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Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).

Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07494344
Enrollment
425
Registered
2026-03-27
Start date
2026-02-20
Completion date
2031-02-20
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Coagulation Diseases, Prosthetic Surgery

Brief summary

The number of hip, knee, shoulder, ankle and elbow prostheses, as well as the amount of economic resources dedicated to this type of intervention, are constantly growing. Prosthetic interventions are not always effective, in some cases they have shown poor results and a high incidence of infections. For rare diseases such as haemophilia and haemophilic arthropathy, collecting retrospective and prospective data is the first step in estimating prevalence or incidence and the opportunity to stimulate future research and to facilitate recruitment into studies. Such studies may present data on the demographic aspects of patients to describe the population receiving the procedures, the patterns of use over time, the risks of review and the outcomes reported by patients. This retrospective/prospective study aims to describe and analyze the risk factors associated with the patient, the surgical technique and obtain outcomes.

Interventions

PROCEDUREProsthetic Surgery

Prosthetic Surgery in Patients with Congenital Coagulation Diseases

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Primary and secondary prosthesis removal rate in adult's patient population with MACup to 5 years

Secondary

MeasureTime frame
Peri- and post-operative complicationsup to 5 years

Countries

Italy

Contacts

CONTACTGianluigi Pasta
g.pasta@smatteo.pv.it+39 0382502851

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026