Clinical trial NCT06367842: Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)
Official title: Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ATTR Amyloidosis
Cardiopathy
Carpal Tunnel Syndrome
Lumbar Spine Stenosis
Hip Prosthesis
Knee Prosthesis
Keywords: ATTR amyloidosis
cardiac amyloidosis
orthopaedic surgery
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients meeting the inclusion criteria in a single orthopaedic surgery center located in Paris, France

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


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

Primary outcomes:
measure: frequency of ATTR amyloidosis
timeFrame: 18 months
Secondary outcomes:
measure: presence of ATTR cardiopathy
timeFrame: 20 months
measure: proportion of wild type and hereditary ATTR
timeFrame: 20 months
measure: Description of preoperative predictors of ATTR
timeFrame: 18 months
measure: Description of preoperative predictors of ATTR
timeFrame: 18 months
measure: preoperative predictors of ATTR
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Mutualist Montsouris Institute
Study officials:
References: