Carpal Tunnel Release With Risk Factors for Amyloidosis

NCT05793320 | Unknown

• 1 other identifier: 16239-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. One study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. However, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. In our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. All patients with positive biopsy results would be referred to cardiology. Outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Rate of amyloid positivity

  How many patients who participate in study have positive biopsy for amyloidosis.

  Biopsy sent for testing immediately after the procedure

Study Arms (1)

Carpal Tunnel Release

EXPERIMENTAL

Procedure: Carpal Tunnel Release Surgery

Interventions

Carpal Tunnel Release Surgery PROCEDURE

Carpal tunnel release surgery used to take a biopsy to diagnose amyloidosis and determine whether or not carpal tunnel syndrome can predict who's at risk for having amyloidosis.

Carpal Tunnel Release

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Males older than 50 years old and females older than 60 years old are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive screening is defined as two characteristics from Tier 1 or one characteristic from Tier 1 and one from Tier 2 Tier 1
• Male \> 50 years old
• Female \> 60 years old
• Bilateral carpal tunnel symptoms or prior release surgery Tier 2
• Spinal stenosis
• History of biceps tendon rupture
• Atrial fibrillation or flutter (active or previous history)
• Pacemaker
• Congestive heart failure
• Family history of transthyretin amyloidosis (ATTR)

You may not qualify if:

• Unable or unwilling to follow up with cardiology.
• Previous diagnosis of cardiac amyloidosis.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Main Campus

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Charles Day, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Logan Hansen, MD

CONTACT

313-916-2600; lhansen2@hfhs.org

Charles Day, MD

CONTACT

3135956428; cday9@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Chairman & Medical Director, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery & Service Line, Wayne State University School of Medicine, Henry Ford Health

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 31, 2023
• Study Start: August 3, 2023
• Primary Completion: August 3, 2024
• Study Completion: December 3, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)