SAFE DualCore Universal Nail. Interlocking Nail with a long lasting PMMA cement with antibiotic releasing core.

Craveiro Lopes N, Escalda C and Leo M Orthopedic Department, Garcia de Orta Hospital Almada, Portugal

We have conducted a experimental and clinical pilot study on a modified Grosse nail with transfixing holes along both sides and filled with PMMA cement with antibiotics, with the intension of develop a fixation device adapted to be used in cases of bone fracture or fragility with high risk of infection. This pilot nail proved to be 10% more resistant than the original Grosse nail and releases antibiotics in 6 to 12 folds the MIC during more than 12 months, characteristics suitable but insufficient for some of the cases with late consolidationvery common in our practice... ,

So we constructed a stronger nail and developed a new technology, named DualCore, to get more resistance to fatigue and opened more releasing holes that can be used to fix intermediary fragments, using two antibiotics in higher concentration, to permit a better local elution. We call this new device, SAFE DualCore Universal Nail.

This new nail was tested in laboratory. Without the double core, this new nail shows 100% more resistance than the Grosse nail and with the DualCore Technology, it is 220% more resistant than the standard Grosse nail.

With regard to the antibiotic elution values, we can see with the brown line the pattern of release from a cylinder of cement and of the modified Grosse nail (red line), both with one gram of vancomicin, with an average level of release of 8 micrograms per milliliter ... While the new nail with more releasing holes and 2 grams of vancomicin releases an average concentration of

antibiotics of more than 14 micrograms per milliliter.

So, the advantages of this newbiologically active nail include a better resistance, more than the triple of the standard Grosse nail, adapted to cases of late consolidation ... And a local antibiotic elution in concentrations 14 folds the minimum inhibitory concentration during the time of implantation of the nail, allowing an effective suppressive therapy.

The preparation of the SAFE nail is a 10 minute procedure and includes the wrapping of the nail with a Esmach band and the injection of a misture of apropriate antibiotics inside the nail using a cement gun.

From June 2011 to July 2012, we used this nail in 11 cases, including one case of open fractures, one conversion from external fixation on a open fracture, four cases of lengthening with external fixation then nailling, two cases of knee artrodesis with external fixation then nailling, one case of ankle artrodesis with nail, one case of osteomyelities after nailling and a case of fracture in cronic osteomyelitic bone. Bacteriological examination was made of exudate in 9 of eleven cases praior to the nailling, revealing clinically aggressive bacteria in 9 cases, predominantly the methicillin sensitive Staphylococcus wich appeared in 65% of patients . Clinical cases

This patient had a grade II open fracture and was nailled immediately. can observe the perfect fit We of the nail to the shape of the tibia in the profile.

The patient at six weeks of follow up begun to do total weight bearing and returned to work as a karate teacher.

This second patient had a sequelae of an infected total knee replacement. After 10 operations, we proceeded to a knee arthrodesis and tibial lengthening with a Ilizarov apparatus. Three months after we have done a conversion to a SAFE DualCore Universal extra-long nail, reinforced only in the area of the knee and tibial lengthening, leaving some flexibility in the proximal femur.

This was an achondroplasic patient that was subjected to a lengthening with a monolateral distractor over a kirshnner rod and the result at 3 months of follow up after the conversion to a SAFE DualCore nail, with consolidation, without infection. This 21 years old patient with a sequela of high riding Congenital Dislocation of the Hip subjected

to a hip reconstruction with Ilizarov, frame was infected with a Staphilococus. We have done a conversion to a SAFE nailand two months after the patient had a fall and broke the femur above the nail.

We exchange the SAFE nail with a longer one. At two months of follow up there are no infection present and consolidation is on the way.

This forty three years old female had a 4 cm femoral shortening after a fracture and was subjectet to a lengthening with a Ilizarov frame. After the distraction period at the end of two months she was infected with a Staphilococus Aureus.

We then made a conversion to a SAFE DualCore nail. Thee result at the end of two and a half months with consolidation without infection.

A twenty four years old man was run over by a car with open fractures of both legs, was operated with standard interlocking nails. One month after a fistulae apeared on the right leg and bacteriology revealed a Enterobacter Cloacae infection.We removed the nail, cleaned the medulary canal with the RIA system and introduced a SAFE DualCore Universal Nail with Meropenem and Vancomicin, antibiotics guided by the sensibility tests. The control at one month after surgery with cure of the infection and patient doing full weight bearing.

Finally this thirty two years old man presenting an ankle arthrosis after a open fracture with infection whenhewas17yearsold,withaequinusandsuppinatusfoot

He was subjected to an ankle arthrodesis with a SAFE DualCore Universal nail. The control at 2 moths of follow up with consolidation in a good position.

According to the classification of Paley, in all the treated cases, we had 2 obstacles, including a fracture above the nail solved by a longer nail and a malrotation solved by correction with exchange of distal screws.We had no complications, namelly infections or nail failure.

The conclusions of this preliminary report are very encouraging. We found the procedure simple and fast to perform, the nail is more resistant than the original one, more than three times, It is possible to interlock intermediary fragments, there are a possibility to chose the right antibiotiand with 2 c grams of antibiotics, the release is more than 14 folds the MIC throughout the time of implantation of the nail, we found that the reaming procedure and the stability of the nail leads to a faster consolidation. The preliminary clinical results are excellent, with no infection, with less time of hospitalization and treatment costs.