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Prevalence of Amyloidosis and Carpal Tunnel

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ClinicalTrials.gov Identifier: NCT02152644
Recruitment Status : Unknown
Verified December 2015 by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2014
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

Brief 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.

Condition or disease
Amyloid Neuropathy, Carpal Tunnel

Detailed 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.

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Amyloidosis in Carpal Tunnel Surgery
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017


Group/Cohort
amyloid
unique cohort of Adult patients older than 21 years with carpal tunnel syndrome with surgical indication (moderate to severe symptoms that do not respond to conservative treatment physiotherapy, splinting, activity modification) for more than 6 months.



Primary Outcome Measures :
  1. presence of amyloid deposits [ Time Frame: one month ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients older than 21 years with carpal tunnel syndrome with surgical indication (moderate to severe symptoms that do not respond to conservative treatment physiotherapy, splinting, activity modification) for more than 6 months.
Criteria

Inclusion Criteria:

  • Adult patients older than 21 years with carpal tunnel syndrome with surgical indication (moderate to severe symptoms that do not respond to conservative treatment physiotherapy, splinting, activity modification) for more than 6 months.

Exclusion Criteria:

  • Refusal to participate or to the process of informed consent.
  • Secondary acute carpal tunnel syndrome (eg ganglion).
  • Formal contraindication surgical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152644


Contacts
Contact: Diego Giunta, MD 54-11-9590200 ext 4419
Contact: Maria Lourdes Posadas-MArtienz, MD 54-11-9590200 ext 4419

Locations
Argentina
HIBA Not yet recruiting
Caba, Buenos Aires, Argentina
Contact: HIBA    54-11-49590200 ext 4419      
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Adela Aguirre, MD Hospital Italiano de Buenos Aires
Principal Investigator: Lourdes Posadas-Martínez, MD Hospital Italiano de Buenos Aires
Principal Investigator: Dorotea Fantl, MD Hospital Italiano de Buenos Aires
Principal Investigator: María S. Saez, BCH Hospital Italiano de Buenos Aires
Principal Investigator: Gustavo Greloni, MD Hospital Italiano de Buenos Aires
Principal Investigator: Federico Varela, MD Hospital Italiano de Buenos Aires
Principal Investigator: Patricia Sorroche, BCH Hospital Italiano de Buenos Aires
Principal Investigator: Gabriel Waisman, MD Hospital Italiano de Buenos Aires
Principal Investigator: Fernán G. De Quiros, MD Hospital Italiano de Buenos Aires
Principal Investigator: Jorge Boretto, MD Hospital Italiano de Buenos Aires
Principal Investigator: Elsa Nucifora, MD Hospital Italiano de Buenos Aires
Principal Investigator: Diego Giunta, MD Hospital Italiano de Buenos Aires

Responsible Party: Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02152644     History of Changes
Other Study ID Numbers: 1589
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

Keywords provided by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires:
amyloidosis-carpal tunnel

Additional relevant MeSH terms:
Amyloidosis
Carpal Tunnel Syndrome
Amyloid Neuropathies
Proteostasis Deficiencies
Metabolic Diseases
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries