Prosthetic joint surgery in adults with congenital bleeding disorders (Italy)
Official title: Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07494344 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 425 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | February 20, 2026 |
| Main results expected | February 20, 2031 |
| Study ends | February 20, 2031 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07494344 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Gianluigi Pasta
- Email: g.pasta@smatteo.pv.it
- Phone: +39 0382502851
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.