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

June 16, 2021 updated by: University Hospital, Basel, Switzerland

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 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.
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
Time Frame: 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.
single time-point at baseline
Severity of stenosis from supine MRI of lumbar spine
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: single time-point at baseline
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
Time Frame: single time-point at baseline
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

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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