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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Subjects < 18 years old;

Subjects with acquired haemorrhagic disorders

Lack of signed informed consent.

Trial population

adult patients with MEC

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Prosthetic Surgery

    Procedure/Surgery

    Prosthetic Surgery in Patients with Congenital Coagulation Diseases

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Primary and secondary prosthesis removal rate in adult's patient population with MAC

Time frame
up to 5 years

Secondary outcomes

1

Peri- and post-operative complications

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

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