Awaiting Public Project Summary
Awaiting Public Project Summary
Osteoarthritis is a crippling disease caused by damage to cartilage and the underlying bone in the body's joints. Arthritis Research UK have estimated that osteoarthritis will cost the NHS £118.2bn between 2017 and 2027\. The only widely accepted treatment for osteoarthritis is replacement of the joint with a large, permanent implant. This requires major surgery which takes several months to fully recover from and while often successful there are variable outcomes and it is not recommended for younger patients. As osteoarthritis can develop early in a person's life this means many patients cannot currently be treated effectively.Orthox, a small UK medical-technology company, and Stryker, a major multinational company, have developed innovative materials to repair cartilage and bone. Orthox has created FibroFix: a unique cartilage repair material made from silk that combines the smooth, slippery, resilient and robust characteristics of human cartilage with a structure that supports regrowth of the patients own cartilage tissue. FibroFix has shown promise in pre-clinical and early human trials. Stryker have invented Tritanium: a material that is 3D printed from titanium and can knit with bone. Tritanium has demonstrated good results in patients and is used in implants for the spine, hip and knee.Over the previous 2 years, the partners have collaborated to combine these cartilage and bone repair materials, creating Silk-Ti technology: early stage implants which aim to replace damaged bone and cartilage. These implants will attempt to offer patients who have damaged their cartilage and bone, and who may also have osteoarthritis, a much less painful operation which removes less healthy tissue than joint replacement surgery. This, combined with both material's strength, may also allow patients to recover much more quickly from the surgery while long-term the patient's own cartilage and bone tissue should grow into the implants, holding them firmly in place and helping the implant to function better. Stryker also have a robotic surgery system which may help surgeons fit Silk-Ti implants more accurately into the joint leading to better results.Silk-Ti materials have shown encouraging preliminary results in mechanical and early surgical testing.This project will:1\. Further develop Silk-Ti manufacturing capability at Orthox,2\. Complete comprehensive mechanical testing of the combined materials to confirm the implants work in the lab3\. Identify the most appropriate joints for the Silk-Ti technology to target4\. Develop early stage Silk-Ti implants for these joints.5\. Conduct preliminary testing of these implants.
This project will further develop an implant to restore mobility and prevent deterioration of the knee joint in patients suffering from injuries to the meniscal cartilage in their knees. The implant is made from a novel material called FibroFix which is formed from a protein extracted from silk fibres called fibroin. The properties of fibroin give FibroFix devices unique advantages, allowing them to be very strong, smooth and resilient like cartilage itself, while also capable of regenerating new cartilage tissue. Further development of the FibroFix implant on this project will allow it to be used to treat the meniscal cartilage on both sides of the knee joint and also to treat the more demanding, larger, injuries to the meniscal cartilage where the painful condition osteoarthritis would otherwise be very likely to develop. The project will finalise development of this implant and complete testing in large scale trials, demonstrating that it is both safe and effective. Once this has been achieved, the project will investigate the implant’s performance in a clinical trial and scale up manufacture to enable the implant to be ready for the large patient poulation once market approval has been secured.
This project will develop an implant to reduce pain and restore mobility to patients suffering from injuries to the cartilage in their knees. The implant is made from a novel material called FibroFix™ which is formed from a protein extracted from silk fibres called fibroin. The properties of fibroin give FibroFix™ devices unique advantages, allowing them to be very strong, smooth and resilient like cartilage itself, while also capable of regenerating new cartilage tissue. This will allow the FibroFix™ implant to be used to treat large injuries to the articular cartilage in the knee where the painful condition osteoarthritis may already be present. The project will finalise development of this implant and complete testing in animal and laboratory trials, demonstrating that it is both safe and effective. Once this has been achieved, the project will investigate the implant’s performance in a clinical trial.
Cartilage acts as a shock absorber and an articulating surface in human joints. Cartilage defects often progress to severe osteoarthritis (OA), and eventually, total joint replacement is frequently required. The project will develop FibroFix Composite, an extremely tough new biomaterial and will deliver this in anatomically congruent, high strength, tissue regenerative cartilage repair prototypes for load bearing clinical indications. Current FibroFix device attributes of mechanical strength, resilience, and smooth surface characteristics will be enhanced through addition of components to increase resistance to tensile, torsional and shear forces. These properties will afford the possibility of employing FibroFix Composites in a wide cross section of clinical indications in which significant mechanical forces are experienced. Inexpensive production, keyhole implantation and competition limited by the aggressive environment will enable clear market differentiation and rapid uptake.
The meniscus has a poor blood supply and as a result ~90% of injuries do not heal. In the
majority of these cases, surgery is required to remove the damaged tissue which if left
untreated causes significant discomfort and impairs mobility (1). The surgical procedure, a
partial meniscectomy, alleviates the symptoms but destabilises the knee joint, resulting in
uneven load distribution and an increased likelihood of developing OA and the eventual
requirement for TKR (2,3,4,5). Although old age brings an increased risk of meniscal tears,
the injury is most commonly observed in patients aged 11-44 for whom TKR is not a viable
option (6). The result is long term disability for these patients.
The meniscus plays a very demanding role in the knee joint, carrying up to 80% of the load
placed on the knee. When running and jumping, meniscal load will frequently exceed 8 times
body weight. The combination of poor blood supply and demanding mechanical role mean
there are few available therapies that can deliver either meniscal regeneration or functional
replacement. We believe FibroFix is the only device capable of offering both (see appendix A
and B).
Developed through awards in 2009 and 2010 of £1.6m from the Wellcome Trust and £269k
from The TSB Regenerative Medicine programme, FibroFix is an advanced prototype
implantable medical device. Short term pilot study large animal data on the device is positive,
demonstrating stable fixation, biocompatibility, mechanical performance and initial
chondroprotection. Simultaneously, significant advances have been made developing the
GMP production processes required for ISO13485 accreditation and successful implantations
in human cadavers to develop the surgical technique have been conducted in partnership with
corporate multinational, ArthrexGmbh. An award in April 2011 of £732k from the NIHR i4i
Programme to an Orthox led consortium provides funds to further develop the FibroFix
device and manufacturing process and evaluate the outputs in vitro, and through a pilot human
clinical study.
However, restrictions on the i4i programme preclude preclinical in vivo work being funded.
Therefore, the project described in this application will deliver the pivotal proof of concept
long term in vivo efficacy study required to complement the work on the i4i programme,
ensuring expeditious translation of FibroFix into the clinic.
Devices developed on the i4i project will be trialled in a 6 month sheep meniscal repair study.
This will be conducted to GLP standard, required for regulatory submissions, and
subcontracted to Northwick Park Institute for Medical Research (NPIMR) under the
supervision of Dr Paul Sibbons, with whom Orthox have a longstanding existing
collaboration. The results are expected to be completed within 12 months of the project start
and included in the design history file for the submissions to gain approval for initiation of the
pilot human clinical study in Q4 2012.