RF-EOI-24-004
Amotio Personalised Bone Cement Revision Solution
Layperson summary
Up to 10% of hip, knee and shoulder prosthesis need to be replaced or revised annually. The surgical procedure to replace a prosthesis fixated within bone cement presents significant surgical challenges, can be traumatic for patients, represents high pathway cost and delays mobilisation and rehabilitation.
This orthopaedic solution is developed by a team of revision surgeons at University Medical Centre Utrecht. Amotio has been established to accelerate the development from concept to market launch. This disruptive innovation is a patient specific solution which rapidly dissects bone cement within the bone canal enabling swift, atraumatic extraction. It aims to reduce the risks and incidence of intraoperative fractures, cortical protrusion and major blood loss. It reduces the need to split open or cut a window in the bone.
This innovative solution will free up surgical capacity, reduce length of inpatient stay, enable immediate weight bearing, rapid mobilisation, improve outcomes and reduce costs.
Aim of your proposed research
This research aims to develop and evaluate the product in readiness for its first cadaveric evaluation. This requires the implementation of a robust, audited, iterative product development process, in conjunction with laboratory and simulated testing and evaluation.
This process includes the development of accurate processes for patient specific bone cement mapping, accurate and repeatable integration of personalised cutting guide channels, accurate additive 3D printing of the cutting and guide and development of a precise surgical cutting instrument (burr).
Clinical needs and risk analysis will be undertaken to ensure surgical usability and ensure robust device validation and verification.
Your research methodology
A product prototype and proof of concept has been achieved. The next stage delivers a compliant, audited, robust research programme comprising of iterative medical device development, leading to cadaveric evaluation, clinical evaluation and achieving regulatory approval with an experienced, dedicated inhouse team.
The research development plan will be delivered in collaboration with an experienced faculty of surgeons and researchers with our collaborative partners.
The research methodology comprises 5 core stages and 10 packages of work. The five key stages are:
Project Planning and management
Design and user needs inputs
System design and development
Medical imaging and DiCom modelling
System validation
Impact of your proposed research
This research delivers significant benefit to the patient, the surgical procedure and the patient pathway.
It will;
Enable patients to weight bear and mobilise rapidly after surgery and better aligned with elective arthroplasty outcomes
Significantly reduce surgical time by 90-120minutes
Reduce intraoperative blood loss from 1500mls
Reduce hospital length of stay to 3 days from 5-20 days
Reduce pathway and procedure costs of circa £10,000 per patient
This research will support the accelerated ability to achieve regulatory approval and launch this disruptive solution by 2027 enabling the solution to have a positive impact on overstretched clinical and system resources.
Are you a start-up?
Yes
Research activity area follow definitions provided in UKCRC Health Research Analysis 2022
Treatment Development
Amount requested (£)
£100,000
Duration (months)
12 months
Start date
06-01-2025
Is there an external research partner?
Yes
If yes, please specify
Collaboration with Hywel Dda University Health Board, Swansea University, Utrecht University, University Medical Centre Utrecht
Is there an Intellectual Property (IP) linked to this research?
Yes
If so, who owns and maintains this patent?
IP owned by the lead surgeon inventors with Utrecht University, with exclusive global licence provided to Amotio
Will you be testing on animals?
No
Have you previously received funding from ORUK?
No