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

NCT ID: NCT06367842

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2025-09-30

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

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Mutualiste Montsouris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mutualist Montsouris Institute

Paris, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Thomas M Bardin, Pr

Role: primary

thomas.bardin@imm.fr

+33 156616263

Other Identifiers

MED-02-2023

Identifier Type: -

Identifier Source: org_study_id