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

Recruiting

• Conditions: Knee Prosthesis; ATTR Amyloidosis; Carpal Tunnel Syndrome; Lumbar Spine Stenosis; Hip Prosthesis; Cardiopathy

• Registration Number: NCT06367842
• Lead Sponsor: Institut Mutualiste Montsouris

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Study First Submitted: 2024-03-06
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of ATTR amyloidosis	18 months	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.

Secondary Outcome Measures

Name	Time	Method
proportion of wild type and hereditary ATTR	20 months	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).
Description of preoperative predictors of ATTR	18 months	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.
presence of ATTR cardiopathy	20 months	Diagnosis by multimodal imaging(bone scintigraphy, cardiac US scan, MRI)
preoperative predictors of ATTR	18 months	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.

Trial Locations

Locations (1)

Mutualist Montsouris Institute; 🇫🇷 Paris, France