Clinical trial NCT04444739: Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
Official title: AtrophyLSS - Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis (LSS)
Keywords: paraspinal muscle atrophy (MA)
sagittal pelvic alignment
degenerative spine diseases
stenosis grade (SG)
degenerative LSS
Goutallier classification
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine
timeFrame: single time-point at baseline
measure: 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
timeFrame: single time-point at baseline
measure: Severity of stenosis from supine MRI of lumbar spine
timeFrame: single time-point at baseline
measure: 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
timeFrame: single time-point at baseline
measure: 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
timeFrame: single time-point at baseline
measure: 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
timeFrame: single time-point at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Orthopaedics and Traumatology, University Hospital Basel
name: Annegret Muendermann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: