Periprosthetic Joint Infection (PJI)MOLPJINCT06804265
Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections
An observational study of Periprosthetic Joint Infection (PJI), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection (PJI)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to 30 Apr 2028
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The analysis will be performed on patients treated at the Department of Orthopaedics and Traumatology of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola, from study approval until two years after study approval. The study population will be hip, knee and shoulder joint replacement patients diagnosed with PJI and undergoing prosthetic explantation surgery.
Who may be able to join
- Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant.
- treatment of infection with two-stage protocol.
- Obtaining informed consent
- Age ≥18 years
Who cannot join
- Isolates obtained during explantation not included in MULTIPLEX PCR panel
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, 40138
Massimiliano De Paolis, MD, 0512144332, massimiliano.depaolis@aosp.bo.it
About this study
Official title: Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)
The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. This evaluation will be conducted by comparing the results obtained by Multiplex PCR with those derived from standard culture examination.
Read the detailed description
The data that will be collected are:
- Pre-implantation data: timing of infection, bacterial population involved, type of surgery (primary or revision implantation). Baseline characteristics of patients, such as gender, age, history of previous interventions (including date, number and type of interventions), comorbidities, ASA score, and lifestyle habits (such as smoking and alcohol) will also be recorded. Local problems of the operated limb and investigations performed, including instrumental and laboratory tests, will be documented.
- Data on explant surgery and postoperative course: details of whether or not spacer cement was used according to the two-stage protocol, the type of spacer cement used, the occurrence of intraoperative complications and the characteristics and duration of postoperative antibiotic therapy will be recorded. Results of molecular investigations will be documented, both pre-operative on ultrasound aspirate, intraoperative and 15 days after discontinuation of antibiotic therapy. Results of histological and culture examinations of the preoperative and intraoperative aspirate, postoperative complications will be included.
- Data related to reimplantation: timing of reimplantation, result of molecular, culture, and histological examinations on intraoperative specimens, post-reimplantation antibiotic therapy, intraoperative and postoperative complications, clinical status at follow-up (recurrence/persistence of infection), and duration of follow-up.
- Conditions
- Periprosthetic Joint Infection (PJI)
- Keywords
- Multiplex PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs
comparison with the current diagnostic gold standard, represented by culture examination
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start7 Jan 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint Infection (PJI)Studies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimiliano - De Paolis, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804265
- Sponsor's protocol ID
- MOLPJI
- Acronym
- MOLPJI
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 3 Feb 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)
- ClinicalTrials.gov ID
- NCT06804265
- Acronym / sponsor ID
- MOLPJI / MOLPJI
- Conditions
- Periprosthetic Joint Infection (PJI)
- Keywords
- Multiplex PCR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 3 Feb 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 measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. This evaluation will be conducted by comparing the results obtained by Multiplex PCR with those derived from standard culture examination.
Detailed description
The data that will be collected are:
- Pre-implantation data: timing of infection, bacterial population involved, type of surgery (primary or revision implantation). Baseline characteristics of patients, such as gender, age, history of previous interventions (including date, number and type of interventions), comorbidities, ASA score, and lifestyle habits (such as smoking and alcohol) will also be recorded. Local problems of the operated limb and investigations performed, including instrumental and laboratory tests, will be documented.
- Data on explant surgery and postoperative course: details of whether or not spacer cement was used according to the two-stage protocol, the type of spacer cement used, the occurrence of intraoperative complications and the characteristics and duration of postoperative antibiotic therapy will be recorded. Results of molecular investigations will be documented, both pre-operative on ultrasound aspirate, intraoperative and 15 days after discontinuation of antibiotic therapy. Results of histological and culture examinations of the preoperative and intraoperative aspirate, postoperative complications will be included.
- Data related to reimplantation: timing of reimplantation, result of molecular, culture, and histological examinations on intraoperative specimens, post-reimplantation antibiotic therapy, intraoperative and postoperative complications, clinical status at follow-up (recurrence/persistence of infection), and duration of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The analysis will be performed on patients treated at the Department of Orthopaedics and Traumatology of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola, from study approval until two years after study approval. The study population will be hip, knee and shoulder joint replacement patients diagnosed with PJI and undergoing prosthetic explantation surgery.
Key inclusion criteria (4 listed)
- Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant.
- treatment of infection with two-stage protocol.
- Obtaining informed consent
- Age ≥18 years
Key exclusion criteria (1 listed)
- Isolates obtained during explantation not included in MULTIPLEX PCR panel
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
Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs
Time frame: up to 100 weeks
comparison with the current diagnostic gold standard, represented by culture examination
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 3 Feb 2025.
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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.
Massimiliano - De Paolis, MD 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 Periprosthetic Joint Infection (PJI), 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 3 Feb 2025. 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 Massimiliano De Paolis, MD (0512144332, massimiliano.depaolis@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs (time frame: up to 100 weeks). 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 3 Feb 2025.