Apex Micromotion Clinical Study Design

A 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:

1. Healing Speed (time to clinical union)
2. Incidence of complications including delayed healing and nonunion
3. Early mechanical integrity of new bone

Patients in the micromotion group had Apex Tibial Nails. These implants generate beneficial passive motion during the early healing period while a patient goes about their normal activities of daily living. The Apex Tibial Nail has the following design features:

• Controlled axial micromotion is enabled by a gliding insert in the proximal end of the nail stem. This design provides 1 mm of axial motion to mechanically stimulate bone growth.
• Best-in-class torsional stability is created by the insert design, which prevents rotation of the bone fragments. and is the first and only micromotion-enabled IM nailing system designed to stimulate bone healing
  Insert micromotion locking image.

The Apex micromotion was compared to a control group treated with conventional intramedullary nails in standard-of-care static locking mode. Static locking means that the implant does not generate passive micromotion.

Patients in this study were enrolled at the time of their surgery and followed for one year. All cases were completed in a single Level I trauma center by multiple surgeons. Cases included a wide range of fracture types, including open and closed injuries and a mixture of high- and low-energy injuries.

CONCLUSIONS AND RESULTS OF STUDY >