Periprosthetic Joint InfectionsNCT06440564
Laser Disinfection in Periprosthetic Joint Infection
A study testing Er:YAG Laser irradiation in people with Periprosthetic Joint Infections, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periprosthetic Joint Infections
- What is being tested?
- Er:YAG Laser irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2021to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure
Who cannot join
- When a DAIR procedure seems not beneficial in a PJI case.
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Clinic of Orthopedics and Trauma Surgery (Paracelus Medical University Salzburg, Austria)
Salzburg, 05020
About this study
Official title: Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI)
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.
Read the 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.
- Conditions
- Periprosthetic Joint Infections
- Being tested
- Er:YAG Laser irradiation
- Keywords
- Er:YAG laser, biofilm removal, periprosthetic joint infections (PJI), DAIR, laser disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG Laser irradiationProcedure or surgery
Also called Mechanical cleaning with LavaSurge®
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.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG Laser intervention | Experimental | In addition to the standard DAIR procedure, laser light is used to disrupt the biofilm from implant surfaced. Receives: Procedure: Er:YAG Laser irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (1)
Healing Rate
Secondary outcome is infection eradication at 1 year following the DALIR procedure. Success of a DALIR procedure will be determined by the absence of antibiotic administration, lack of clinical indications of infection, and absence of infection related subsequent surgical procedures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Nov 2021
- Primary completion1 May 2024
- Study completion1 May 2025 (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 Periprosthetic Joint InfectionsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University
- Responsible party
- Principal investigator, Lukas Kriechbaumer, Paracelsus Medical University
- Investigators
- Lukas K Kriechbaumer, MD, Principal investigator, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440564
- Sponsor's protocol ID
- 1087/2021
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40702692
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Disinfection as Biofilm-Disrupter in Periprosthetic Joint Infection (PJI)
- ClinicalTrials.gov ID
- NCT06440564
- Acronym / sponsor ID
- 1087/2021
- Conditions
- Periprosthetic Joint Infections
- Keywords
- Er:YAG laser, biofilm removal, periprosthetic joint infections (PJI), DAIR, laser disinfection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 4 Jun 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser intervention | Experimental | Procedure: Er:YAG Laser irradiationIn addition to the standard DAIR procedure, laser light is used to disrupt the biofilm from implant surfaced. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with periprosthetic joint infection (PJI) that will be treated with a debridement, antibiotics, and implant retention (DAIR) procedure
Key exclusion criteria (1 listed)
- When a DAIR procedure seems not beneficial in a PJI case.
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 |
|---|---|---|
| Er:YAG Laser irradiationAlso: Mechanical cleaning with LavaSurge®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. | Procedure or surgery | Er:YAG Laser intervention |
Primary outcome
Biofil Eradication
Time frame: 14 days
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.
1 secondary outcome
Healing Rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 40702692Kriechbaumer 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lukas K Kriechbaumer, MD principal investigator
Paracelsus Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG Laser irradiation in people with Periprosthetic Joint Infections, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofil Eradication (time frame: 14 days). 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 NCT06440564, 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 4 Jun 2024.