Carpal Tunnel Release With Risk Factors for Amyloidosis

Not Applicable

Recruiting

• Conditions: Amyloidosis
• Interventions: Procedure: Carpal Tunnel Release Surgery

• Registration Number: NCT05793320
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-03-31
• Study Start: 2023-08-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-08-03
• Study Completion: 2024-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carpal Tunnel Release	Carpal Tunnel Release Surgery	-

Primary Outcome Measures

Name	Time	Method
Rate of amyloid positivity	Biopsy sent for testing immediately after the procedure	How many patients who participate in study have positive biopsy for amyloidosis.

Trial Locations

Locations (1)

Henry Ford Main Campus; 🇺🇸 Detroit, Michigan, United States