NCT07264296Enrolling by invitation
Implant-Related Infections in Patients With Skeletal Sarcomas
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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%).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 19 May 2025
- Start date
- 5 Feb 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07264296
What you commit to
- Study type: Observational
- Planned participants: 40
- From 5 Feb 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients in the PJI group who have a total hip or knee replacement are excluded if they use immunomodulary medication or have a immunodeficiency.
Other
- None in the group of patients with skeletal sarcoma.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ortopedi, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.