Implant FailurePhase 1/2ORTOPLANCT07031999
Use of Biocompatible Thermoplastic Impregnated With Vancomycin as a Temporary Orthopedic Spacer
A Phase 1/2 study testing PLA spacer in people with Implant Failure and Infection, run by Hospital Universitario Evangelico de Curitiba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant Failure, Infection
- What is being tested?
- PLA spacer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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:
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- PLA spacer
- Keywords
- PLA, prosthesis
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLA spacerCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| PLA spacer | Experimental | PLA spacer implantation Receives: Combination Product: PLA spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 months post-implantation
Secondary outcomes (1)
Surgical complications
Measured Variable:
Rate of periprosthetic infection control, defined as the absence of infection signs following spacer implantation.
Definition:
Infection control will be considered achieved when no clinical signs of infection are present (e.g., fever, persistent pain, purulent discharge) by the final evaluation point.
Analysis Metric:
Proportion of patients with complete infection control within 6 months after spacer implantation.
Aggregation Method:
Proportion of patients with successful infection eradication.
Time Point for Analysis:
Monthly follow-up visits for 6 months post-surgery.
Evaluator:
Clinical evaluation will be performed by the orthopedic surgeon during outpatient visits, supported by laboratory tests (when necessary) to confirm infection eradication.
Measured: From enrollment to the end of treatment at 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The interventional group include the use of articular spacer with antibiotic.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Evangelico de Curitiba
- Sponsor type
- University, hospital or other
- Collaborators
- Pontifícia Universidade Católica do Paraná
- Responsible party
- Principal investigator, Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031999
- Sponsor's protocol ID
- ORTOPLA
- Other IDs
- PUCPR
- Acronym
- ORTOPLA
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30069593
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biocompatible Thermoplastic Impregnated With Vancomycin as a Temporary Orthopedic Spacer
- ClinicalTrials.gov ID
- NCT07031999
- Acronym / sponsor ID
- ORTOPLA / ORTOPLA
- Conditions
- Implant Failure, Infection
- Keywords
- PLA, prosthesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario Evangelico de CuritibaUniversity, hospital or other
- Collaborators
- Pontifícia Universidade Católica do Paraná
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The interventional group include the use of articular spacer with antibiotic.
| Arm | Type | Receives |
|---|---|---|
| PLA spacer | Experimental | Combination Product: PLA spacerPLA spacer implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age:
- Patients aged 18 years or older.
- Individuals of all genders are eligible for participation.
- 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.
- Patients or their legal guardians must have signed the Informed Consent Form (ICF), authorizing their participation in the study.
Key exclusion criteria (13 listed)
- Inactive Infection:
- Patients without signs of active prosthetic infection (i.e., no fistula, purulent discharge, or erythema).
- Pregnant or breastfeeding women.
- Solid organ or hematopoietic stem cell transplantation.
- Untreated HIV infection or CD4 count < 350 cells/mm³.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLA spacerThis 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. | Combination product | PLA spacer |
Primary outcome
Control of periprosthetic infection
Time frame: From enrollment to the end of treatment at 6 months post-implantation
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.
1 secondary outcome
Surgical complications
Time frame: From enrollment to the end of treatment at 6 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Results publication: PubMed 30069593Tuon 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.
- Individual participant dataSharing planned: No
Related trials for Implant Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PLA spacer in people with Implant Failure and Infection, run by Hospital Universitario Evangelico de Curitiba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felipe Tuon, PhD (+55 41 988521893, flptuon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of periprosthetic infection (time frame: From enrollment to the end of treatment at 6 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.