Screening for Systemic Amyloidosis Via the Ligamentum Flavum

Completed

• Conditions: Transthyretin Amyloidosis; Amyloidosis; Primary Amyloidosis of Light Chain Type; Amyloid; Spinal Stenosis
• Interventions: Procedure: Biopsy

• Registration Number: NCT03923920
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Study Start: 2019-05-01
• Primary Completion: 2021-10-04
• Status Verified: 2021-12
• Study Completion: 2021-12-02
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Stenosis Biopsy	Biopsy	Biopsy of ligamentum flavum tissue during spinal stenosis surgery sent to pathology for amyloid-specific analysis

Primary Outcome Measures

Name	Time	Method
Incidence of amyloidosis in older patients undergoing spinal stenosis surgery	Baseline to 30 days	Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States