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

March 20, 2026 updated by: Gianluigi Pasta, Fondazione IRCCS Policlinico San Matteo di Pavia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients with MEC

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary and secondary prosthesis removal rate in adult's patient population with MAC
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Peri- and post-operative complications
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

February 20, 2031

Study Completion (Estimated)

February 20, 2031

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • MEC-SICP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prosthetic Surgery

Clinical Trials on Prosthetic Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe