Strathclyde project and student brief
Wound management and early prosthetic rehabilitation, a randomised clinical study utilising conventional and direct manufactured transtibial prosthetic systems in a primary patient cohort.
This scholarship is a collaboration between the University of Strathclyde, (biomedical engineering), Össur Clinics and Össur R&D.
The student on this project should have a background in biomedical engineering, tissue biomechanics, prosthetics & Orthotics, medicine or other related fields.
For the population who are affected by limb loss, the interface between the socket and residual limb is one of the most complex but important parts of a prosthetic system to realise the potential quality of life improvements of rehabilitation. This socket/body interface plays a fundamental role in the user’s comfort and control of the prosthesis to regain mobility. This is especially true for primary amputees where the soft tissue has not yet been conditioned for prosthetic use and the available alternatives in postoperative treatment and rehabilitation are often based on low quality evidence. Therefore, wound healing its management and soft tissue health in general, are essential to speed up the rehabilitation process and increase the outcome potential and is therefore the main driver for this proposal. We propose to contrast two clinically utilised but distinctly different socket concepts i.e the conventional PTB style socket and the pressure casted direct socket system.
Ongoing work in the research group and industrial Partner
The student will work in the mechanobiology group in the Department of Biomedical Engineering at the University of Strathclyde. In the past 5 years, the group has used a new approach to research and development of P&O solutions, investigating long-term musculoskeletal health while focusing on patients’ needs and the environment they live in. This approach ensures appropriate solutions and services promoting the physical performance, comfort, and health of lower limb prosthetic users. Recent advancements include the development of a range of lower limb prosthetic products appropriate for LMICs, the characterisation of functional outcomes for different prosthetic products, and the improvement of understanding of cellular and tissue response to a complex mechanical environment. The research group is also a member of the Vascular Surgeons interest network.
Ossur (ongoing work): The Direct Socket system is a system that has been developed since the 90´s. The current version came on the market 2019 and was a successor of a system called MSS that has been on the Scandinavian market since 2004. The main changes that were made was related to the working procedures and safety, material improvements and a TF version. The DS-TF version went through a clinical study in US,10, 11.
Although the student will be the custodian of this project, they will benefit from the presence of experienced postdoctoral researchers who have worked on several projects on P&O technology development in a variety of settings, with experienced clinical partners. The group also has developed a mechanobiology model in relation to deep tissue injury (DTI) and has an extensive experience in clinical studies in the UK and internationally. In addition, the industrial partner has developed treatment solutions for the rehabilitation of lower limb amputations with recommendations including residual limb conditioning and prosthetic provision. The industrial partner is committed to provide the monetary and clinical support required.
- Through a systematic literature review, establish a set of essential and desirable biomarkers including data capturing technologies to quantify wound healing and soft tissue health in an ageing population.
- Through experimental clinical studies with a cohort of primary amputees to validate the in the aim 1 identified biomarkers and related technologies.
- As part of the above studies, where standards do not exist, propose standard test methods, and establish validity, test-retest, etc. metrics for any clinical standard tests.
- With regular feedback from users, design and develop a robust clinical study protocol for primary amputees contrasting conventional and pressure casted socket designs.
- An indepth cost analysis of the 2 proposed different prosthetic design interventions