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

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

Sponsors

Lead sponsor: University Hospital, Basel, Switzerland

Source University Hospital, Basel, Switzerland
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.
Overall Status Recruiting
Start Date February 3, 2020
Completion Date February 2021
Primary Completion Date February 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine 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 single time-point at baseline
Severity of stenosis from supine MRI of lumbar spine 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 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 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 single time-point at baseline
Enrollment 600
Condition
Intervention

Intervention type: Other

Intervention name: radiographic data collection

Description: From existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted

Eligibility

Sampling method: Probability Sample

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Annegret Muendermann, Prof. Dr. med. Principal Investigator Orthopaedics and Traumatology, University Hospital Basel
Overall Contact

Last name: Annegret Muendermann, Prof. Dr. med.

Phone: +41 61 328 54 45

Email: [email protected]

Location
facility status contact contact_backup investigator Orthopaedics and Traumatology, University Hospital Basel Annegret Mündermann, Prof. Dr. med. +41 61 328 54 45 [email protected] Cordula Netzer, Dr. med. Sub-Investigator Yuancheng Zhang, Dr. cand. med Sub-Investigator
Location Countries

Switzerland
Verification Date

June 2020
Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym AtrophyLSS
Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov

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