OrthoXel Completes Clinical Study for Apex Tibial Nailing System

OrthoXel has completed clinical research on its Apex Tibial Nailing System. The company will present its findings on “Micromotion Nailing for Accelerated Fracture Healing” at the ORS ISFR 18th Biennial Meeting, in Montréal. 
 
Apex Tibial Nailing System produces controlled axial interfragmentary micromotion fixation to accelerate fracture healing and improve patient outcomes. Clinical evidence now shows faster time to union, higher callus rigidity, and significantly improved healing rates in high-risk patients. The Apex system offers a new approach to addressing the ongoing challenges of tibial shaft fractures
 
The clinical study was completed at Cork University Hospital in Ireland. It compared the Apex Tibial Nailing System with micromotion fixation to standard static locking methods.
 
Key results include:

• 18% Faster time to clinical union with micromotion.
• 26% Higher callus rigidity at 12 weeks for high-risk patients.
• 50% of Apex patients achieved union in under 13 weeks.
• Significantly more new bone formation in high-risk patients. 

A notable case from the study involved a 55-year-old male patient who sustained an open tibial fracture after being crushed between two vehicles. Despite extensive soft tissue damage and a high-risk injury classification, the patient achieved clinical union within 12 weeks using the Apex system, with robust callus formation and minimal complications.