Prosthetic SurgeryNCT07494344
Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).
An observational study of Prosthetic Surgery and Congenital Coagulation Diseases, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Surgery, Congenital Coagulation Diseases
- What is being tested?
- Prosthetic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 425 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2026to 20 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with MEC
Who may be able to join
- 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.
Who cannot join
- Subjects < 18 years old;
- Subjects with acquired haemorrhagic disorders
- Lack of signed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Gianluigi Pasta, MD, 0382502851, g.pasta@smatteo.pv.it
About this study
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.
- Being tested
- Prosthetic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic SurgeryProcedure or surgery
Prosthetic Surgery in Patients with Congenital Coagulation Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary and secondary prosthesis removal rate in adult's patient population with MAC
Measured: up to 5 years
Secondary outcomes (1)
Peri- and post-operative complications
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Feb 2026
- Primary completion20 Feb 2031 (estimated)
- Study completion20 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Pasta, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494344
- Sponsor's protocol ID
- MEC-SICP
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Retrospective/Prospective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).
- ClinicalTrials.gov ID
- NCT07494344
- Acronym / sponsor ID
- MEC-SICP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Feb 2031 (estimated)
- Study completion
- 20 Feb 2031 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with MEC
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects < 18 years old;
- Subjects with acquired haemorrhagic disorders
- Lack of signed informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic SurgeryProsthetic Surgery in Patients with Congenital Coagulation Diseases | Procedure or surgery | – |
Primary outcome
Primary and secondary prosthesis removal rate in adult's patient population with MAC
Time frame: up to 5 years
1 secondary outcome
Peri- and post-operative complications
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Surgery and Congenital Coagulation Diseases, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluigi Pasta (+39 0382502851, g.pasta@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary and secondary prosthesis removal rate in adult's patient population with MAC (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.