PJINCT06784414
Analysis of Risk Factors for Recurrence of Periprosthetic Infection in Megaprostheses Implanted for Sarcoma of Bone
An observational study of PJI, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
The goal of this observational study is to collect a large and homogeneous case report of periprosthetic infections in megaprostheses in patients with a history of bone sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PJI
- How many people
- 22 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: All participants meeting the inclusion criteria, processed from 2010 to 2020, were included.
Who may be able to join
- Patients with PJI caused by a megaprosthesis, implanted for a primary sarcoma of bone;
- Age >= 18 years at the time of diagnosis;
- Megaprosthesis site: proximal humerus, proximal femur, total femur, distal femur, tibia proximal;
- Prosthetic revision in two stages;
- Obtaining informed consent for the study
Who cannot join
- Early infection (within 6 weeks after implantation of the prosthesis);
- Recurrence of infection;
- Follow-up < 12 months after prosthetic re-implantation;
- Reconstruction other than a megaprosthesis (e.g., bone graft, composite prosthesis)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
A.O.U Città della Salute e della Scienza di Torino
Torino, 10126
About this study
The goal of this observational study is to collect a large and homogeneous case report of periprosthetic infections in megaprostheses in patients with a history of bone sarcoma.
Read the detailed description
The incidence of periprosthetic infections (PJI) is high in megaprostheses (MP), 3-30% after primary surgery, up to 60% after prosthetic revision. Patients with megaprosthesis implanted in a primary sarcoma of bone have an increased risk of infection, compared with joint prostheses implanted on arthrosis, due to several factors, including treatment with chemotherapy, extensive periarticular soft tissue sacrifice, and duration of surgery. PJI of an MP can result in important consequences: prolonged hospitalizations, expensive treatments, multiple surgeries, risk of amputation and reduced quality of life.
Diagnosis and treatment of MP infections are challenging. Surgery is the focus of treatment, and identification of the microorganism responsible for infection is necessary for diagnostic confirmation and to set up targeted antibiotic treatment.
Treatment, similar to standard joint replacement, includes surgical cleaning without implant replacement and complete revision of the prosthesis in one or two stages. Data currently available in the Literature about patients with infection of a megaprosthesis implanted after excision of a bone sarcoma is scarce; in particular, most case series are small and heterogeneous.
The aim of this study is to obtain more information about this condition by collecting a large and homogeneous data of PJI in MP, in order to identify predictive factors in the treatment of PJI.
The treatments to which the patients underwent and thus analyzed for the study are those expected by normal clinical practice.
- Conditions
- PJI
- Keywords
- megaprosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive factors for infection recurrence in patients with PJI: analysis of demographic, prognostic and treatment data.
Demographic information on disease definition, prognosis, treatments provided and outcomes will be summarised using descriptive methods. treatments provided and outcomes, will be summarised using descriptive methods. In in particular, categorical variables will be summarised by means of relative frequency estimation and 95% confidence intervals; continuous variables will be summarised by means of mean and standard deviation, median and range. standard deviation, median and interquartile range.
Correlations between variables will be investigated: by means of contingency tables and calculation of the chi-square calculation (applying correction for continuity and/or exact test when necessary) for categorical categorical variables; comparison of means (t-test for paired and unpaired data or non-parametric analogues non-parametric when indicated) for variables distributed on an interval scale.
Measured: Data covering the period 2010-2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PJIStudies 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
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Sambri, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784414
- Sponsor's protocol ID
- MEGAINF
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors for Recurrence of Periprosthetic Infection in Megaprostheses Implanted for Sarcoma of Bone
- ClinicalTrials.gov ID
- NCT06784414
- Acronym / sponsor ID
- MEGAINF
- Conditions
- PJI
- Keywords
- megaprosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Jan 2025 (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.
The goal of this observational study is to collect a large and homogeneous case report of periprosthetic infections in megaprostheses in patients with a history of bone sarcoma.
Detailed description
The incidence of periprosthetic infections (PJI) is high in megaprostheses (MP), 3-30% after primary surgery, up to 60% after prosthetic revision. Patients with megaprosthesis implanted in a primary sarcoma of bone have an increased risk of infection, compared with joint prostheses implanted on arthrosis, due to several factors, including treatment with chemotherapy, extensive periarticular soft tissue sacrifice, and duration of surgery. PJI of an MP can result in important consequences: prolonged hospitalizations, expensive treatments, multiple surgeries, risk of amputation and reduced quality of life.
Diagnosis and treatment of MP infections are challenging. Surgery is the focus of treatment, and identification of the microorganism responsible for infection is necessary for diagnostic confirmation and to set up targeted antibiotic treatment.
Treatment, similar to standard joint replacement, includes surgical cleaning without implant replacement and complete revision of the prosthesis in one or two stages. Data currently available in the Literature about patients with infection of a megaprosthesis implanted after excision of a bone sarcoma is scarce; in particular, most case series are small and heterogeneous.
The aim of this study is to obtain more information about this condition by collecting a large and homogeneous data of PJI in MP, in order to identify predictive factors in the treatment of PJI.
The treatments to which the patients underwent and thus analyzed for the study are those expected by normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All participants meeting the inclusion criteria, processed from 2010 to 2020, were included.
Key inclusion criteria (5 listed)
- Patients with PJI caused by a megaprosthesis, implanted for a primary sarcoma of bone;
- Age >= 18 years at the time of diagnosis;
- Megaprosthesis site: proximal humerus, proximal femur, total femur, distal femur, tibia proximal;
- Prosthetic revision in two stages;
- Obtaining informed consent for the study
Key exclusion criteria (4 listed)
- Early infection (within 6 weeks after implantation of the prosthesis);
- Recurrence of infection;
- Follow-up < 12 months after prosthetic re-implantation;
- Reconstruction other than a megaprosthesis (e.g., bone graft, composite prosthesis)
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
Identification of predictive factors for infection recurrence in patients with PJI: analysis of demographic, prognostic and treatment data.
Time frame: Data covering the period 2010-2020.
Demographic information on disease definition, prognosis, treatments provided and outcomes will be summarised using descriptive methods. treatments provided and outcomes, will be summarised using descriptive methods. In in particular, categorical variables will be summarised by means of relative frequency estimation and 95% confidence intervals; continuous variables will be summarised by means of mean and standard deviation, median and range. standard deviation, median and interquartile range. Correlations between variables will be investigated: by means of contingency tables and calculation of the chi-square calculation (applying correction for continuity and/or exact test when necessary) for categorical categorical variables; comparison of means (t-test for paired and unpaired data or non-parametric analogues non-parametric when indicated) for variables distributed on an interval scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Related trials for PJI
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
Not yet recruitingObservational study
Impact of Nutritional Status Before Joint Replacement on Infection Risk
Periprosthetic Joint Infection (PJI), Malnutitrion
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
Periprosthetic Joint Infection (PJI)
Recruiting
Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
Prosthetic Joint Infection (PJI)
RecruitingPhase 2
Periprosthetic Joint Infection Bubble Study
Periprosthetic Joint Infection (PJI)
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. This study is not recruiting at the moment.
Andrea Sambri, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PJI, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive factors for infection recurrence in patients with PJI: analysis of demographic, prognostic and treatment data. (time frame: Data covering the period 2010-2020.). 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 20 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.