NCT07031999

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hospital Universitario Evangelico de Curitiba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

With the progressive aging of the population and the rising number of individuals with degenerative diseases, there has been an increasing indication for joint replacement arthroplasties as a treatment for osteoarthritis in major joints. Knee, hip, and shoulder prostheses have become effective treatment options for joint degeneration, aiming to restore motor function, improve mobility, and relieve pain. In this context, infection remains a major concern, as it can lead to implant removal and the need to replace it with a temporary implant (articular spacer) combined with local antibiotic delivery and systemic antimicrobial therapy-both essential for the complete resolution of the infectious condition. Polylactic acid (PLA) is a biocompatible and biodegradable polymer that can be used in 3D printing technologies to develop customized implants and temporary spacers for the treatment of periprosthetic and bone infections, in addition to its potential application in bone reconstruction. The development of such products through reverse engineering, combined with advanced imaging techniques and specialized computational systems, enables the creation of patient-specific implant models, thus optimizing the recovery process. Therefore, this research project proposes the development and application of a polymer with suitable antimicrobial activity, based on reverse engineering and 3D printing technologies, for the design of orthopedic prostheses and implants. This study aims to address treatment needs in Brazil, where the cost of bone substitutes and articular spacers remains high, especially in orthopedic reconstruction, and where public healthcare systems face challenges in providing adequate and affordable solutions. In this sense, the development of customized, biocompatible, low-cost, and antimicrobial implants may have a significant impact on both patient outcomes and the public health system. This technology is innovative, as it will bring a novel category of medical product to the national market with potential for global reach, thereby representing a substantial advancement in the healthcare field.

Conditions

• Implant Failure
• Infection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PLA spacer	This is a phase 1/2 prospective, interventional, non-randomized, single-arm clinical study designed to evaluate the safety of using temporary articular spacers printed in PLA (polylactic acid) impregnated with vancomycin in patients with periprosthetic infections of the hip, knee, or shoulder.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2025-06-22
• Last updated: 2025-06-22