Lumbar Spinal Stenosis (LSS) Clinical Trial
— AtrophyLSSOfficial title:
AtrophyLSS - Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
| Verified date | June 2021 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 165 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | September 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Orthopaedics and Traumatology, University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |