Carpal Tunnel, Transthyretin Amyloidosis
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAnnular 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
Sponsors
Clinique Saint Jean, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | up to 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment and description of the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery. | Perioperative/Periprocedural | 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. |
| Safety Assessment of Ligament Biopsy | up to 24hours | Assess the safety of ligament biopsy, particularly with regard to specific complications. |
Countries
France
Contacts
CONTACTCecile Spirito
Outcome results
None listed