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

Lumbar Spinal Stenosis (LSS)

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

Condition Browse

Acronym

AtrophyLSS

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov