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

NCT06367842 | Recruiting

• 1 other identifier: MED-02-2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

ATTR amyloidosis; cardiac amyloidosis; orthopaedic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• presence of ATTR cardiopathy

  20 months

• proportion of wild type and hereditary ATTR

  20 months

• Description of preoperative predictors of ATTR

  18 months

• Description of preoperative predictors of ATTR

  18 months

• preoperative predictors of ATTR

  18 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients meeting the inclusion criteria in a single orthopaedic surgery center located in Paris, France

You may qualify if:

• patients aged 50 or over
• having signed an informed consent form
• undergoing surgery for
• idiopathic carpal tunnel syndrome
• or lumbar spinal canal stenosis
• or prosthetic replacement of a hip or knee for primary osteoarthritis

You may not qualify if:

• secondary carpal tunnel syndrome (inflammatory rheumatism, diabetes, hypothyroidism, etc.)
• Indication of prosthesis for a condition other than primary osteoarthritis.
• Known amyloidosis
• Refusal of consent
• Inability to understand the study
• Age \< 50 years

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Mutualist Montsouris Institute

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Carpal Tunnel Syndrome; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Cardiovascular 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; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Amyloid Neuropathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 16, 2024
• Study Start: February 27, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

FR (1)