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

NCT07544212 | Recruiting

• 1 other identifier: EROMEGA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Megaprosthetis Infection

Keywords

Megaprosthetic Joint Infection; DAIR; MPJI; PJI; Prosthetic Joint Infection

Outcome Measures

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

  24 months after prosthesis placement

Secondary Outcomes (8)

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

  24 months after prosthesis placement

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

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

• Age of patients diagnosed with megaprosthesis infection

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

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

  Within 24 months after prosthesis placement

• Sex of patients diagnosed with megaprosthesis infection

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

Study Arms (1)

Patients who underwent lower-limb megaprosthesis implantation

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

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Irccs Azienda Ospedaliero-Universitaria Di Bologna

Bologna, BO, 40138, Italy

RECRUITING

Study Officials

• SARA TEDESCHI

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SARA TEDESCHI

CONTACT

+39 051 2143353; sara.tedeschi5@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: April 22, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-11

Locations

IT (1)