The Biostat Research and Development Center will conduct a multicenter, open-label clinical trial aimed at evaluating the safety and efficacy of the Orthoget hybrid intramedullary nail system.

The study will compare the Orthoget hybrid intramedullary nail system with the PRECICE® intramedullary nail for the treatment of adult patients with lower limb length discrepancies or for femoral lengthening in aesthetic surgery.

Biostat will be responsible for the comprehensive management of the trial.

Our responsibilities include, among others: project management, preparation of electronic medical documentation (eCRF), monitoring of the trial, preparation and compilation of required documentation, administrative support (including contracts with centers), management of the electronic document repository (eTMF), and handling of data collected during the trial,”

Orthoget is a bioengineering company that, since 2017, has been conducting intensive research and development on modern solutions for the treatment of lower limb asymmetry. The company focuses on the design and implementation of a technologically advanced implant — the OrthoNail Hybrid Intramedullary Nail — which, thanks to its magneto-mechanical drive, aims to streamline the process of long bone lengthening. This solution has the potential to significantly improve the quality of life for patients with congenital, post-traumatic, or dwarfism-related deformities and may also find application in aesthetic medicine.

Read more about clinical trials conducted by Biostat.