Implant InfectionIRISSARNCT07264296
Implant-Related Infections in Patients With Skeletal Sarcomas
An observational study of Implant Infection and Skeletal Sarcoma, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The aim of this observational study is to gain knowledge on the microbial and immunological factors behind implant-related infections in patients with skeletal sarcoma. The main research question the project aims to answer is: Are immunological factors more important than microbial factors in peri-prosthetic joint… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implant Infection, Skeletal Sarcoma, Hip Arthritis
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 5 Feb 2025to 31 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Three groups of patients will be studied: * Patients who undergo surgery with a megaprosthesis due to skeletal sarcoma * Patients who have a PJI of a megaprosthesis * Patients who have a PJI after total hip or knee replacement due to osteoarthritis All patients will be recruited consecutively at the Sahlgrenska University Hospital.
Who may be able to join
- Patients diagnosed with skeletal sarcoma planned for primary surgery with resection of tumour and replacement with a megaprosthesis.
- Patients operated with a megaprosthesis due to skeletal sarcoma who develop a peri-prosthetic joint infection (PJI).
- Patients diagnosed with PJI after total hip or knee replacement due to osteoarthritis.
Who cannot join
- None in the group of patients with skeletal sarcoma.
- Patients in the PJI group who have a total hip or knee replacement are excluded if they use immunomodulary medication or have a immunodeficiency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implant-related Infections in Patients With Skeletal Sarcomas
The aim of this observational study is to gain knowledge on the microbial and immunological factors behind implant-related infections in patients with skeletal sarcoma.
The main research question the project aims to answer is:
Read more
- Are immunological factors more important than microbial factors in peri-prosthetic joint infections in orthopaedic oncology patients?
Patients with skeletal sarcoma planned for primary surgery (tumour resection and replacement with a megaprosthesis) will be sampled intraoperatively to obtain a cross-section bone tissue slice at the resection margin, three soft tissue biopsies and joint fluid (if possible). Patients who develop a peri-prosthetic joint infection after their primary surgery will be sampled in a similar manner during revision surgery.
An additional group of patients with periprosthetic joint infection of a hip or knee prosthesis due to osteoarthritis will be sampled during their revision surgery (bone biopsies, soft tissue biopsies and joint fluid, if possible).
Blood samples will be taken from all patients pre-operatively for extensive biochemical and cellular analyses.
Researchers will compare periprosthetic tissues before and after infection. Further, periprosthetic infected tissues in patients treated for skeletal sarcoma will be compared to periprosthetic infected tissues in patientens treated for osteoarthritis. This will be done to attempt to identify host and microbial mechanisms responsible for the increased infection rate in patients with a megaprosthesis due to skeletal sarcoma (infection incidence rate up to 30%) compared to patients with a hip or knee prosthesis due to osteoarthritis (infection incidence rate 1-2%).
Read the detailed description
In orthopaedic oncology, the risk and consequences of orthopaedic device related infections (ODRIs) are heightened as the patients often have compromised immune responses due to underlying disease, chemotherapy or radiation. The implants used may be weight-bearing to the extent that they are impossible to remove or exchange in case of infection, and thereby, in worst case, resulting in amputation or death. Compared to the 1-2% incidence of PJI in a non-oncological population with a total hip- or knee prosthesis, patients with a megaprosthesis due to skeletal sarcoma have an infection incidence of 3-25%. Patient-related factors, extensive and repeated surgery and large reconstructive implants likely account for the increased incidence.
To our knowledge no study has evaluated the role of microbiological factors such as the biofilm production and susceptibility in this population. Further, deficient immunological factors in these patients, such as defect neutrophil migration, cytokine expression and phagocyte respiratory burst, involved in the killing of microbes, may provide an environment favouring more virulent phenotypes. Fundamental knowledge on the role of biofilm in this population could add to the improvement in treatment planning and outcome.
Distinguishing causative pathogens from contaminants may be challenging, especially in polymicrobial infections. The addition of metagenomic diagnostics, still sparsely used in clinical practice, may improve sensitivities, but predictive accuracy is still an issue. Comparing the results of conventional microbiological culturing with metagenomic sequencing would be of interest to determine the accuracy of current diagnostic methods.
The present study is an exploratory project addressing the multifactorial nature of PJI focusing on microbial phenotype in patients with skeletal sarcoma. The role of host, microbe and implant factors will be investigated using a set of different methods and compared to cases och PJI in patients will a conventional hip- or knee prosthesis.
Pre-operative blood samples will be taken and samples of peri-prosthetic soft tissue, bone and joint fluid will be collected intra-operatively. Patients will be sampled during their primary operation with a megaprosthesis due to skeletal sarcoma and in case of postoperative PJI, they will be sampled in the same manner during their revision surgery. Patients undergoing a reoperation due to PJI in a conventional total hip- or knee prosthesis will also be sampled with blood, bone, soft tissue and joint fluid intraoperatively.
Descriptive comparisons between (i) periprosthetic tissues and PJI tissues before and after infection in orthopaedic oncology patients, and (ii) PJI tissues in orthopaedic oncology and conventional PJI patients, will be made in regard to the following parameters:
Role of the host:
- Clinical parameters: ASA-score, diabetes, BMI, age, sex, antibiotic use 2 weeks prior to surgery, duration of chemotherapy, type of chemotherapy, chemotherapy cessation, symptom onset in case of infection, implant type, surgery duration, osteosarcoma type, grade and stage, location of surgery, length of resection.
- Biochemistry in blood (complete white blood cell count with differential, density of neutrophils, CRP, procalcitonin, IL-6).
- Histology and immunohistochemistry (FISH for identification of bacteria, inflammatory infiltrates (presence of foreign body giant cells), angiogenesis, tissue necrosis)
- Gene expression (markers related to angiogenesis, inflammation, microbial recognition and tissue necrosis). In selected paraffin-embedded samples, analysis with spatial transcriptomics will be explored.
Role of the pathogen:
- Five tissue cultures for routine culturing (to determine the causative agent) and one additional for bacterial DNA extraction and 16S rRNA gene sequencing.
- Clinical staphylococcal strains isolated from PJI and tumour endoprosthesis at time of infection will be characterised and compared with respect to their phenotypic biofilm production, antimicrobial susceptibility and presence of virulence genes using CV, MBEC and NGS.
- Difference in gene expression of biofilm-related genes between staphylococcal PJI strains (conventional \& orthopaedic oncology) when grown on titanium with serum pre-conditioning in vitro.
- Conditions
- Implant Infection, Skeletal Sarcoma, Hip Arthritis, Prosthesis-Related Infections, Knee Arthritis
- Keywords
- Biofilm, Periprosthetic joint infection, Skeletal sarcoma
- Medical subject headings
- Osteosarcoma, Prosthesis-Related Infections
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 |
|---|---|---|
| Skeletal sarcoma group | Patients who receive a megaprosthesis as a primary procedure for skeletal sarcoma. | |
| Periprosthetic joint infection after skeletal sarcoma | Patients with a periprosthetic joint infection after surgery with a megaprosthesis due to skeletal sarcoma. | |
| Periprosthetic joint infection after hip/knee replacement due to osteoarthritis | Non-immuncompromised patients with periprosthetic joint infection following a primary total hip or knee replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in virulence properties in causative microbes in the two groups of PJI
A descriptive analysis of genotype will be conducted
Measured: Sampling will occur intraoperatively, bacteria will be frozen, no time frame neccessary
Secondary outcomes (1)
Differences in periprosthetic tissues in the two PJI groups
Descriptive analysis of periprosthetic tissue using histological methods
Measured: Sampling will occur intraoperatively, tissues will be preserved, no time frame neccessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start5 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant InfectionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University, The Swedish Society of Medicine, Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Karin Svensson Malchau, PhD, Principal investigator, Vastra Gotaland RegionMargarita Trobos, Assoc Prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264296
- Sponsor's protocol ID
- 2023-04459-01
- Other IDs
- Dnr 2023-04459-01, 2022-00853, ALFGBG-978896, GLS-973592, LU2021-0048, 2023
- Acronym
- IRISSAR
- Status last verified
- Oct 2025
- First submitted
- 19 May 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The main results will be presented at an aggregated level. In some cases, individual data may be presented (e.g. characteristics of a bacterial strain in relation to clinical outcome), but this information will be unidentified so that it cannot be deduced to the individual. All compiled personal data will be stored on a password-protected hospital server that only the research group has access to. No personal data will be reported in publications. The results of the study will be documented according to the study protocol and placed in a journal. Participants will be coded in a document together with the social security numbers. Information about the participants, their health and the code key will be collected at the Orthopaedic Clinic where it will be treated confidentially and securely for 10 years. The handling of the participants' information is regulated by the Personal Data Act (SFS 1998: 204).
