Implant-Related Infections in Patients With Skeletal Sarcomas

NCT07264296 | Enrolling By Invitation

• 6 other identifiers: 2023-04459-01Dnr 2023-04459-012022-00853ALFGBG-978896GLS-973592LU2021-0048
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biofilm; Periprosthetic joint infection; Skeletal sarcoma

Outcome Measures

Primary Outcomes (1)

• Difference in virulence properties in causative microbes in the two groups of PJI

  A descriptive analysis of genotype will be conducted

  Sampling will occur intraoperatively, bacteria will be frozen, no time frame neccessary

Secondary Outcomes (1)

• Differences in periprosthetic tissues in the two PJI groups

  Sampling will occur intraoperatively, tissues will be preserved, no time frame neccessary

Other Outcomes (1)

• Differences in biofilm production ability between causative microbes in the two PJI groups

  Sampling will occur intraoperatively, bacteria will be frozen, no time frame neccessary

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator
• Sahlgrenska University Hospital: collaborator
• The Swedish Society of Medicine: collaborator

Study Sites (1)

Ortopedi, Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone, blood, joint fluid and tissue samples will be obtained. In the case of infection, bacterial strains will be retained in a biobank.

MeSH Terms

Conditions

Osteosarcoma; Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin Svensson Malchau, PhD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

• Margarita Trobos, Assoc Prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: December 4, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)