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

NCT07031999 | Not Yet Recruiting Phase 1

• 2 other identifiers: ORTOPLAPUCPR
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

PLA; prosthesis

Outcome Measures

Primary Outcomes (1)

• Control of periprosthetic infection

  Measured Variable: Rate of complications or adverse events, including implant misfit, residual infection, implant rejection, and other adverse outcomes such as wound dehiscence or seroma. Definition: Implant misfit will be defined as the inability of the spacer to properly adapt to the prosthetic defect site, as assessed intraoperatively by the orthopedic surgeon. Residual infection will be characterized by the persistence of clinical signs of infection following spacer implantation (e.g., fistulas, purulent discharge). Analysis Metric: Proportion of patients who experienced any adverse event (e.g., number of patients with residual infection, implant misfit, or other complications). Aggregation Method: Proportion of patients presenting at least one adverse event (e.g., proportion of patients with implant misfit or residual infection). Time Point for Analysis: Assessment following spacer implantation, with follow-up extending up to 6 months post-implantation.

  From enrollment to the end of treatment at 6 months post-implantation

Secondary Outcomes (1)

• Surgical complications

  From enrollment to the end of treatment at 6 months post-implantation

Study Arms (1)

PLA spacer

EXPERIMENTAL

PLA spacer implantation

Combination Product: PLA spacer

Interventions

PLA spacer COMBINATION_PRODUCT

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.

PLA spacer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Evangelico de Curitiba: lead
• Pontifícia Universidade Católica do Paraná: collaborator

Related Publications (1)

• Tuon FF, Cieslinski J, Ono AFM, Goto FL, Machinski JM, Mantovani LK, Kosop LR, Namba MS, Rocha JL. Microbiological profile and susceptibility pattern of surgical site infections related to orthopaedic trauma. Int Orthop. 2019 Jun;43(6):1309-1313. doi: 10.1007/s00264-018-4076-7. Epub 2018 Aug 2.

  PMID: 30069593 BACKGROUND

MeSH Terms

Conditions

Infections

Central Study Contacts

Felipe Tuon, PhD

CONTACT

+55 41 988521893; flptuon@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The interventional group include the use of articular spacer with antibiotic.

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 22, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share