Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prosthetic Surgery.
- Who it may be relevant to
- Registry conditions: Prosthetic Surgery, Congenital Coagulation Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Prosthetic Surgery
Prosthetic Surgery in Patients with Congenital Coagulation Diseases
Primary outcome measures
- Primary and secondary prosthesis removal rate in adult's patient population with MAC [Time frame: up to 5 years]
Secondary outcome measures (1)
- Peri- and post-operative complications [Time frame: up to 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo — Pavia
Identifiers
NCT: NCT07494344 · MEC-SICP