time-point at baseline]
Pelvic tilt (PT): The angle formed by a vertical line through the center of the femoral heads and the line from the center of the femoral axis and the midpoint of the sacral end plate.
Sacral slope (SS): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads [single time-point at baseline]
Sacral slope (SS): The angle formed between the horizontal and the sacral end plate.
Lumbar lordosis (LL): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads [single time-point at baseline]
Lumbar lordosis (LL): The sagittal angle formed between the superior end plate of L1 and the sacral end plate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of degenerative lumbar spinal stenosis
Upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral head
MRI of the lumbar region with clear visibility of different muscle atrophy grade
Consent that health related information can be used for research was signed

Exclusion Criteria:

Other spinal disease such as severe scoliosis, fracture, spondylolisthesis and ankylosing spondylitis.
Neuromuscular diseases such as M.Parkinson or multiple sclerosis
Previous surgery of the spine
Infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the spine
Presence of a documented consent dissent.