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NCT Number: NCT04444739

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.

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Key information

Conditions

Lumbar Spinal Stenosis (LSS) Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: AtrophyLSS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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