Conclusions and Results of Study

In summary the recently completed clinical study examined how the Apex Tibial Nailing System with micromotion fixation compares to the current standard of care (static locking) for treatment of tibial shaft fractures. This study reported:

• Healing speed (time to clinical union)
• Incidence of complications including delayed healing and nonunion
• Early mechanical integrity of new bone

The study showed superior results with Apex micromotion across all key clinical outcomes measures. There were zero nonunions in any micromotion patient, versus 11% nonunion in the control group. Micromotion patients also healed faster than static locking patients, resulting in fewer delayed unions.

CT scan analysis showed that micromotion substantially increased bone formation in patients who had increased risk for problems in bone healing due to health comorbidities like smoking and diabetes.

Overall, the pilot study suggests that Apex micromotion nailing has potential to decrease the clinical incidence of delayed healing and nonunion and increase the speed of healing for all patients.

Read the study article published in Bone & Joint Open Journal.

Read Clinical Whitepaper

In this case series of four high-risk tibial fractures treated with the Apex Tibial Nailing system, all four patients demonstrated outstanding healing results.

Case example 

Case D (Figure 5): Male, age 55, crushed between two vehicles and sustained an open (Gustilo-Anderson IIIB) tibial fracture, OTA/AO 42-C3. Soft tissue injury was extensive with degloving and muscle loss, but no arterial damage. Primary fixation by reamed nailing was undertaken with debridement and flap coverage by a plastic surgery team. RUST scores at 6 and 12 weeks were 8 and 12. Proliferative callus
was observed on the 12-week CT scan and the limb had achieved a normalized virtual torsional rigidity, VTR = 0.87 (fractured/intact), which indicates that surprisingly advanced structural healing had already taken place, given the severity of the soft tissue injury.

Clinical union was achieved by 12 weeks and the patient continued with no sign of infection, no additional procedures, and good functional recovery with minimal pain. Given the high energy injury in combination with the degree of communication and soft tissue loss, to achieve robust callus bridging at 12 weeks is an exemplary healing result.