Amyloid Neuropathy, Carpal TunnelNCT02152644
Prevalence of Amyloidosis and Carpal Tunnel
An observational study of Amyloid Neuropathy, Carpal Tunnel, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Amyloid Neuropathy, Carpal Tunnel
- How many people
- 0 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate or to the process of informed consent.
- Secondary acute carpal tunnel syndrome (eg ganglion).
- Formal contraindication surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Amyloidosis in Carpal Tunnel Surgery
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.
Read the 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
- 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
- Detect and characterize patients with subclinical amyloidosis.
- Identify the protein deposited in patients with amyloidosis.
- Conditions
- Amyloid Neuropathy, Carpal Tunnel
- Keywords
- amyloidosis-carpal tunnel
- Medical subject headings
- Amyloid Neuropathies, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of amyloid deposits
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study start1 Jun 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2018
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid Neuropathy, Carpal TunnelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Adela Aguirre, MD, Principal investigator, Hospital Italiano de Buenos AiresLourdes Posadas-Martínez, MD, Principal investigator, Hospital Italiano de Buenos AiresDorotea Fantl, MD, Principal investigator, Hospital Italiano de Buenos AiresMaría S. Saez, BCH, Principal investigator, Hospital Italiano de Buenos AiresGustavo Greloni, MD, Principal investigator, Hospital Italiano de Buenos AiresFederico Varela, MD, Principal investigator, Hospital Italiano de Buenos AiresPatricia Sorroche, BCH, Principal investigator, Hospital Italiano de Buenos AiresGabriel Waisman, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152644
- Sponsor's protocol ID
- 1589
- Status last verified
- Aug 2019
- First submitted
- 1 Apr 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Amyloidosis in Carpal Tunnel Surgery
- ClinicalTrials.gov ID
- NCT02152644
- Acronym / sponsor ID
- 1589
- Conditions
- Amyloid Neuropathy, Carpal Tunnel
- Keywords
- amyloidosis-carpal tunnel
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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
- Detect and characterize patients with subclinical amyloidosis.
- Identify the protein deposited in patients with amyloidosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal to participate or to the process of informed consent.
- Secondary acute carpal tunnel syndrome (eg ganglion).
- Formal contraindication surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence of amyloid deposits
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Related trials for Amyloid Neuropathy, Carpal Tunnel
RecruitingObservational study
ATTR Cardiac Amyloidosis in a Selected Population
ATTR Amyloidosis Wild Type, ATTR Gene Mutation
Enrolling by invitationPhase 2
124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome
Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS)
Recruiting
Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy
Carpal Tunnel, Transthyretin Amyloidosis
Not yet recruiting
Early Screening for Cardiac Amyloid Using a History of Bilateral Carpal Tunnel Syndrome
Bilateral Carpal Tunnel Syndrome (Diagnosis), Cardiac Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adela Aguirre, MD principal investigator
Hospital Italiano de Buenos Aires
Lourdes Posadas-Martínez, MD principal investigator
Hospital Italiano de Buenos Aires
Dorotea Fantl, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloid Neuropathy, Carpal Tunnel, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of amyloid deposits (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.