Use of Biocompatible Thermoplastic Impregnated With Vancomycin as a Temporary Orthopedic Spacer

Launched by HOSPITAL UNIVERSITARIO EVANGELICO DE CURITIBA · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of temporary implant made from a special plastic material that is safe for the body and contains the antibiotic vancomycin. This implant is designed to be used when a joint replacement (like a hip, knee, or shoulder) becomes infected and needs to be removed. The temporary implant helps fight the infection while supporting the joint until a permanent replacement can be done. The study aims to create a customized, low-cost, and infection-fighting implant using advanced 3D printing technology, which could improve recovery and make treatment more affordable, especially in public healthcare settings.

Adults who have an active infection around a hip, knee, or shoulder implant and need to have that implant removed may be eligible to join. Participants will need to be willing to attend follow-up visits for about six months after surgery so doctors can monitor their progress. Pregnant women, people without signs of infection, or those with serious immune system problems will not be able to join. If you take part, you can expect to receive this new antibiotic-loaded implant as a temporary spacer while your infection is treated, and healthcare providers will keep track of your healing over time. This is an early-phase study, so it’s focused on testing the safety and usefulness of this innovative treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Age:
• • Patients aged 18 years or older.
• Gender:
• • Individuals of all genders are eligible for participation.
• Indication for Prosthesis Replacement:
• • Patients with an active infection related to a hip, knee, or shoulder prosthesis who require implant removal due to infection and placement of an antibiotic-loaded spacer.
• Informed Consent:
• • Patients or their legal guardians must have signed the Informed Consent Form (ICF), authorizing their participation in the study.
• Active Infection:
• • Patients must present with clinical signs of active periprosthetic infection, such as pain, fever, or purulent discharge at the implant site.
• Willingness for Follow-Up:
• • Patients must be willing to attend outpatient follow-up visits and undergo clinical evaluations over a 6-month postoperative period.
• Exclusion Criteria:
• * Inactive Infection:
• • Patients without signs of active prosthetic infection (i.e., no fistula, purulent discharge, or erythema).
• Pregnancy or Lactation:
• • Pregnant or breastfeeding women.
• Severely Compromised Immunosuppression:
• Patients with conditions that significantly impair the immune system, including:
• • Solid organ or hematopoietic stem cell transplantation.
• • Untreated HIV infection or CD4 count \< 350 cells/mm³.
• • Prolonged use of immunosuppressive therapy (e.g., corticosteroids at doses equivalent to \>0.5 mg/kg/day of prednisone for more than 3 weeks).
• Clinically Incompatible Conditions:
• • Patients with severe or unstable medical conditions that may compromise procedural safety or the ability to adhere to study follow-up.
• Inability to Attend Postoperative Follow-Up:
• • Patients unable to comply with postoperative follow-up visits or telephone consultations due to mobility restrictions or lack of access.