Laser Disinfection in Periprosthetic Joint Infection

NCT ID: NCT06440564

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-05-01

Brief Summary

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The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study we test the suitability of this laser for the removal of biofilms from infected implant surfaces.

Detailed Description

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Infections after joint arthroplasties represent a devastating and progressively escalating complication with increased morbidity and mortality. The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue. In this study the investigators test the suitability of this laser for the removal of biofilms from infected implant surfaces.

Methods In this prospective study, acute or early hematogenous periprosthetic joint infections (PJIs) will be treated with the modified procedure of Debridement, Antibiotics, Laser irradiation and Implant Retention (DALIR). The investigators compare the completeness of biofilm removal from the implant surface with mechanical cleansing alone and the additional use of Er:YAG laser light. Therefore, the investigators will obtain swab cultures from the implants on three distinct occasions: post-arthrotomy, subsequent to mechanical cleansing, and after Er:YAG laser irradiation. The investigators also compare the success rate of the DALIR procedure with the international literature.

Results The investigators expect, that the prevalence of viable microorganisms obtained from implant surfaces through swab cultures will be considerably diminished after additional Er:YAG laser therapy in comparison to only mechanical cleaning with LavaSurge®. The investigators hope to reach a higher healing rate in relation to comparable studies.

Conclusion If the hypothese is correct, the investigators will recommend the use of Er:YAG laser irradiation as an additional tool for disinfection of metal implants in PJIs whenever a DAIR procedure seems to be beneficial.

Conditions

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Periprosthetic Joint Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Er:YAG Laser intervention

In addition to the standard DAIR procedure, laser light is used to disrupt the biofilm from implant surfaced.

Group Type EXPERIMENTAL

Er:YAG Laser irradiation

Intervention Type PROCEDURE

The presented DALIR procedure differs in so far from a standard treatment that after exposure all accessible metal implant surfaces and the adjacent soft tissue is irradiated manually with the Er:YAG laser all over line-by-line with an intended overlap of approximately 10% at constant spot diameter.

Interventions

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Er:YAG Laser irradiation

The presented DALIR procedure differs in so far from a standard treatment that after exposure all accessible metal implant surfaces and the adjacent soft tissue is irradiated manually with the Er:YAG laser all over line-by-line with an intended overlap of approximately 10% at constant spot diameter.

Intervention Type PROCEDURE

Other Intervention Names

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Mechanical cleaning with LavaSurge®

Eligibility Criteria

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Inclusion Criteria

* Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure

Exclusion Criteria

* When a DAIR procedure seems not beneficial in a PJI case.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paracelsus Medical University

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Lukas Kriechbaumer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukas K Kriechbaumer, MD

Role: PRINCIPAL_INVESTIGATOR

Paracelsus Medical University

Locations

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University Clinic of Orthopedics and Trauma Surgery (Paracelus Medical University Salzburg, Austria)

Salzburg, , Austria

Site Status

Countries

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Austria

References

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Kriechbaumer LK, Deininger C, Planitzer A, Mitterer M, Happak W, Nurnberger S, Marko P, Filipp S, Thalhammer G, Frenzel S, Hruby L, Korn G. Laser Disinfection Acts as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI). J Orthop Res. 2025 Jul 23. doi: 10.1002/jor.70035. Online ahead of print.

Reference Type DERIVED
PMID: 40702692 (View on PubMed)

Other Identifiers

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1087/2021

Identifier Type: -

Identifier Source: org_study_id

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