Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)

Carpal Tunnel Syndrome Clinical Trial

— ATTR-ORTHO  

Official title:

Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367842
• Other study ID #: MED-02-2023
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:

1. What is the frequency of ATTR deposits in samples retrieved during surgery?

2. What is the frequency of cardiac involvement in ATTR positive patients?

3. What are the preoperative predictors of ATTR deposits? Participants will

• have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples,

• undergo a multimodal imaging search for cardiac involvement, if ATTR is identified,

• undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis)

• ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.

Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. patients aged 50 or over

2. having signed an informed consent form

3. undergoing surgery for

1. idiopathic carpal tunnel syndrome

2. or lumbar spinal canal stenosis

3. or prosthetic replacement of a hip or knee for primary osteoarthritis

Exclusion Criteria:

1. secondary carpal tunnel syndrome (inflammatory rheumatism, diabetes, hypothyroidism, etc.)

2. Indication of prosthesis for a condition other than primary osteoarthritis.

3. Known amyloidosis

4. Refusal of consent

5. Inability to understand the study

6. Age < 50 years

Related Conditions & MeSH terms

• Amyloidosis
• ATTR Amyloidosis
• Cardiopathy
• Carpal Tunnel Syndrome
• Heart Diseases
• Knee Prosthesis
• Lumbar Spine Stenosis

Locations

Country	Name	City	State
France	Mutualist Montsouris Institute	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of ATTR amyloidosis	presence of ATTR amyloidosis in surgical samples by immunohistochemistry performed when samples countain amyloi by Congo red.ATTR will be semiquantitalively assessed using a published scale.	18 months
Secondary	presence of ATTR cardiopathy	Diagnosis by multimodal imaging(bone scintigraphy, cardiac US scan, MRI)	20 months
Secondary	proportion of wild type and hereditary ATTR	hereditary: patients exibit a mutation of the TTR gene, wild type: no mutation. TTR genotyping will determine if the gene is muted (hereditary ATTR) or not (wild type).	20 months
Secondary	Description of preoperative predictors of ATTR	features more frequent in patients diagnosed with ATTR versus not: - demographic and clinical characteristics,; will be collected before surgery and compared in ATTR positive and ATTR negative patients.	18 months
Secondary	Description of preoperative predictors of ATTR	features more frequent in patients diagnosed with ATTR versus not: - imaging characteristics (USscans of rotator cuff, hip capsula and carpal tunel); will be collected before surgery and compared in ATTR positive and ATTR negative patients.	18 months
Secondary	preoperative predictors of ATTR	biochemical features more frequent in patients diagnosed with ATTR versus not: troponine (g/L); BNP (ng/L); proteuniria (ng/L) will be collected before surgery and compared in ATTR positive and ATTR negative patients.	18 months