On Tuesday April 27 the first clinical application of a new plate for proximal humeral fractures has been performed by R. Rotini, MD, in Rizzoli Orthopaedic Institute in Bologna, Italy. 

It has been a great satisfaction to attend surgery after approximately one year of thinking and adjusting both the design and the instrument set first release.It has been the first trauma application of a new polymer, CFR peek (30% carbon fiber reinforced peek). The new osteosynthesis device presents the following unique features which represents real clinical advantages:

1. the titanium alloy screw will ‘tap’ the hole, thus allowing polyaxial insertion
2. since the peek material used for the plate is inert, we do not have any galvanic corrosion between plate and screws, thus allowing an easier removal
3. since the peek material used for the plate is translucent, surgeons have a very easy post-op following of the healing processMechanical properties are:

• bending strength: approximately at 200 N/mm2, very close to stainless steel commonly used in osteosynthesis devices
• elastic modulus: equivalent to the cortical bone it is five times better than titanium alloyIn terms of biomechanical validation during almost one yearPRE-OPPOST-OPperiod of project development we have performed the following tests:
• four point bending static test: we obtained the plate breakage at more than 500 N, very safe considering the post-operative rehabilitation process
• four point bending fatigue test: it has been carried out through successive steps starting from 240N and enduring 250.000 cycles. Every 250.000 cycles the increase was of 20N. The breakage occurred at 380N, reaching a total of 1.750.000 cycles
• push out test: evidence of a very strong angular stability fixation between screw and plate, more than 1.400 N necessary to disassemble the system, once the screw has tapped the hole in the plate.

Here enclosed the pre-operative view of the displaced proximal fracture, the intra-operative reductions by using Kirschner wires and the translucent plate which allow perfect evaluation of the fracture’s rim congruency. The post- operative a-p and l-l projections enhance the plate’s unique features.

Even if these preliminary results should be confirmed by clinical evidence we are confident that the application of this new material could represent an important step forward in terms of product innovation in traumatologic surgery.