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Clinical Trials in Sweden / NCT07264296
Enrolling by invitation Observational

Implant-Related Infections in Patients With Skeletal Sarcomas

NCT07264296 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2025-02-05
Last updated
2025-12-04

Condition(s) studied

Implant InfectionSkeletal SarcomaHip ArthritisProsthesis-Related InfectionsKnee Arthritis

Study 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 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%).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ortopedi, Sahlgrenska University Hospital Gothenburg Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07264296 on ClinicalTrials.gov ↗ ← All trials in Sweden