Lumbar Spinal Stenosis (LSS)AtrophyLSSNCT04444739
Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis (LSS), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis (LSS)
- What is being tested?
- radiographic data collection
- How many people
- 165 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Feb 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: 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.
- Conditions
- Lumbar Spinal Stenosis (LSS)
- Being tested
- radiographic data collection
- Keywords
- paraspinal muscle atrophy (MA), sagittal pelvic alignment, degenerative spine diseases, stenosis grade (SG), degenerative LSS, Goutallier classification
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiographic data collectionOther
From existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: single time-point at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start3 Feb 2020
- Primary completion30 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal Stenosis (LSS)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, Prof. Dr. med., Principal investigator, Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444739
- Sponsor's protocol ID
- 2020-00150; ch20Muendermann4
- Acronym
- AtrophyLSS
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtrophyLSS - Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT04444739
- Acronym / sponsor ID
- AtrophyLSS / 2020-00150; ch20Muendermann4
- Conditions
- Lumbar Spinal Stenosis (LSS)
- Keywords
- paraspinal muscle atrophy (MA), sagittal pelvic alignment, degenerative spine diseases, stenosis grade (SG), degenerative LSS, Goutallier classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiographic data collectionFrom existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Muendermann, Prof. Dr. med. principal investigator
Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis (LSS), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine (time frame: single time-point at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.