NCT03923920

Screening for Systemic Amyloidosis Via the Ligamentum Flavum

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Amyloid
• Amyloidosis
• Spinal Stenosis
• Transthyretin Amyloidosis
• Primary Amyloidosis of Light Chain Type

Interventions

Type	Name	Description
PROCEDURE	Biopsy	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.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-10-04
• Completion: 2021-12-02
• First posted: 2019-04-23
• Last updated: 2021-12-22

Locations

1 site across 1 country: United States