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-related Infections in Patients With Skeletal Sarcomas
- ClinicalTrials.gov ID
- NCT07264296
- Acronym / sponsor ID
- IRISSAR / 2023-04459-01
- Conditions
- Implant Infection, Skeletal Sarcoma, Hip Arthritis, Prosthesis-Related Infections, Knee Arthritis
- Keywords
- Biofilm, Periprosthetic joint infection, Skeletal sarcoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University, The Swedish Society of Medicine, Sahlgrenska University Hospital
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 Dec 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 aim of this observational study is to gain knowledge on the microbial and immunological factors behind implant-related infections in patients with skeletal sarcoma.
The main research question the project aims to answer is:
- Are immunological factors more important than microbial factors in peri-prosthetic joint infections in orthopaedic oncology patients?
Patients with skeletal sarcoma planned for primary surgery (tumour resection and replacement with a megaprosthesis) will be sampled intraoperatively to obtain a cross-section bone tissue slice at the resection margin, three soft tissue biopsies and joint fluid (if possible). Patients who develop a peri-prosthetic joint infection after their primary surgery will be sampled in a similar manner during revision surgery.
An additional group of patients with periprosthetic joint infection of a hip or knee prosthesis due to osteoarthritis will be sampled during their revision surgery (bone biopsies, soft tissue biopsies and joint fluid, if possible).
Blood samples will be taken from all patients pre-operatively for extensive biochemical and cellular analyses.
Researchers will compare periprosthetic tissues before and after infection. Further, periprosthetic infected tissues in patients treated for skeletal sarcoma will be compared to periprosthetic infected tissues in patientens treated for osteoarthritis. This will be done to attempt to identify host and microbial mechanisms responsible for the increased infection rate in patients with a megaprosthesis due to skeletal sarcoma (infection incidence rate up to 30%) compared to patients with a hip or knee prosthesis due to osteoarthritis (infection incidence rate 1-2%).
Detailed description
In orthopaedic oncology, the risk and consequences of orthopaedic device related infections (ODRIs) are heightened as the patients often have compromised immune responses due to underlying disease, chemotherapy or radiation. The implants used may be weight-bearing to the extent that they are impossible to remove or exchange in case of infection, and thereby, in worst case, resulting in amputation or death. Compared to the 1-2% incidence of PJI in a non-oncological population with a total hip- or knee prosthesis, patients with a megaprosthesis due to skeletal sarcoma have an infection incidence of 3-25%. Patient-related factors, extensive and repeated surgery and large reconstructive implants likely account for the increased incidence.
To our knowledge no study has evaluated the role of microbiological factors such as the biofilm production and susceptibility in this population. Further, deficient immunological factors in these patients, such as defect neutrophil migration, cytokine expression and phagocyte respiratory burst, involved in the killing of microbes, may provide an environment favouring more virulent phenotypes. Fundamental knowledge on the role of biofilm in this population could add to the improvement in treatment planning and outcome.
Distinguishing causative pathogens from contaminants may be challenging, especially in polymicrobial infections. The addition of metagenomic diagnostics, still sparsely used in clinical practice, may improve sensitivities, but predictive accuracy is still an issue. Comparing the results of conventional microbiological culturing with metagenomic sequencing would be of interest to determine the accuracy of current diagnostic methods.
The present study is an exploratory project addressing the multifactorial nature of PJI focusing on microbial phenotype in patients with skeletal sarcoma. The role of host, microbe and implant factors will be investigated using a set of different methods and compared to cases och PJI in patients will a conventional hip- or knee prosthesis.
Pre-operative blood samples will be taken and samples of peri-prosthetic soft tissue, bone and joint fluid will be collected intra-operatively. Patients will be sampled during their primary operation with a megaprosthesis due to skeletal sarcoma and in case of postoperative PJI, they will be sampled in the same manner during their revision surgery. Patients undergoing a reoperation due to PJI in a conventional total hip- or knee prosthesis will also be sampled with blood, bone, soft tissue and joint fluid intraoperatively.
