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A self-driven intramedullary nail for the reconstruction of large bone defects

Lead Research Organisation: Imperial College London
Department Name: Bioengineering

Abstract

This project aims to evaluate a self-driven bone transport nail developed to reconstruct large bone defects caused by trauma, deformity, or cancer. Bone transport is an intervention whereby new bone is grown in a long bone where there is a missing section. It requires the division of the intact portion of the bone leaving a segment of bone that can be transported from its location in a controlled manner using either an intramedullary nail or an external ring fixation. External fixation is the preferred technique in the UK due to lower cost and lack of availability of other options that has a number of significant limitations, which are: prolonged treatment time, diligent care, as well as psychological, hygiene, and daily activity burden for patients and caregivers. Intramedullary bone transport methods also have a number of limitations that include: the daily involvement of patients during the distraction process; regular interventions by surgeons; and the significant cost of the procedure. These limitations have led to limited use of this method regardless of its superior outcomes compared to the external fixator method.

Addressing these limitations is the subject of this project: automating the process and significantly reducing its cost can considerably promote the use of nails in the UK as the primary technique for bone transport. In this project, we will experimentally demonstrate the feasibility and accuracy of the nail using an in vivo study on sheep. We will also engage with patient groups at the Royal National Orthopaedic Hospital during the study. This is to ensure it is well accepted and can be rapidly included in the current treatment pathway within the NHS once the clinical trials have been completed.

Publications

10 25 50
 
Description Gordon Blunn 
Organisation Royal Veterinary College (RVC)
Country United Kingdom 
Sector Academic/University 
PI Contribution We led the project.
Collaborator Contribution Intellectual contribution
Impact multi-disciplinary (materials science, orthopaedic science, veterinary science)
Start Year 2024
 
Title Bone transport nail to reconstruct segmental bone defects 
Description The medical product is a self-driven intramedullary nail for reconstructing large bone defects. Key features of the device include: - Designed to automatically drive bone transport without requiring patient involvement - Uses a hydraulic mechanism powered by a custom compression spring - Aims to be low-cost and load-bearing, suitable for both adults and paediatrics - Intended to allow patients to complete treatment with minimal disruption to daily activities The current stage of development is a prototype that has undergone preliminary testing. Specifically: - A prototype for an in vivo study has been developed and tested to demonstrate the feasibility of the self-driven distraction mechanism - Mechanical testing on stainless steel nails has shown the nail can withstand a compressive force of 11.8 kN, a torque of 14.4 Nm and a peak bending force of 2580 N - The distraction rate can be adjusted by using different biocompatible silicon oils - Once the desirable distraction is achieved, the in vivo will be performed in the near future The most recent principal source of development funding has been the MRC early-stage development of new healthcare interventions, which enabled us to de-risk the technology and manufacturing aspects significantly. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2024
Development Status Under active development/distribution
Impact N/A