Introduction

Short-segment posterior instrumentation for spine fractures is threatened by unacceptable failure rates. Two important design objectives of pedicle screws, bending and pullout strength, may conflict with each other.

Bone shape variability within a specific population has been seldom investigated and used to optimize implant design. There is insufficient anatomical fitting of the existing prebend periarticular plates for the distal fibula. We developed a methodology for design of orthopaedic implants that fit a maximum percentage of the target population, both in terms of geometry and biomechanical stability. In co-operation with an implant manufacturer and different academic institutions, a virtual bone database has been developed that contains anatomical data of more than 1000 CT datasets with the implemented possibility to generate idealized implant fits for different anatomical sites. This program (Stryker Virtual Bone Database (VBD) is able to generate statistical anatomical shapes for different populations like age groups or ethnical groups. Based on this, an implant for the distal fibula has been developed (VariAx Distal Lateral Fibula Locking Plate) for distal fibula fracture treatment. Aim of this study was to develop and validate an implant that is optimized for the specific anatomical area. It should be precontoured and still fit to the majority of patients sustaining a distal fibular fracture. Another objective was to create a distally tapered design as there is less soft tissue cover in that anatomic area.