Screening for Systemic Amyloidosis Via the Ligamentum Flavum

The investigators will prospectively evaluate for the presence of amyloid deposits in ligamentum flavum (yellow ligament) tissue samples obtained from patients undergoing spinal stenosis surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

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Key information

Conditions

Amyloid Alzheimer Disease Amyloidosis Amyloidosis, Hereditary, Transthyretin-Related Bone Diseases Brain Diseases Central Nervous System Diseases Dementia Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Mental Disorders Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Paraproteinemias Primary Amyloidosis of Light Chain Type Proteostasis Deficiencies Spinal Diseases Spinal Stenosis Tauopathies Transthyretin Amyloidosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Similar to carpal tunnel syndrome, spinal stenosis is associated with systemic amyloidosis and presents earlier than cardiac amyloidosis symptoms - 21-45% of ATTR patients and case reports in AL patients. The investigators' recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 70% of the amyloid-positive group had a history of spinal stenosis and 40% required surgical intervention. Surgical intervention for spinal stenosis could provide an opportunity to screen for amyloidosis through yellow ligament (ligamentum flavum) biopsy.

This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for non-congenital spinal stenosis and spondyloarthropathy. The investigators hypothesize that 10% of such patients will be positive for amyloidosis.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥50 years
Undergoing surgical intervention for non-congenital spinal stenosis and/or spondyloarthropathy
Able to consent

Exclusion criteria

History of congenital spinal stenosis or congenital spondyloarthropathy

Treatment and study plan

Biopsy

Procedure

During clinically-scheduled spinal stenosis surgery, ligamentum flavum tissue (which may contain surrounding tissue and subcutaneous fat) that is removed during the procedure will be sent to pathology to be analyzed with amyloid-specific staining.

Primary outcomes

Incidence of amyloidosis in older patients undergoing spinal stenosis surgery

Time frame: Baseline to 30 days

Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: ALF

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Apr 23, 2019
Registry last updated: Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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