Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses (EROMEGA)

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Megaprosthetis Infection

Detailed Description

Megaprostheses are large orthopedic prostheses used to replace extensive portions of bone and joints, typically after the removal of bone tumors or in other conditions involving major bone loss (severe trauma, revisions). In the 1990s, they became the standard for reconstruction following resection of primary malignant bone tumors. Over time, the indications for the use of megaprostheses have expanded to include benign but locally aggressive bone tumors, bone metastases, and malignant soft tissue tumors. Currently, the number of megaprosthesis procedures for non-oncologic conditions is also increasing.

The anatomical sites where a megaprosthesis can be implanted include the femur (proximal, distal, or total), the proximal tibia, and the proximal humerus. Megaprostheses are modular metal structures (titanium, chrome-cobalt) that may include an artificial bone segment, a joint component (hip, knee, shoulder), and potentially an antibacterial coating (such as silver).

While a megaprosthesis represents an important therapeutic option for limb salvage, it also involves complex surgery with significant complication and failure rates. Periprosthetic infection, with incidence rates ranging from 3% to 30%, is certainly one of the most feared complications, as it is associated with increased morbidity and mortality, longer patient recovery times, and higher healthcare costs. Revising a megaprosthesis often presents additional technical challenges for orthopedic surgeons (for example, the impossibility of replacing the implant due to the lack of remaining tissues). Moreover, the rate of infectious complications in megaprostheses is higher than that of periprosthetic infections in standard joint replacements. Possible explanations include longer surgical times, greater soft tissue trauma, or patient-related factors (such as immunocompromised status in oncologic patients).

The use of megaprostheses to treat different types of lower-limb conditions is increasing, and these prostheses carry a higher risk of infection compared to standard implants.

There is a shortage of studies in the literature that specifically and thoroughly analyze risk factors for megaprosthesis infections, and existing studies often involve small patient cohorts.

It is therefore highly rational to identify specific infection risk factors for patients receiving a lower-limb megaprosthesis, if present, to highlight those that may be modifiable and ultimately reduce the infection risk for individual patients. The primary objective of the study is to identify risk factors for the development of infection in lower-limb joint megaprostheses within 2 years of implantation.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: SARA TEDESCHI; Phone Number: +39 051 2143353; Email: sara.tedeschi5@unibo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Sara Tedeschi; Phone Number: +39051 2143353; Email: sara.tedeschi5@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Number and type (molecule(s), route of administration, dosage, duration) of antibiotic treatments prescribed for the treatment of megaprosthesis infection	Within 24 months after prosthesis placement
Percent of patients with megaprosthesis infection who experience clinical failure	24 months after prosthesis placement
Charlson index 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)

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: SARA TEDESCHI, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Actual): May 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Prosthetic Joint Infection; PJI; DAIR; Megaprosthetic Joint Infection; MPJI
• Other Study ID Numbers: EROMEGA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No