Infections after lower-limb megaprostheses: risk factors and outcomes
Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses
This project looks at medical records of people aged 14 and older who received a lower-limb megaprosthesis between January 1, 2020 and June 30, 2023 to see what factors are linked to infection and how those infections turned out.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 14 Years to 100 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT07544212 on ClinicalTrials.gov |
What this trial studies
This is a retrospective multicenter observational project including consecutive patients who received a lower-limb megaprosthesis at participating centers between January 1, 2020 and June 30, 2023, with at least two years of follow-up. Clinical and surgical data will be extracted from medical records to document infection incidence, timing, suspected risk factors, implant location and type, and any antibacterial coatings. Management approaches (for example DAIR versus revision) and outcomes such as reoperation, limb salvage, functional recovery, and mortality will be recorded. Analyses will aim to quantify infection rates and identify patterns that could inform prevention and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are people age 14 or older who had a lower-limb megaprosthesis implanted at one of the participating centers between January 1, 2020 and June 30, 2023, have at least two years of follow-up, and have given informed consent for their records to be used.
Not a fit: Patients who did not receive a lower-limb megaprosthesis at a participating center, whose surgery fell outside the specified dates, who lack two years of follow-up, or who seek a direct treatment benefit should not expect personal therapeutic benefit from this retrospective data analysis.
Why it matters
Potential benefit: If successful, the results could help surgeons reduce infection risk and choose better management strategies to improve recovery and lower complication rates.
How similar studies have performed: Previous retrospective series and case reports have documented infection rates, risk factors, and outcomes for megaprostheses but findings are variable, so larger multicenter datasets like this one are needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, BO
- Irccs Azienda Ospedaliero-Universitaria Di Bologna — Bologna, Bo, Italy (Recruiting)
Study contacts
- Principal investigator: Sara Tedeschi — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Sara Tedeschi
- Email: sara.tedeschi5@unibo.it
- Phone: +39 051 2143353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.