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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis (LSS)
• Intervention / Treatment: Other: radiographic data collection

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who visited Orthopaedics and Traumatology outpatient clinic at University Hospital Basel for clinical and radiological consultation regarding their lumbar spine between 01.01.2018 and 31.12.2019.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine	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.	single time-point at baseline
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	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.	single time-point at baseline
Severity of stenosis from supine MRI of lumbar spine	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.	single time-point at baseline
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	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.	single time-point at baseline
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	Sacral slope (SS): The angle formed between the horizontal and the sacral end plate.	single time-point at baseline
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	Lumbar lordosis (LL): The sagittal angle formed between the superior end plate of L1 and the sacral end plate	single time-point at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Annegret Muendermann, Prof. Dr. med., Orthopaedics and Traumatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: paraspinal muscle atrophy (MA); sagittal pelvic alignment; degenerative spine diseases; stenosis grade (SG); degenerative LSS; Goutallier classification
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Muscular Atrophy; Constriction, Pathologic; Atrophy; Spinal Stenosis
• Other Study ID Numbers: 2020-00150; ch20Muendermann4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No