CiproScrew™
The world’s first fixation device with long term drug delivery.
There are several factors that may increase the risk of implant related infections in patients undergoing surgery. Such factors are e.g. smoking, diabetes, high age and open contaminated fractures for example in case of trauma. On average a few percent of initially inserted fixation devices become contaminated and cause bacterial infection. Nevertheless, in case of open fracture the incidence of infection is reported to be as high as 30%. The treatment of implant-related infections is very challenging, long-lasting and expensive. Most common treatments include long term antibiotic medication and removal of all foreign bodies. By introducing the world`s first antibiotic releasing bioabsorbable screw – CiproScrew™ Bioretec offers solution to prevent implant related infection.
Figure 1. Bacterial culture (S. aureus) on a Petri-dish with a metallic screw on the left (A) and CiproScrew™ on the right (B) after 18 hours incubation at 35°C. The antibiotic effect on the S. aureus culture can easily be seen as a clear ring around the CiproScrew™.
In preclinical[1.] and clinical investigations serum concentrations of ciprofloxacin remained undetectable. In animal studies CiproScrew™ has shown local ciprofloxacin release around the implant, 100% prevention of implant-related infection and good biocompatibility.
These observations suggest, that the use of CiproScrew™ may reduce the number of implant related surgical site infections (SSI`s). CiproScrew™ enables the local release of ciprofloxacin and thus prevents inhibition of ciprofloxacin sensitive organisms to attach the surface of the screw.
CiproScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures in the presence of appropriate immobilization when infection by ciprofloxacin sensitive organism is a potential risk.
Properly used, in the presence of adequate immobilization, CiproScrew™ maintains accurate alignment of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot after surgical procedure. As the operated bone fracture or osteotomy gains strength during healing, the CiproScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. In clinical investigation CiproScrew™ showed equal healing results (tai clinical outcome and safety profile) as metallic standard screw used in ankle syndesmosis fixation.
Figure 2. Release profile of ciprofloxacin from the CiproScrew implant in vitro. The drug is released from the CiproScrew™ within 30-36 weeks.
The drug is released from the CiproScrew™ within 30-36 weeks. Bioabsorption of the CiproScrew™ implant takes place approximately within two years thus eliminating the need for implant removal surgery. CiproScrew™ is delivered inside the CiproScrew™ holder. This is made for protection of the screw during storage/delivery, and for easy and aseptic implantation of the screw.
Similar design to ActivaScrew™
CiproScrew™ has the similar design to ActivaScrew™ offering new solutions and advantages unlike metal screws or other bioabsorbable screws.
CiproScrew™ has high strength and mechanical properties, it is easy to use and compatible with the AO instrumentation that is a great advantage for hospitals.
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Inhibition of ciprofloxacin sensitive organisms to attach the surface of the screw
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An adequate range of fully threaded and partially threaded screws
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High usability for various indication
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Compatibility with AO-instrumentation
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Auto-Compression™, reduces the risk of unstable fixation
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Isoelasticity; the bending modulus is closer to the value of cortical bone compared to metallic implants
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High strength properties offer easy insertion and safe medical use.
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No stress shielding
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No need for removal operation
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Bioabsorbable implants transfer gradually stresses to the bone, thus reducing potential stress shielding.
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Implant is supplied Gamma sterilized – safe, free of gas remnants, reduced cross infection risk.
Manufacturing process of CiproScrew™ generates the high initial mechanical strength and stiffness of the screws. Properly used, in the presence of adequate immobilization, CiproScrew™ maintains accurate alignment of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures after surgical procedure.
[1.] (Sanna-Mari Niemelä, 2004, Mäkinen, et al., Bone 2005; 36: 292-299, Tiainen, et al., J Mater Sci: Mater Med 2006; 17: 1315-1322)