Prosthetic joint surgery in adults with congenital bleeding disorders (Italy)
Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).
This project collects past and future data on prosthetic joint surgery in adults with congenital bleeding disorders to see which patient, surgical, and treatment factors relate to outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 425 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07494344 on ClinicalTrials.gov |
What this trial studies
This is a retrospective and prospective observational project conducted at Fondazione IRCCS Policlinico San Matteo in Pavia that collects clinical, surgical, and patient-reported data on hip, knee, shoulder, ankle, and elbow prosthetic procedures in adults with congenital coagulation disorders. Investigators will record demographics, bleeding-disorder subtype and severity, surgical technique, perioperative management, complications including infections and revisions, and resource use. The combined retrospective and prospective approach aims to estimate incidence and describe patterns of use and outcomes over time in this rare population. Results are intended to identify risk factors, inform clinical decision-making, and support future research and trial recruitment.
Who should consider this trial
Good fit: Adults (≥18 years) with congenital coagulation disorders such as haemophilia A or B, von Willebrand disease, or other factor deficiencies who are undergoing prosthetic surgery and can provide informed consent.
Not a fit: Children, patients with acquired bleeding disorders, and those unable or unwilling to sign informed consent are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the project could help identify risk factors and care practices that reduce complications and improve surgical outcomes for patients with bleeding disorders.
How similar studies have performed: Similar registry and observational reports in haemophilia-related arthropathy exist but are limited and show mixed results with higher complication rates, so this work builds on sparse prior data rather than introducing a completely novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients with MEC (in particular Haemophilia A and Haemophilia B, with and without inhibitor, Von Willebrand's disease (VWD), other coagulation factor deficits) * they are undergoing prosthetic surgery * they have signed informed consent. Exclusion Criteria: * Subjects \< 18 years old; * Subjects with acquired haemorrhagic disorders * Lack of signed informed consent.
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Gianluigi Pasta
- Email: g.pasta@smatteo.pv.it
- Phone: +39 0382502851
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.