PJIMEGAPJINCT06806449
Results of Silver-coated Resection Prostheses in the Treatment of Periprosthetic Knee Infections with Bone Deficiency
An observational study of PJI, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial summary
The goal of this observational study is to evaluate the infection control and mid-term survival of silver-coated articulated megaprosthetic and knee arthrodesis implants in PJI patients with bone stock deficiency and treated with two-stage protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PJI
- How many people
- 45 participants
- Where
- 3 sitesItaly
- Study dates
- 20 Aug 2023to 11 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at the Orthopedics and Traumatology Operating Unit of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola and other national centers between January 2020 and December 2024 with silver-coated knee megaprosthesis in the two-stage treatment of knee PJI.
Who may be able to join
- Diagnosis of periprosthetic knee infection on primary or already revised implants
- Treatment of infection with two-stage protocol
- Placement of articulated knee megaprosthesis (distal femoral or proximal tibial resection) or arthrodesis, silver-coated.
- Clinical and radiographic follow-up obtained or obtainable greater than or equal to 24 months.
- Completeness of clinical-radiographic documentation
- Obtainment of informed consent
- Age>=18 years
Who cannot join
- Unfit patients
- Patient with a history of oncology
- Patient with contraindications to taking radiographs at follow-up
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Azienda Ospedaliero Universitaria Careggi
Florence, Florence, 50134
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56126
About this study
Official title: Results of Silver-coated Resection Prostheses in the Two-stage Treatment of Periprosthetic Knee Infections with Bone Deficiency
The goal of this observational study is to evaluate the infection control and mid-term survival of silver-coated articulated megaprosthetic and knee arthrodesis implants in PJI patients with bone stock deficiency and treated with two-stage protocol.
Read the detailed description
The majority of studies investigating the outcomes of silver-coated megaprostheses have evaluated case histories of megaprostheses in oncologic patients, while there is little evidence in the Literature of the outcomes of silver-coated megaprostheses in the treatment of infections in non-oncologic patients.
Knowing the mid- to long-term results of this type of implant is of great importance to inform the patient regarding expectations after surgery.
Obtaining more results and data on the treatment of knee PJI with silver-coated megaprostheses could pave the way for the design of prospective randomized comparative trials aimed at establishing the gold standard of treatment.
It is a nonprofit, observational, cohort, retrospective and prospective, multicenter, national study. Patients will be treated according to clinical practice in accordance with the judgment of the clinician.
The biographical and clinical-radiographic data that will be collected are:
- Pre-operative data: timing of infection, bacterial population involved, primary or revision implant (specifying number and type of surgeries and in case of use of implants, number and type of implants), baseline characteristics of the patient (sex, age, date of previous surgeries, number and type of previous surgeries, comorbidities, ASA score, smoking, alcohol, etc.), local knee problems, investigations performed.
- Intra-operative data: The surgical technique will be described with reference to type of access, procedure, type of resection (distal femoral, proximal tibial, both) and length of resection, type of spacer used, sizes of prosthetic components implanted and prosthetic model, possible use of cementation or grafts (specifying nature of graft), possible occurrence of intraoperative complications.
- Postoperative data: antibiotic therapy, results of histological and culture investigations, postoperative complications, implant status at follow-up (specifying in case of failure, the cause of failure), duration of follow-up.
All data and clinical and radiographic material will be collected together and analyzed at IRCCS Azienda Ospedaliero Universitaria di Bologna. All radiographic measurements will be performed by 3 independent operators after evaluation of intra- and inter-observer reliability on 10 random patients.
