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OrthoXel, an orthopedic trauma device company, has announced the release of a white paper publication that demonstrates early healing in high-risk fractures with the use of their Apex Tibial Nailing System micromotion locking option. The Apex system has already been granted FDA 510k clearance in the United States and is CE marked in Europe.
The publication analyzes four complex surgical case reports of patients at high-risk for compromised fracture healing due to the characteristics of their injury or any comorbidities.
Nonunion, a common complication in such fractures, can be observed in 7-19% of all cases treated in Level I Trauma Centers. Compromised bone healing can often require multiple surgeries to fix over a prolonged healing time, which raises the cost of care for both the institution and the patient.
The patients denoted in this publication achieved successful, uncomplicated clinical union after using the Apex Tibial Nailing System with its micromotion locking mode, leading to bony callus formation.
“This white paper is really interesting given the results I have seen in these challenging surgical cases,” states Prof James Harty Consultant Orthopedic Surgeon, Cork University Hospital. “I am looking forward to OrthoXel releasing the full results of this study later in 2019 showing results across all fracture and patient types not only high-risk patients highlighted here. The Apex Tibial Nailing system in micromotion mode has proven itself so far with these high-risk fracture patients, all of whom showed outstanding healing results.”
Orthopedic trauma device market research published by iData Research notes that intramedullary nails such as the Apex system tend to be more minimally invasive than orthopedic plates and screws as the incision required to place an intramedullary nail is small, at the end of the long bone. The tibial intramedullary nail segment is currently exhibiting modest growth in the United States. As the total population continues to age and require further orthopedic procedures, the intramedullary nail market is expected to have a sufficient patient base to continue its stable growth over the forecast period.
These featured cases are examples from an ongoing study on tibial fracture healing with Apex micromotion fixation where patients achieved clinical union despite having injury characteristics and comorbidities that commonly increase the risk of nonunion.
For Further Information
More on the orthopedic trauma market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Trauma Devices 2017 – MedSuite