Descriptive comparisons between (i) periprosthetic tissues and PJI tissues before and after infection in orthopaedic oncology patients, and (ii) PJI tissues in orthopaedic oncology and conventional PJI patients, will be made in regard to the following parameters:
Role of the host:
- Clinical parameters: ASA-score, diabetes, BMI, age, sex, antibiotic use 2 weeks prior to surgery, duration of chemotherapy, type of chemotherapy, chemotherapy cessation, symptom onset in case of infection, implant type, surgery duration, osteosarcoma type, grade and stage, location of surgery, length of resection.
- Biochemistry in blood (complete white blood cell count with differential, density of neutrophils, CRP, procalcitonin, IL-6).
- Histology and immunohistochemistry (FISH for identification of bacteria, inflammatory infiltrates (presence of foreign body giant cells), angiogenesis, tissue necrosis)
- Gene expression (markers related to angiogenesis, inflammation, microbial recognition and tissue necrosis). In selected paraffin-embedded samples, analysis with spatial transcriptomics will be explored.
Role of the pathogen:
- Five tissue cultures for routine culturing (to determine the causative agent) and one additional for bacterial DNA extraction and 16S rRNA gene sequencing.
- Clinical staphylococcal strains isolated from PJI and tumour endoprosthesis at time of infection will be characterised and compared with respect to their phenotypic biofilm production, antimicrobial susceptibility and presence of virulence genes using CV, MBEC and NGS.
- Difference in gene expression of biofilm-related genes between staphylococcal PJI strains (conventional \& orthopaedic oncology) when grown on titanium with serum pre-conditioning in vitro.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skeletal sarcoma group | – | –Patients who receive a megaprosthesis as a primary procedure for skeletal sarcoma. |
| Periprosthetic joint infection after skeletal sarcoma | – | –Patients with a periprosthetic joint infection after surgery with a megaprosthesis due to skeletal sarcoma. |
| Periprosthetic joint infection after hip/knee replacement due to osteoarthritis | – | –Non-immuncompromised patients with periprosthetic joint infection following a primary total hip or knee replacement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three groups of patients will be studied: * Patients who undergo surgery with a megaprosthesis due to skeletal sarcoma * Patients who have a PJI of a megaprosthesis * Patients who have a PJI after total hip or knee replacement due to osteoarthritis All patients will be recruited consecutively at the Sahlgrenska University Hospital.
Key inclusion criteria (3 listed)
- Patients diagnosed with skeletal sarcoma planned for primary surgery with resection of tumour and replacement with a megaprosthesis.
- Patients operated with a megaprosthesis due to skeletal sarcoma who develop a peri-prosthetic joint infection (PJI).
- Patients diagnosed with PJI after total hip or knee replacement due to osteoarthritis.
Key exclusion criteria (2 listed)
- None in the group of patients with skeletal sarcoma.
- Patients in the PJI group who have a total hip or knee replacement are excluded if they use immunomodulary medication or have a immunodeficiency.
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
Difference in virulence properties in causative microbes in the two groups of PJI
Time frame: Sampling will occur intraoperatively, bacteria will be frozen, no time frame neccessary
A descriptive analysis of genotype will be conducted
1 secondary outcome
Differences in periprosthetic tissues in the two PJI groups
Time frame: Sampling will occur intraoperatively, tissues will be preserved, no time frame neccessary
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 4 Dec 2025.
- Individual participant dataSharing planned: No. The main results will be presented at an aggregated level. In some cases, individual data may be presented (e.g. characteristics of a bacterial strain in relation to clinical outcome), but this information will be unidentified so that it cannot be deduced to the individual. All compiled personal data will be stored on a password-protected hospital server that only the research group has access to. No personal data will be reported in publications. The results of the study will be documented according to the study protocol and placed in a journal. Participants will be coded in a document together with the social security numbers. Information about the participants, their health and the code key will be collected at the Orthopaedic Clinic where it will be treated confidentially and securely for 10 years. The handling of the participants' information is regulated by the Personal Data Act (SFS 1998: 204).
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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.
Karin Svensson Malchau, PhD principal investigator
Vastra Gotaland Region
Margarita Trobos, Assoc Prof principal investigator
Göteborg University
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 Implant Infection and Skeletal Sarcoma, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 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 Sweden. 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?
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?
Difference in virulence properties in causative microbes in the two groups of PJI (time frame: Sampling will occur intraoperatively, bacteria will be frozen, no time frame neccessary). 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 Dec 2025.