Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-100
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

Retrospective, multicenter, non-profit observational study. The study will include consecutive patients who underwent lower-limb megaprosthesis implantation at the participating Centers between January 1, 2020, and June 30, 2023.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 14 years

Implantation of a lower-limb megaprosthesis at one of the participating centers between January 1, 2020, and June 30, 2023

At least 2 years of follow-up after megaprosthesis implantation

Signed informed consent

Disqualifiers

None

Trial population

All patients aged 14 years or older who underwent implantation of a lower-limb megaprosthesis at the participating Centers between January 1, 2020, and June 30, 2023, will be included.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Patients who underwent lower-limb megaprosthesis implantation

Trial outcomes

Primary outcomes

1

Percent of patients with and without a diagnosis of megaprosthesis infection

Distribution of the study variables in the two groups of patients with and without megaprosthesis infection

Time frame
24 months after prosthesis placement

Secondary outcomes

1

Number of patients diagnosed with lower-limb megaprosthesis infection / number of patients who received a lower-limb megaprosthesis

Time frame
24 months after prosthesis placement
2

Sex, Charlson index, indication for prosthesis placement, symptoms and etiology of the infection in patients diagnosed with megaprosthesis infection

Time frame
During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement)
3

Age of patients diagnosed with megaprosthesis infection

Time frame
During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement)
4

Number and type of surgical procedures performed for the treatment of megaprosthesis infection

Time frame
Within 24 months after prosthesis placement

Other outcomes

Sponsors and contacts

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