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Carpal Tunnel Release With Risk Factors for Amyloidosis

Sponsor
Henry Ford Health System (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05793320
Collaborator
(none)
250
Enrollment
1
Arm
5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Carpal Tunnel Release Surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carpal Tunnel Release

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Rate of amyloid positivity [Biopsy sent for testing immediately after the procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Henry Ford Health System

Investigators

  • Principal Investigator: Charles Day, MD, Henry Ford Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
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, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT05793320
Other Study ID Numbers:
  • 16239-01
First Posted:
Mar 31, 2023
Last Update Posted:
Mar 31, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Amyloidosis

Study Results

No Results Posted as of Mar 31, 2023