Defining the clinical problem
In 2016, the aesculapian members of the INEG thoroughly reviewed the clinical performance of the Expert Tibial Nail System ( available since 2005 ) to identify the most authoritative aspects that had to be addressed by a adjacent genesis tibial nail down system for better patient worry. Review findings were supported by discussions at our AO TC Trauma Experts ‘ Symposia, verified by publish literature, and confirmed by field studies equally well as surgeon interviews performed by DePuy Synthes ( DPS ) .
The follow outcome-related problems were identified for tibial fracture discussion :
Delayed union, nonunion, and malunion
Intramedullary smash ( IMN ) is the most popular and widely used method for treating tibial cheat fractures. From a biomechanical position, the nail is a cardinal, load-sharing implant which provides high constancy to support early on postoperative affected role mobilization. This device specific benefit, in concert with the advantage of the soft-tissue sparing instrumentation, guided surgeons to expand their pinpoint indications into the metaphyseal zones of the tibia. While plate obsession is decreasing, IMN is becoming increasingly popular for proximal and specially distal tibial fracture arrested development.

Expanding the nail down indications toward metaphyseal tibial fractures results in the challenge to fix short bone fragments with adequate stability to promote bone healing and to avoid secondary loss of reduction. This challenge is pronounced in belittled bone quality, the happening of which is increasing because of the aging population. A multicenter cogitation with the Expert Tibial Nail from DPS revealed a 12.2 % rate of delayed union at 1 class [1]. A nonunion rate of 12 % was reported for ream IMN in a single-center study with 1003 patients [2]. A systematic review and metaanalysis of IMN versus minimally invasive plate osteosynthesis for distal tibial fractures resulted in a 14.8 % malunion rate for nailing which was significantly higher than the 8 % malunion rate for plating [3]. All these numbers emphasize the importance to increase the arrested development stability provided by IMN to avoid complications and to reduce the reoperation rate .
Patient pain and discomfort
In a holocene retrospective experimental study, [4] 27 % of 126 patients treated with a tibial collar reported pain attributed to locking screws at follow-up. Interlocking screw prominence is a frequent argue for soft-tissue irritations which may require fuck removal in a secondary intervention. Contributing factors for soft-tissue irritations are bad soft-tissue coverage ( particularly around the distal tibia and in aged patients ), imprecise sleep together distance measurement, and the size/design of the engagement sleep together question and tip.

There are far procedure-related aspects that had to be addressed in the growth of a new state-of-the-art tibial complete system :

Anatomical nail fit
It is all-important that the collar design is optimized to fit most of the anatomic variations of the tibial canal. Adequate smash fit is substantive to facilitate implant placement and to avoid deformities or iatrogenic fractures due to nail insertion. so far, surgeons have used the cannulate Expert Tibial Nail which has been provided in two different breeze through purpose versions : ( 1 ) nail with 10.5° flex starting at 75 mm proximally with a radius of 376 mm to 1128 millimeter depending on the nail length ; ( 2 ) nail with 10.5° bend starting at 65 mm proximally with a fixed radius of 100 mm and a 3° point crouch starting at 57 mm distally ( called ‘Expert Tibial Nail with Proximal Bend ‘ ). The latter has been used more frequently, particularly for the treatment of proximal tibial fractures. During the development of a adjacent generation tibial nail the succeed questions had to be addressed : ( 1 ) Is there a more optimum nail plan ? ( 2 ) Is one nail invention sufficient or is it required to offer two unlike smash designs with the built-in portfolio complexity ?
Usability aspects
Implant systems should be slowly and intuitive to use and to support reproducible outcomes by reproducible instrumentation. Surgeon feedback is that some orchestration steps of the Expert Tibial Nail are perceived as complex. Angular stable lock in of the Expert Tibial Nail with the Angular Stable Locking System ( ASLS, launched in 2010 ) is an exemplar. This system requires dedicated ASLS screws, bioresorbable ASLS sleeves, and special instruments to achieve angular stable connections between the locking screws and the nail. The procedural complexity of ASLS contributed to the clinical demand for an easier angular stable locking solution .
Instrumentation for different surgical approaches
The infrapatellar approach in a flex knee position is regarded as the standard approach for IMN of tibial fractures. however, approaches for semi-extended knee position are quickly gaining popularity : intraarticular suprapatellar access and extraarticular parapatellar approach path. They can improve the surgeon ‘s ability to obtain, maintain, and with trope intensification evaluate fracture reduction, particularly in proximal and distal tibial fractures [5]. besides, the semi-extended knee stead requires less patient manipulation and eases image intensification during the surgical procedure.

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