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Screening for Systemic Amyloidosis Via the Ligamentum Flavum

Screening for Systemic Amyloidosis Via the Ligamentum Flavum

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03923920
Acronym
ALF
Enrollment
200
Registered
2019-04-23
Start date
2019-05-01
Completion date
2021-12-02
Last updated
2021-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Biopsy, Surgery, Screening

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.

Interventions

PROCEDUREBiopsy

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.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of amyloidosis in older patients undergoing spinal stenosis surgeryBaseline to 30 daysIncidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026