Title: IL-KNEE II - delivery of a novel knee replacement
Funder: Department of Health (England)

Abstract: The proposed research will involve finite element (FE) modelling, design optimisation, mechanical and kinematic testing, and cadaver trials. The aim of this project will be met by achieving the following key milestones: Optimise the amount and location of resected bone from the tibia and associated implant geometry. Optimise the tibial component geometry and keel. Develop an instrument set for the implantation, with emphasis on the placement and fixation of the synthetic ligament. Assess the mechanical integrity of the device with bespoke testing. Evaluate the kinematics of the device in cadaveric knees. Assess the implantation procedure with cadaver laboratories. Milestone 1: A previous study showed that the resected bone around the ligament attachment in the proximal tibia considerably affects the mechanical integrity of the bone. A FE model will be generated that evaluates the mechanical environment in the tibia such that an optimal geometry can be found. An existing validated FE model will be used. The output of the FE model will be used to drive the design optimisation of the tibial tray geometry and keel. A CT database will be used to develop the geometry of the tibial tray. Milestone 2: Separate bone resection will be required either side of the ACL and PCL attachment points on the tibia and femur. Bespoke instrumentation will be developed that enable accurate bone resection without damaging the ligaments and enables accurate and reproducible placement of the synthetic ligament. Instrumentation will also be developed to ensure the flexion-extension gap is restored with the knee implant in-situ . CT data will be used to establish a jig that enables accurate positioning of the tibial and femoral tunnels so that the synthetic ligament can be positioned at the attachment site of the native ACL. A surgical protocol will be developed with the surgical team. Milestone 3: FE models will be generated to assess the mechanical integrity of the novel knee replacement tibial component. The FE models will assess simple mechanical testing in addition to clinically relevant bespoke testing. The output of this testing will feed into Milestone 1, and the components will be manufactured. Mechanical testing will be performed to assess the mechanical integrity of the components. Milestone 4: The novel TKR will be manufactured and implanted into cadaveric knees. Two cadaver sessions (12 knees in each session) will be used to assess the implants and instrumentation. Data from the first session will be used to further optimise the implants and instrumentation. The kinematics for the ‘native knee’ and implanted knees will be evaluated using state-of-the-art facilities at Imperial College London. The placement of the synthetic ligament will be evaluated. Milestone 5: Final manufactured prototypes will be implanted into cadavers to assess the surgical procedure and instrumentation, no kinematic measurements will be taken. The placement of the synthetic ligament will be measured. The research project will have the following key deliverables: Deliverable 1: Report detailing the following: The mechanical environment of the tibia pre- and post implantation The optimised design for the novel TKR with keel geometry Instrumentation platform design Mechanical integrity of the design Deliverable 2: Report detailing the following: The surgical procedure for the novel TKR Kinematic data from the first cadaver session Necessary alterations to the novel TKR following the first cadaver session Kinematic data from the second cadaver session Deliverable 3: Report detailing the instrumentation assessment from the cadaver trial. Deliverable 4: Manufacture of the finished novel TKR. Deliverable 5: Manufacture of the finished instrumentation set. Deliverable 6: Exploitation plan for the delivery of the novel TKR to healthcare providers.


Research activity codes: 5.4 SURGERY;5.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL