MEDICAL IMAGES AND LOADING DATA COLLECTION ON PATIENTS
Research type
Research Study
Full title
LOADING + KINEMATIC DATA COLLECTION FROM ITAP (Intraosseous Transcutaneous Amputation Prosthesis) AND CONVENTIONAL AMPUTATION PATIENTS FOR NUMERICAL MODELING USING PATIENT MEDICAL IMAGES.
IRAS ID
226799
Contact name
Catherine Pendegrass
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
20 intraosseous transcutaneous amputation prostheses (ITAP) were surgically implanted into the amputated leg of patients participating in a clinical trial at the Royal National Orthopaedic Hospital, Stanmore between 2008-2013.
There were 2 types of ITAP fixation used; cemented and pressfit. In about 1/3 of the patients cement had to be used due to them only having very thin cortical bone. The remainder had enough bone stock to not have to use cement; and in these patient’s a process called osseointegration occurred where bone grows onto the implant and provides added stability and bone stock. If a new ITAP design could reduce cemented fixation, then loosening of the implant (aseptic loosening) could be reduced.
A method will be developed where patient bone architecture can be computer modeled and stresses subsequently managed through changes to the implant. This will allow the ITAP design to be changed such that fixation techniques can be achieved without cement in patients even with very thin cortical bone.
If a new ITAP design could increase the ability to fixate to a very short femoral bone (residuum) then the number of amputees who could be offered an ITAP solution in future could increase. This is because the current design can only be offered to patients with mid-thigh (or longer) residuum.
Loading data, which is not currently available, will be collected so that a range of forces can be applied to the implant to design ITAP solutions to manage and optimise stress in bone. For example, by changing the material properties and/or geometry of the implant. By understanding the stress distribution and the drivers that optimise bone strain then the most appropriate implant designs could be used to enhance implant fixation. This will result in less aseptic loosening and more patient’s being eligible for a better ITAP solution.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1508
Date of REC Opinion
9 Oct 2017
REC opinion
Further Information Favourable Opinion