Orthopedic Devices Associated With Misadventures, Prosthetic and Other Implants, Materials and Accessory Devices Clinical Trial
Official title:
Sterilizing Effects of the Erbium:YAG Laser Upon Metal Implants
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | October 1, 2017 |
| Est. primary completion date | September 1, 2017 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Austria | University Clinic of Traumatology, Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna | Paracelsus Medical University |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Completeness of biofilm removal | Is the Er:YAG laser able to remova a microbial biofilm from cultivated or infected implants | 2 years | |
| Secondary | 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 | 2 years |