Clinical trial NCT06440564: Laser Disinfection in Periprosthetic Joint Infection
Official title: Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periprosthetic Joint Infections
Keywords: Er:YAG laser
biofilm removal
periprosthetic joint infections (PJI)
DAIR
laser disinfection
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Paracelsus Medical University
First posted: 2024-06-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biofil Eradication
timeFrame: 14 days
Secondary outcomes:
measure: Healing Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Clinic of Orthopedics and Trauma Surgery (Paracelus Medical University Salzburg, Austria)
Study officials:
affiliation: Paracelsus Medical University
name: Lukas K Kriechbaumer, MD
role: PRINCIPAL_INVESTIGATOR
References: