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Screening for Systemic Amyloidosis Via the Ligamentum Flavum (ALF)

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Completed

Conditions

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

Treatments

Procedure: Biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT03923920
18-1512

Details and patient eligibility

About

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.

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.

Enrollment

200 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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