Post Marketing Clinical Follow-up Study, a single arm prospective case series to evaluate the safety and effectiveness of Intramedullary Tibia Nailing system intended for Tibia bone related fracture fixation (PMCF-INITIA NAIL)

The most common and major fractured bone in the leg is considered to be a tibia bone. The fracture can lead to long hospital stay and can affect the life of the patient socially, mentally and professionally as well. Because of many factors , these injuries are not easy to manage. These factors includes limited soft tissue cover, poor vascularity of the injured area. The most recognized complications includes infection, mal-union, and non-union (Achten et al., 2015). Intramedullary nailing is considered as the gold standard of care for tibia shaft fracture. This is so because it helps in the reduction of surgical insult to the fractured and soft tissue (Attal et al., 2012).The incidence of tibia fracture has been varied from years across different countries and culture. One study has concluded that males have highest rate of incidence which is recorded as 21.5/1000000/year when compared with the rate of women. The highest frequency of fractures lies between the age of 10-20 years (Larsen et al., 2015). According to AO classification, the most common type of fracture recorded was type 42-A1 which constitutes of 34% of total tibial shaft fracture (Larsen et al., 2015).

There are many techniques which are used for the operative management of the fractures. These techniques includes intra-medullary implants, half-pin external fixation, hybrid thin-wire external fixation, and plate fixation. In recent years, intramedullary nailing technique is widely used for  proximal and distal tibial metaphyseal fracture (Meena et al., 2015). Out of these techniques, most widely used are minimally invasive Plating and Intramedullary Nailing technique.

Intramedullary Nailing provides better functional outcomes and provides required mechanical stability and better fracture alignment. Intramedullary tibia nails can be implant via different approached including reamed & unreamed, compression and non compressive and locking options include static, dynamic and dynamic compression (Duygun, 2018).

In this post-marketing clinical follow-up study, the safety and effectiveness of intramedullary nailing system, which is intended for Tibia bone related fracture would be studied.