Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02152644 |
| Other study ID # |
1589 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
December 1, 2018 |
Study information
| Verified date |
August 2019 |
| Source |
Hospital Italiano de Buenos Aires |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a cross sectional study to estimate the prevalence of the presence of amyloid
deposits in a biopsy of subcutaneous fat cell, carpal flexor retinaculum and synovial tissue
sheath of the flexor tendons requirement for carpal tunnel surgery.
Description:
Amyloidosis (A) is a disease caused by the deposit of usually misfolded protein in form of
amorphous fibrillar material in different tissues, which may cause their progressive
dysfunction. The prevalence of amyloidosis varies by population studied and the type of
amyloid. Although the prevalence in the general population is unknown, the Mayo Clinic in
U.S. estimated a 1/90666. This disease generated about 0.0084 % (1367/16232579) of total
hospital visits between April 2008 and April 2009 in England.
The most frequent clinical manifestations are cardiac, renal and hepatic involvement, but
vary widely depending on the type of amyloidosis , organ affected and the extent of the
deposits. Infiltration of amyloid may produce signs and symptoms that could be very similar
to other diseases, like the rheumatologic one. This potentially polymorphous clinic
presentation may suggest under-diagnosis by low clinical suspicion.
Carpal tunnel syndrome is frequent in patients with A and may be the initial manifestation.
This syndrome is generated by the progressive infiltration of amyloid fibrils in the
retinaculum flexor and in synovial tissue, causing compression of the medium nerve. A
frequency of up to 13% of carpal tunnel syndrome has been reported in patients with primary
amyloidosis.
In 1993, Breda et al. assessed 98 tendon and synovial tissue's biopsies of patients operated
for carpal tunnel syndrome. The pathology revealed amyloid deposition in 12% of them, of
which 8 had no evidence of systemic disease. This amyloid deposition was interpreted as
probably secondary to chronic local inflammation. In 1992, Kyle et al. evaluated the
incidence of systemic amyloidosis in a retrospective cohort of 35 patients with carpal tunnel
syndrome and synovial local deposition of amyloidosis without evidence of systemic
amyloidosis. During follow-up only 2 developed systemic amyloidosis and 11 showed only
laboratory abnormalities (9 monoclonal band and 2 monoclonal light chain in the urine). In
this group the amyloid deposition was identified as transthyretin (TTR) dependent in 32 of 35
cases.
Even though there are estimations regarding the prevalence of A in general populations
worldwide and in patients with carpal tunnel syndrome surgery, there is no local estimation
in Argentina. Additionally, it is not known if the presentation of amyloid deposits in tendon
elements of pathological the carpal tunnel correlates with subcutaneous amyloid deposit.
In this project the investigators propose to estimate the prevalence of Amyloidosis in the
synovial tissue of patients with surgical carpal tunnel syndrome and correlate them with
deposits of amyloid in the subcutaneous cellular tissue fat.
What is the prevalence of amyloidosis, in cellular subcutaneous fat biopsy, flexor
retinaculum of the carpus and synovial tissue of the flexor tendons sheath, in patients with
carpal tunnel syndrome surgery?
Primary objective
1. To estimate the prevalence of the presence of amyloid deposits in: (i) a biopsy of
cellular subcutaneous fat, (ii) the flexor retinaculum of the carpus and (iii) synovial
tissue of the flexor tendons sheath, with requirement for carpal tunnel surgery.
Secondary objectives
1. Detect and characterize patients with subclinical amyloidosis.
2. Identify the protein deposited in patients with amyloidosis.
