Investigating ATTR Amyloidosis in Patients Undergoing Orthopaedic Surgery
Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease
This study is trying to see how common ATTR amyloid deposits and heart issues are in older patients having surgery for carpal tunnel syndrome, back problems, or hip and knee replacements.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Institut Mutualiste Montsouris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06367842 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of ATTR amyloid deposits and cardiac involvement in patients aged 50 and older who are undergoing surgery for idiopathic carpal tunnel syndrome, lumbar spine stenosis, or total hip or knee arthroplasty due to primary osteoarthritis. The study will analyze surgical samples for amyloid presence using Congo red staining and immunochemistry, and will also evaluate cardiac health through multimodal imaging if ATTR is detected. Additionally, a comprehensive preoperative clinical examination will be conducted to identify predictors of ATTR deposits.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 or older scheduled for surgery related to carpal tunnel syndrome, lumbar spine stenosis, or hip/knee osteoarthritis.
Not a fit: Patients with known amyloidosis or secondary causes of carpal tunnel syndrome will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early diagnosis and management of ATTR cardiopathy in patients undergoing orthopaedic procedures.
How similar studies have performed: While similar studies have explored amyloidosis, this specific approach to correlating orthopaedic surgery with ATTR diagnosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Mutualist Montsouris Institute — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.