- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04444739
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
Conditions
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
-
-
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Basel, Switzerland, 4031
- Orthopaedics and Traumatology, University Hospital Basel
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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
|
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)
|
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
Keywords
Additional Relevant MeSH Terms
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
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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