MULTI-CENTRED CLINICAL EVALUATION OF A NOVEL KERATOPROSTHESIS
Funder
National Health and Medical Research Council
Funding Amount
$515,091.00
Summary
The prosthesis developed by applicants, known also as Chirila keratoprosthesis, is an artificial implantable device designed to replace a diseased cornea or a failed corneal graft, and can be used in patients with no hope for a conventional replacement of the cornea with donor tissue. The device may ultimately find a wider application, as it has the potential to give better visual results than human donor grafts. Even when not rejected, the donor grafts may lead to problematic healing patterns a ....The prosthesis developed by applicants, known also as Chirila keratoprosthesis, is an artificial implantable device designed to replace a diseased cornea or a failed corneal graft, and can be used in patients with no hope for a conventional replacement of the cornea with donor tissue. The device may ultimately find a wider application, as it has the potential to give better visual results than human donor grafts. Even when not rejected, the donor grafts may lead to problematic healing patterns and astigmatism, both limiting the final vision of patients. From the 45 million blind people worldwide, at least 10 million are due to corneal diseases or trauma. The figures released by WHO suggest a doubling of this number by year 2020. Many countries are unable to provide sufficient donor corneas, sometimes for cultural-religious reasons. In developed countries, the replacement with donor tissue is a common procedure, but many patients remain untreated because their prognosis for successful grafting is poor. Figures released in Australia show that long-term success of donor transplantation is unlikely in the patients identified as high-risk recipients. Furthermore, even technically successful cases show disppointing final vision. The significance of the applicants' artificial cornea is that allows high-risk, or otherwise untreatable corneal blind patients, to have their vision restored, and it could ultimately reduce the need for donor corneal tissue. A phase I pilot study has been completed, and Phase II is currently underway with support from NH and MRC. These studies showed that the Chirila KPro is an effective means of reversible replacement of a diseased cornea.The proposed Phase III will evaluate both safety and effectiveness in different categories of patients in comparison with published outcomes of donor grafting, and will establish unequivocally the clinical potential of this prosthesis.Read moreRead less
Regulation Of Key Pathways Causing Peri-implant Bone Loss.
Funder
National Health and Medical Research Council
Funding Amount
$403,639.00
Summary
The failure of bone prostheses is becoming a major health problem in our aging population. Despite the impressive success of joint replacement surgery, a significant number of arthroplasties fail. It is now apparent that most implants fail due to bone loss around them which leads to loosening. This project aims to obtain a better understanding of the causes of implant failure and find ways to extend the life of these implants .
Determination Of Irradiation Dose Efficacy For Use In Impaction Grafting At Revision Joint Replacement
Funder
National Health and Medical Research Council
Funding Amount
$411,517.00
Summary
Primary hip replacement is a successful intervention for hip disease, but 10-15% of hip prostheses fail and require revision surgery within 10-15 years. At the time of revision, significant bone loss around the failed prosthesis is not uncommon. A bone reconstruction procedure, called impaction grafting, where donor bone is minced and placed in the areas of deficient bone before implanting the new prosthesis, has shown to give good results at more than ten years in some centres. A high incidence ....Primary hip replacement is a successful intervention for hip disease, but 10-15% of hip prostheses fail and require revision surgery within 10-15 years. At the time of revision, significant bone loss around the failed prosthesis is not uncommon. A bone reconstruction procedure, called impaction grafting, where donor bone is minced and placed in the areas of deficient bone before implanting the new prosthesis, has shown to give good results at more than ten years in some centres. A high incidence of early complications of this procedure have included loss of fixation within the bone. Fracture of the bone around prostheses has also reported in some centres. These events require more surgery, putting the patient at higher risk greater complications and longer rehabilitations. Recent improvements in surgical technique and donor bone preparation have improved results. A current debate questions whether the dose of irradiation can be reduced from 25 kGy, while maintaining sterility of allografts. The risk of bacterial contamination in allografts is low, and irradiation reduces the mechanical strength of the graft, contributing to complications when irradiated bone is used. The benefits of decontaminating the bone may be outweighed by the higher risk for failure due to poor bone quality and resulting prosthesis instability. We will use ISO standards to test the validity of radiation dose for sterilising bone ex vivo. In the absence of controlled human studies, our aim is also to compare the results of impaction grafting with non-irradiated bone versus bone irradiated at current doses used by Australian bone banks, and lower doses indicated by ex vivo testing. We will use a large animal model of revision hip replacement, with precise measures of prosthesis stability. The results of this study will guide clinical decisions regarding the efficacy of current bone graft preparation procedures and the use of irradiated bone in human hip replacement surgery.Read moreRead less