Clinical trial · Observational
Implant-Related Infections in Patients With Skeletal Sarcomas
Implant-related Infections in Patients With Skeletal Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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%).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hip Arthritis | — | UNRESOLVED | — |
| Implant Infection | — | UNRESOLVED | — |
| Knee Arthritis | — | UNRESOLVED | — |
| Prosthesis-Related Infections | — | UNRESOLVED | — |
| Skeletal Sarcoma | Bone Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Skeletal sarcoma group
- description
- Patients who receive a megaprosthesis as a primary procedure for skeletal sarcoma.
- label
- Periprosthetic joint infection after skeletal sarcoma
- description
- Patients with a periprosthetic joint infection after surgery with a megaprosthesis due to skeletal sarcoma.
- label
- Periprosthetic joint infection after hip/knee replacement due to osteoarthritis
- description
- Non-immuncompromised patients with periprosthetic joint infection following a primary total hip or knee replacement.
Primary outcomes (1)
- measure
- Difference in virulence properties in causative microbes in the two groups of PJI
- timeFrame
- Sampling will occur intraoperatively, bacteria will be frozen, no time frame neccessary
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available