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

NCT04444739 | Completed

• 1 other identifier: 2020-00150; ch20Muendermann4
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis (LSS)

Keywords

paraspinal muscle atrophy (MA); sagittal pelvic alignment; degenerative spine diseases; stenosis grade (SG); degenerative LSS; Goutallier classification

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

radiographic data collection OTHER

From existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Annegret Muendermann, Prof. Dr. med.

  Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 24, 2020
• Study Start: February 3, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

CH (1)