Orthopedic Devices Associated With Misadventures, Prosthetic and Other Implants, Materials and Accessory DevicesNCT03226184
Sterilizing Effects of the Erbium:YAG Laser Upon Metal Implants
An observational study of Orthopedic Devices Associated With Misadventures, Prosthetic and Other Implants, Materials and Accessory Devices, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: Even today, postoperative infection is the commonest complications after surgery although all aseptic precautions are taken and causes significant postoperative morbidity, mortality, prolongs hospital stay, and increases costs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopedic Devices Associated With Misadventures, Prosthetic and Other Implants, Materials and Accessory Devices
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2012to 1 Oct 2017
- Phase
- Observational
- 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
- Child, Adult, Older adult
Study population: same as inclusion criteria
Who may be able to join
- All patients that are treated with external fixators for at least 2 weeks and patients whose implants have to be removed during septic revision surgery.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University Clinic of Traumatology, Medical University of Vienna
Vienna, 1090
Lukas K Kriechbaumer, MD, +43 (0) 5 7255 ext. 57156, lukikriechbaumer@hotmail.com
Wolfgang Happak, Prof. MD, +43 (0)1 40400 ext. 69860
About this study
Background:
Even today, postoperative infection is the commonest complications after surgery although all aseptic precautions are taken and causes significant postoperative morbidity, mortality, prolongs hospital stay, and increases costs. Infections that are related to orthopaedic procedures are considered particularly severe when implantation materials are used which further increases the risk of infection and holds the risk of biofilm formation. This is of particular concern since biofilm-mediated infections are difficult to diagnose and effective treatments are lacking. Therefore, new strategies for implant infection are currently being researched worldwide. In this study the relatively new approach for infection control by using an Er:YAG laser was adapted to an orthopaedic and traumatologic setting. This laser vaporizes all water containing cells in a very effective, precise and predictable manner and shows only a minimal thermal damage.
Read more
Methods:
For preliminary testing 42 steel pins and 42 plates were cultivated with cocultures for 2 weeks. The minimally necessary laser energy for biofilm removal was determined. We subsequently compared the effectiveness of biofilm removal with the Er:YAG laser and a cleansing of the metal implants with Octenidine soaked gauze. The temperature rise within the metal during the laser procedure was also measured.
In order to achieve an approximation to a clinical setting we want to compared the same effectiveness of biofilm removal similarly on steel pins directly after explantation from patients treated with external fixators for at least 2 weeks. Sonication and SEM will be used for analysis.
Preliminary Results Laser fluences exceeding 2.8J/cm2 caused a complete extinction of all living cells by a single laser impulse. Temperature rise within the implant is dependent on repetition frequency but overall negligible.
The effectiveness of biofilm removal after cleansing with Octenidine soaked gauze and irradiation with the Er:YAG laser will be evaluated on cultivated and extracted pins.
Conclusions We want to compare the effectiveness of the Er:YAG laser and Octenidine in the removal of biofilms from half-pins. We hypothesize that thee Er:YAG laser offers a secure, complete and non toxic removal of all kinds of pathogens from steel implants without damaging the implant or possible development of resistances. The precise non-contact removal of adjacent tissue could be an advantage over other disinfectants.
Level of Evidence (II-a)
Clinical Relevance:
Having one more arrow in the quiver for disinfection of percutaneous implants or for septic revision surgery when osteosynthesis equipment or arthroplasties are meant to be left in place would be extremely desirable.
- Keywords
- Er:YAG laser, laser, biofilm removal, biofilm, disinfection, septic revision surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of biofilm removal
Is the Er:YAG laser able to remova a microbial biofilm from cultivated or infected implants
Measured: 2 years
Secondary outcomes (1)
Side effects
Are there side effect to be expected from laser Irradiation either for the implant or for the surrounding tissue in a possible clinical setting
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jul 2012
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Devices Associated With Misadventures, Prosthetic and Other Implants, Materials and Accessory DevicesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 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, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226184
- Sponsor's protocol ID
- 2167/2013
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterilizing Effects of the Erbium:YAG Laser Upon Metal Implants
- ClinicalTrials.gov ID
- NCT03226184
- Acronym / sponsor ID
- 2167/2013
- Keywords
- Er:YAG laser, laser, biofilm removal, biofilm, disinfection, septic revision surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 21 Jul 2017 (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.
Background:
Even today, postoperative infection is the commonest complications after surgery although all aseptic precautions are taken and causes significant postoperative morbidity, mortality, prolongs hospital stay, and increases costs. Infections that are related to orthopaedic procedures are considered particularly severe when implantation materials are used which further increases the risk of infection and holds the risk of biofilm formation. This is of particular concern since biofilm-mediated infections are difficult to diagnose and effective treatments are lacking. Therefore, new strategies for implant infection are currently being researched worldwide. In this study the relatively new approach for infection control by using an Er:YAG laser was adapted to an orthopaedic and traumatologic setting. This laser vaporizes all water containing cells in a very effective, precise and predictable manner and shows only a minimal thermal damage.
Methods:
For preliminary testing 42 steel pins and 42 plates were cultivated with cocultures for 2 weeks. The minimally necessary laser energy for biofilm removal was determined. We subsequently compared the effectiveness of biofilm removal with the Er:YAG laser and a cleansing of the metal implants with Octenidine soaked gauze. The temperature rise within the metal during the laser procedure was also measured.
In order to achieve an approximation to a clinical setting we want to compared the same effectiveness of biofilm removal similarly on steel pins directly after explantation from patients treated with external fixators for at least 2 weeks. Sonication and SEM will be used for analysis.
Preliminary Results Laser fluences exceeding 2.8J/cm2 caused a complete extinction of all living cells by a single laser impulse. Temperature rise within the implant is dependent on repetition frequency but overall negligible.
The effectiveness of biofilm removal after cleansing with Octenidine soaked gauze and irradiation with the Er:YAG laser will be evaluated on cultivated and extracted pins.
Conclusions We want to compare the effectiveness of the Er:YAG laser and Octenidine in the removal of biofilms from half-pins. We hypothesize that thee Er:YAG laser offers a secure, complete and non toxic removal of all kinds of pathogens from steel implants without damaging the implant or possible development of resistances. The precise non-contact removal of adjacent tissue could be an advantage over other disinfectants.
Level of Evidence (II-a)
Clinical Relevance:
Having one more arrow in the quiver for disinfection of percutaneous implants or for septic revision surgery when osteosynthesis equipment or arthroplasties are meant to be left in place would be extremely desirable.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- same as inclusion criteria
Key inclusion criteria (1 listed)
- All patients that are treated with external fixators for at least 2 weeks and patients whose implants have to be removed during septic revision surgery.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completeness of biofilm removal
Time frame: 2 years
Is the Er:YAG laser able to remova a microbial biofilm from cultivated or infected implants
1 secondary outcome
Side effects
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Devices Associated With Misadventures, Prosthetic and Other Implants, Materials and Accessory Devices, 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 21 Jul 2017. 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?
Contact Lukas K Kriechbaumer, MD (+43 (0) 5 7255 - 57156, lukikriechbaumer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness of biofilm removal (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2017.