Laser Disinfection in Periprosthetic Joint Infection
Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI)
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 24, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJune 4, 2024
May 1, 2024
2.5 years
May 24, 2024
May 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biofil Eradication
Primary outcome is the comparison of biofilm removal from the implant surface with mechanical cleansing alone (LavaSurge® administered with Pulsavac®) and the additional use of Er:YAG laser light. This is demonstrated by taking microbiological swabs from the implant surface before and after laser treatment.
14 days
Secondary Outcomes (1)
Healing Rate
1 year
Study Arms (1)
Er:YAG Laser intervention
EXPERIMENTALIn addition to the standard DAIR procedure, laser light is used to disrupt the biofilm from implant surfaced.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure
You may not qualify if:
- When a DAIR procedure seems not beneficial in a PJI case.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Viennalead
- Paracelsus Medical Universitycollaborator
Study Sites (1)
University Clinic of Orthopedics and Trauma Surgery (Paracelus Medical University Salzburg, Austria)
Salzburg, 05020, Austria
Related Publications (1)
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. 2026 Jan;44(1):e70035. doi: 10.1002/jor.70035. Epub 2025 Jul 23.
PMID: 40702692DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Lukas K Kriechbaumer, MD
Paracelsus Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 24, 2024
First Posted
June 4, 2024
Study Start
November 1, 2021
Primary Completion
May 1, 2024
Study Completion
May 1, 2025
Last Updated
June 4, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share