Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy (ATTR2026)

Assessment of Diagnostic Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy in Patients Who Underwent Endoscopic Carpal Tunnel Syndrome Surgery

Transthyretin amyloidosis (ATTR) is an underdiagnosed condition that can present early as carpal tunnel syndrome, sometimes preceding cardiac involvement by several years. The recent emergence of new treatments underscores the importance of early diagnosis. Synovial biopsy performed during open carpal tunnel surgery is considered the gold standard for local screening, but it is less accessible, more difficult, and riskier to perform via endoscopy-a minimally invasive surgical technique that is currently the standard at our center and is becoming increasingly widespread.

The anterior annular ligament of the carpus constitutes an alternative tissue to the synovium, easily accessible via endoscopy, safe, and standardizable.

In this study, the systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during endoscopic carpal tunnel surgery would allow for the evaluation of the diagnostic concordance of the ligament biopsy by comparing it to the results obtained using the gold standard method. This strategy would also provide an opportunity to analyze the feasibility of systematic screening for ATTR on the ligament during endoscopic procedures.

This approach could offer a practical and innovative method for the early identification of at-risk patients and facilitate appropriate and timely management of the condition.

Study Overview

• Status: Recruiting
• Conditions: Transthyretin Amyloidosis; Carpal Tunnel
• Intervention / Treatment: Diagnostic test: Annular ligament biopsy

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecile Spirito; Phone Number: 0033467413399; Email: cecile.spirito@capsante.fr

Study Locations

• France
  • Montpellier, France, 34430
    • Recruiting
    • Clinique St Jean Sud de france
    • Contact: Cecile Spirito; Phone Number: 00304 67 41 34 53; Email: cecile.spirito@capsante.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient with Health Insurance
• Clinical diagnosis + carpal tunnel EMG
• Validated indication for carpal tunnel surgery
• Signed informed consent
• Patient at risk for postoperative complications (bilateral carpal tunnel syndrome, heart failure, atrial fibrillation, elderly patients)

Exclusion Criteria:

• Need for open carpal tunnel surgery.
• Pregnant women
• Adults under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Annular ligament biopsy in conjunction with a synovial biopsy; For all patients, systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during the surgery	Diagnostic test: Annular ligament biopsy; In addition to the standard synovial biopsy, a biopsy of the annular ligament of the carpus will be performed during endoscopic carpal tunnel surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
agreement between the gold standard and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.	To assess the agreement between the gold standard (synovial biopsy) and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment and description of the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery.	To evaluate and describe the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery. Feasibility will be assessed by the proportion of procedures in which a biopsy specimen of the anterior annular ligament of the carpus can be successfully obtained and submitted for histopathological analysis during endoscopic carpal tunnel surgery.	Perioperative/Periprocedural
Safety Assessment of Ligament Biopsy	Assess the safety of ligament biopsy, particularly with regard to specific complications.	up to 24hours

Collaborators and Investigators

• Sponsor: Clinique Saint Jean, France

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies; Median Neuropathy; Amyloidosis, Hereditary, Transthyretin-Related
• Other Study ID Numbers: 2026-A00378-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No