CORK, Ireland, March 6, 2019 /PRNewswire/ -- OrthoXel is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXel is excited to announce the release of a new white paper showing early healing in high-risk fractures following the use of the Apex Tibial Nailing System micromotion locking option. The Apex Tibial Nailing System has United States FDA 510k clearance and is CE marked for Europe.
This new clinical white paper highlights four exciting, difficult surgical case reports of patients who were considered high-risk for compromised fracture healing based on their injury characteristics or comorbidities and who achieved successful, uncomplicated clinical union following the use of the Apex Tibial Nailing System utilizing the micromotion locking mode to promote bony callus formation.
Nonunion is a well-known complication that can occur in 7-19% of all tibial fractures treated in Level I Trauma Centers. Patients who experience compromised bone healing may require multiple surgeries over a prolonged period of healing. It is also associated with significant cost of care burdens, both for the healthcare system and the patients themselves. Known risk factors include open fractures, smoking, and systemic comorbidities.
In these featured cases extracted from an ongoing observational study of tibial fracture healing following Apex micromotion fixation, high-risk patients achieved clinical union quickly and with full return to mobility, despite having injury patterns and comorbidities known to increase the risk of nonunion.
Prof James Harty Consultant Orthopaedic Surgeon, Cork University Hospital, Ireland (Level I Trauma Center) – "This white paper is really interesting given the results I have seen in these challenging surgical cases. 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."
Hannah Dailey Co-Founder & Chief Scientific Officer, OrthoXel – "In this observational study, we are leveraging some exciting new imaging techniques to view 3D models of each injury at 12 weeks after surgery and virtually assess the mechanical properties of the newly formed bone. This innovative analysis technique has been recently published in leading journals and provides extraordinary quantitative and unbiased insight into the healing process."
Founded in 2014, and partially funded under the Enterprise Ireland, High Potential Start-Up (HPSU) fund. OrthoXel is a specialist orthopaedic trauma device company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXel is committed to patient-focused fracture care, offering surgeon-designed devices and an innovative approach to clinical evaluation, from initial concept designs through to full product launch.
For more information about the technical specification and advanced locking options of the Apex Tibial Nailing System and to download the white paper visit: https://www.orthoxel.com/wp-content/uploads/2019/03/CK-ADM-ML-005-Rev-1-Early-Healing-in-High-Risk-Fractures-Following-Apex-Micromotion-Fixation.pdf
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