Carpal Tunnel Release With Risk Factors for Amyloidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-03

Study Completion Date

2024-12-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Carpal Tunnel Release

Group Type EXPERIMENTAL

Carpal Tunnel Release Surgery

Intervention Type 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.

Interventions

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Carpal Tunnel Release Surgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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)

Exclusion Criteria

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Charles S Day

Interim Chairman & Medical Director, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery & Service Line, Wayne State University School of Medicine, Henry Ford Health

Responsibility Role PRINCIPAL_INVESTIGATOR