Lower Limb Megaprosthetis InfectionEROMEGANCT07544212
Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses
An observational study of Lower Limb Megaprosthetis Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Lower Limb Megaprosthetis Infection
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2025to 31 Aug 2026
- 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
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
Irccs Azienda Ospedaliero-Universitaria Di Bologna
Bologna, BO, 40138
Sara Tedeschi, +39051 2143353, sara.tedeschi5@unibo.it
About this study
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.
Read the 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.
- Conditions
- Lower Limb Megaprosthetis Infection
- Keywords
- Megaprosthetic Joint Infection, DAIR, MPJI, PJI, Prosthetic Joint Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 months after prosthesis placement
Sex, Charlson index, indication for prosthesis placement, symptoms and etiology of the infection in patients diagnosed with megaprosthesis infection
Measured: 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
Measured: 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
Measured: Within 24 months after prosthesis placement
Sex of patients diagnosed with megaprosthesis infection
Measured: 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
Measured: Within 24 months after prosthesis placement
Percent of patients with megaprosthesis infection who experience clinical failure
Measured: 24 months after prosthesis placement
Charlson index in patients diagnosed with megaprosthesis infection
Measured: During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Dec 2025
- Primary completion31 May 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Megaprosthetis InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SARA TEDESCHI, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544212
- Sponsor's protocol ID
- EROMEGA
- Acronym
- EROMEGA
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses
- ClinicalTrials.gov ID
- NCT07544212
- Acronym / sponsor ID
- EROMEGA / EROMEGA
- Conditions
- Lower Limb Megaprosthetis Infection
- Keywords
- Megaprosthetic Joint Infection, DAIR, MPJI, PJI, Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Apr 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of patients with and without a diagnosis of megaprosthesis infection
Time frame: 24 months after prosthesis placement
Distribution of the study variables in the two groups of patients with and without megaprosthesis infection
8 secondary outcomes
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
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)
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)
Number and type of surgical procedures performed for the treatment of megaprosthesis infection
Time frame: Within 24 months after prosthesis placement
Sex 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)
Number and type (molecule(s), route of administration, dosage, duration) of antibiotic treatments prescribed for the treatment of megaprosthesis infection
Time frame: Within 24 months after prosthesis placement
Percent of patients with megaprosthesis infection who experience clinical failure
Time frame: 24 months after prosthesis placement
Charlson index 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)
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 12 Jun 2026.
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.
SARA TEDESCHI principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Lower Limb Megaprosthetis Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 4 inclusion and 1 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 12 Jun 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 SARA TEDESCHI (+39 051 2143353, sara.tedeschi5@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients with and without a diagnosis of megaprosthesis infection (time frame: 24 months after prosthesis placement). 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 12 Jun 2026.