Screening for Systemic Amyloidosis Via the Ligamentum Flavum

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    200
  • sponsor
    The Cleveland Clinic
Updated on 1 June 2021
stenosis
amyloid
amyloidosis
systemic amyloidosis
amyloid deposits
amyloid deposition
spinal stenosis

Summary

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.

Description

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.

Details
Condition Spinal Stenosis, Amyloidosis, Amyloid, Primary Amyloidosis of Light Chain Type, Cardiac Amyloidosis, Transthyretin Amyloidosis, Primary Amyloidosis, Hereditary Transthyretin Amyloidosis, amyloid deposition, amyloid protein
Treatment biopsy
Clinical Study IdentifierNCT03923920
SponsorThe Cleveland Clinic
Last Modified on1 June 2021

Eligibility

Yes No Not Sure

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
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