The bone fracture plate osteosynthesis has been used to treat femoral fractures for some time. These plates are designed for anatomical and stable fixation of the fractured femur, allowing to restore bone integrity and limb function. Because each of us is anatomically different, our femurs are different as well, therefore, the plates are made in different lengths, shapes and modifications. The standard femoral fracture treatment plates are non-active class IIb medical devices.
The market offers a great variety of femoral osteosynthesis plates of various modifications, however, breaking of a plate remains a common complication in clinical practice. The reasons for that can be different. For example, a patient puts weight on the injured leg too early, the plate was poorly fixed to the bone, the shape of the plate does not match the external surface anatomy of the femur – all of the above leads to inadequate distribution of force and increases the risk of breaking of the plate, subsequent bone structure, pain and inflammation.
In cooperation with the scientific partners (LSMU, VU), Ortho Baltic has developed the new generation femoral fracture treatment (osteosynthesis) implants. The femoral bone fracture treatment plates are complex medical implants manufactured in Lithuania and certified as IIb class devices. The EC certificate confirms that Ortho Baltic maintains the full product quality assurance system from the design of the product to the final product quality control.
The developed implant set comprises 6 models of osteosynthesis plates: four of which are for the proximal end of the femur, one for the femoral shaft and one for the distal end of the femur.
The surface of the plates manufactured by Ortho Baltic are better adapted to the bone surface topology of the Baltic region residents than other plates available on the market. The plate fits tightly to the bone, reduces bone fragment mobility in respect of the plate, and ensures better bone regeneration. The plate design was developed on the basis of the radiological computer-based angiography scanned images performed by the Hospital of Lithuanian University of Health Sciences Kaunas Clinics (Kaunas Regional Biomedical Research Ethics Committee permit No BE-2-62 of 2 December 2014). These scanned images were used to recreate 3D femur models, perform osteometric calculations and refine the femoral plate design. The plates are made of titanium alloy powder (Ti6Al4V) with application of the additive manufacturing technology – direct metal laser sintering (DMLS).
Application of these plates allows:
- To ensure maximum tightness of the plant against the greater trochanter of the femur (GSSPT01-GSSPT04), thus reducing the risk of complications;
- To ensure efficiency of osteosynthesis of different femoral proximal end fractures at two different plate proximal end opening configurations (GSSPT01-GSSPT04) adapted for certain types of fractures without compromising the mechanical properties of the plate;
- To reduce the probability of the secondary bone fracture due to the plate introduction, where the screw holes have not be positioned in a straight line.
The openings on the plate are oriented at a certain angle along the centre of the body of the femur to ensure entry of the screw through the thickest part of the bone. The plates presented allow to perform the osteosynthesis of the proximal end of the femur, while their structure is designed on the basis of careful anthropometric measurements of the population.
The femoral osteosynthesis plates have been developed in the course of implementation of the project No VP2-1.3-ŪM-02-K-04-112 “Development of the New Generation Orthopaedic Implants” and project No 03.2.1-LVPA-K-802-01-0050 “Certification of the New Generation Orthopaedic Implants,” partially funded under the EU Structural Fund aid.