- Conditions
- PJI
- Keywords
- two-stage treatment, PJI, silver-coated
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection status
absence of clinical radiological and/or laboratory signs of infection or infected.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Incidence of complications unrelated to prosthesis infection in the two different stages of the protocol, also analyzing the number of "first stage" repetitions
Number and type of non-infection-related complications of "first-stage" within 8 weeks and "second-stage" within 24 months
Measured: Within 8 weeks and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start20 Aug 2023
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
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
- Other
- Enrolment
- 45 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
- NCT06806449
- Sponsor's protocol ID
- MEGAPJI
- Acronym
- MEGAPJI
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 4 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Silver-coated Resection Prostheses in the Two-stage Treatment of Periprosthetic Knee Infections with Bone Deficiency
- ClinicalTrials.gov ID
- NCT06806449
- Acronym / sponsor ID
- MEGAPJI / MEGAPJI
- Conditions
- PJI
- Keywords
- two-stage treatment, PJI, silver-coated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 4 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 evaluate the infection control and mid-term survival of silver-coated articulated megaprosthetic and knee arthrodesis implants in PJI patients with bone stock deficiency and treated with two-stage protocol.
Detailed description
The majority of studies investigating the outcomes of silver-coated megaprostheses have evaluated case histories of megaprostheses in oncologic patients, while there is little evidence in the Literature of the outcomes of silver-coated megaprostheses in the treatment of infections in non-oncologic patients.
Knowing the mid- to long-term results of this type of implant is of great importance to inform the patient regarding expectations after surgery.
Obtaining more results and data on the treatment of knee PJI with silver-coated megaprostheses could pave the way for the design of prospective randomized comparative trials aimed at establishing the gold standard of treatment.
It is a nonprofit, observational, cohort, retrospective and prospective, multicenter, national study. Patients will be treated according to clinical practice in accordance with the judgment of the clinician.
The biographical and clinical-radiographic data that will be collected are:
- Pre-operative data: timing of infection, bacterial population involved, primary or revision implant (specifying number and type of surgeries and in case of use of implants, number and type of implants), baseline characteristics of the patient (sex, age, date of previous surgeries, number and type of previous surgeries, comorbidities, ASA score, smoking, alcohol, etc.), local knee problems, investigations performed.
- Intra-operative data: The surgical technique will be described with reference to type of access, procedure, type of resection (distal femoral, proximal tibial, both) and length of resection, type of spacer used, sizes of prosthetic components implanted and prosthetic model, possible use of cementation or grafts (specifying nature of graft), possible occurrence of intraoperative complications.
- Postoperative data: antibiotic therapy, results of histological and culture investigations, postoperative complications, implant status at follow-up (specifying in case of failure, the cause of failure), duration of follow-up.
All data and clinical and radiographic material will be collected together and analyzed at IRCCS Azienda Ospedaliero Universitaria di Bologna. All radiographic measurements will be performed by 3 independent operators after evaluation of intra- and inter-observer reliability on 10 random patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the Orthopedics and Traumatology Operating Unit of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola and other national centers between January 2020 and December 2024 with silver-coated knee megaprosthesis in the two-stage treatment of knee PJI.
Key inclusion criteria (7 listed)
- Diagnosis of periprosthetic knee infection on primary or already revised implants
- Treatment of infection with two-stage protocol
- Placement of articulated knee megaprosthesis (distal femoral or proximal tibial resection) or arthrodesis, silver-coated.
- Clinical and radiographic follow-up obtained or obtainable greater than or equal to 24 months.
- Completeness of clinical-radiographic documentation
Key exclusion criteria (3 listed)
- Unfit patients
- Patient with a history of oncology
- Patient with contraindications to taking radiographs at follow-up
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
Infection status
Time frame: through study completion, an average of 1 year
absence of clinical radiological and/or laboratory signs of infection or infected.
1 secondary outcome
Incidence of complications unrelated to prosthesis infection in the two different stages of the protocol, also analyzing the number of "first stage" repetitions
Time frame: Within 8 weeks and 24 months
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 4 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. This study is not recruiting at the moment.
Andrea Sambri, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 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 3 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 7 inclusion and 3 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 4 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 3 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?
Infection status (time frame: through study completion, an average of 1 year). 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 4 Feb 2025.