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Implant-Related Infections in Patients With Skeletal Sarcomas

NCT07264296 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-12-04

No results posted yet for this 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%).

Conditions

  • Implant Infection
  • Skeletal Sarcoma
  • Hip Arthritis
  • Prosthesis-Related Infections
  • Knee Arthritis

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • The Swedish Society of Medicine

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Karin Svensson Malchau, PhD · Vastra Gotaland Region

  • Margarita Trobos, Assoc Prof · Göteborg University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2027-06-30
Completion
2028-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264296 on ClinicalTrials.gov