BACKGROUND

Orthopaedic fractures are a common daily acute health issue.
A significant increase of bone fracture cases is expected in the
coming years as a result of:

Population aging (Figure 2) and increased life expectancy with osteoporosis – the most common
cause of fractures –
epidemiology facing worrisome outlooks that foresee the increase of hip fractures to increase over 200% in the next 30 years .

More active lifestyle.

AdvicePic Road traffic accidents (RTAs) and sport injuries.
According to the World Health Organization, RTAs result in about 25.4 million severe injuries per year worldwide. RTAs are
projected to become the third leading cause of disability-adjusted life (DALYs) worldwide by 2020 . Moreover, those injuries
are an important source of direct medical cost as well as indirect cost resulting from economic production losses, overtime
and administration costs. The direct medical care costs of all hospital treated injuries (inpatients and outpatients) in the EU
is estimated to be at least 78 billion Euro each year. The indirect costs can be as much as twice higher than the direct ones .
The situation is even more dramatic in emerging countries where trauma injuries are expected to.


PROBLEM

Fractured bone injuries are normally treated by deploying different fixation implants to patients, as well as internal or external
trauma fixation devices. The internal trauma fixation devices (Figure 3) are more widely used, accounting for 87.7% the overall
trauma fixation devices market share in 2014 .
Most standard metal internal fixators need to be removed after the fracture has healed.
This needs open surgery under full
anaesthesia, which is both costly and potentially dangerous.
The global trauma fixation devices market is expected to grow at
a
compound annual growth rate of 6.9 % in the period 2014-2019 and to reach € 8 billion by 20208.

In 2008, fixation devices were used in approximately 420.000 surgeries in Europe, associated with
direct costs of more than
€4.8 billion . A significant portion of these costs (15%, €720 million) result
from re-interventions needed because of failed
surgical technique, usually caused by errors in the
treatment of the fracture due to the low performance of the implants.

Renowned fixator manufacturers have been forced to perform product recalls (see Table 9).


CURRENT ALTERNATIVES

The different alternatives available in the market are assessed from two different perspectives: the clients (doctors, hospitals) and
the end users (the patients).
AdvicePicCLIENTS: hospitals, healthcare providers, medical doctors
MATERIAL: plastic, or metal devices made of Titanium alloys or Stainless Steel
Currently used trauma metal nail implants are designed with pre-drilled holes nail to be interlocked with screws to the broken
bone with the aid of several sophisticated X-ray imaging in the operation room (Figure 4). The holes and their angle are pre-fixed
leaving little or no room for manipulation.

Cut-out (antero-posterior deviation) phenomena of the metal screw in the hole breaking the bone before final healing as a result of difference in material characteristics of metal compared to bone (hardness). The elastic modulus of Titanium alloys and of stainless
steel is around 30 times higher than that of the bone (120 GPa and 180 GPa for Titanium alloys and steel, respectively
compared to 12 GPa for the bone).

CT and MRI dispersion of metal nails lead to visual difficulties and require repeated imaging during follow up.

In case of plates: the design is such that the plates have many holes for various options of locating the screws. Such design weakens the plate.

Require long exposure to repeating X-ray imaging systems at least 3-5 (up to 10) times in order to locate the placement of
interlocking screws in the metal nail.

Metal promotes bone lysis (Periprosthetic Osteolysis) due to release of tiny sub-microns size debris into the human cells and surrounding soft tissues. The body reacts by releasing agents (macrophages) that attack the bone implant interface causing
loosening, infection and sometimes poisoning.

 


This Project has received funding from the European´s Union Horizon 2020 research and innovation programme under grant agreement No 767901.