AL Amyloidosis Clinical Trial

Screening for Systemic Amyloidosis Via the Ligamentum Flavum

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

AL Amyloidosis

Estimated Enrollment:

200

Study ID:

NCT03923920

Recruitment Status:

Completed

Sponsor:

The Cleveland Clinic

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There is 1 Location for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Estimated Enrollment:

200

Study ID:

NCT03923920

Recruitment Status:

Completed

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

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