Periodic Reporting for period 1 - BioMech-3D (SENIOR BIOMECHANICAL 3D MODELLING RESEARCHER)
Reporting period: 2019-12-31 to 2020-12-30
Patient‐specific orthopedic implants is a clinically promising treatment option for total hip replacement (THR) to better match an individual's bone anatomy. Such implants would help to reduce overall procedural costs, minimize surgical time, and maximize patient outcomes by achieving better implant fit. Nowadays pre-surgical joint replacement software tools evaluate only 3D models of bones reconstructed from CT images, disregarding biomechanics of joints of individual patient. Biomechanical evaluation helps to predict how implant design and positioning would affect joint function after THR. Absence of biomechanical evaluation may lead to non-predictable and undesirable long-term mechanical effects on replaceable joint area and other related joints. Therefore, Ortho Baltic aims to develop a surgeon-friendly 3D biomechanical simulation functionality for the use in preoperative planning stage of joint replacement surgery in a 3D models-based pre-surgical planning software MICE.
Joint replacement surgery is one of the most frequently performed and effective surgeries worldwide. The aim of joint replacement is to relieve pain, restore biomechanical function and improve quality of life for patients. THR is a surgical procedure in which the hip joint is replaced by a prosthetic implant. It is normally conducted to relieve arthritis pain or treat severe physical joint damage following hip fracture. The OECD (OECD Health Statistics 2019) averages are 182 per 100 000 population for THR. Demographic change (increased mean age in population), increasing life expectancy, ongoing development of medical care, and economic growth resulted in a growth of THR surgeries. Therefore, the long-term survivorship of THR implants is increasingly relevant. As more patients undergo THR in younger age, the rate of revision hip implant surgeries due to complications has risen sharply due to higher mobility of patients. All hip replacements would eventually fail if in situ long enough because of processes such as infection, fracture, or a combination of normal tribological and biological processes, such as loosening and wear (Evans et al. 2019). The vast majority of THR are successful but approximately 5% of people who receive a hip implant may require revision surgery within 10 years, and 15% of patients needed revision surgery within 20 years (Evans et al. 2019). The most common reasons for revision are: mechanical failure of implant, periprosthetic bone fracture, repetitive dislocation, and infection. Revision THR causes growing and leads to important clinical and economic challenges in developed countries worldwide.
The goal of BioMech-3D was to add biomechanical evaluation to the workflow (Figure 1) of the design of the subject-specific hip implant for THR surgery; this would help to estimate how hip implant design/position would affect the hip joint function and to define the optimal implant design to restore the joint function. Further, this functionality will be used for planning of subject-specific implants on other human joints and will be integrated to MICE.
Joint replacement surgery is one of the most frequently performed and effective surgeries worldwide. The aim of joint replacement is to relieve pain, restore biomechanical function and improve quality of life for patients. THR is a surgical procedure in which the hip joint is replaced by a prosthetic implant. It is normally conducted to relieve arthritis pain or treat severe physical joint damage following hip fracture. The OECD (OECD Health Statistics 2019) averages are 182 per 100 000 population for THR. Demographic change (increased mean age in population), increasing life expectancy, ongoing development of medical care, and economic growth resulted in a growth of THR surgeries. Therefore, the long-term survivorship of THR implants is increasingly relevant. As more patients undergo THR in younger age, the rate of revision hip implant surgeries due to complications has risen sharply due to higher mobility of patients. All hip replacements would eventually fail if in situ long enough because of processes such as infection, fracture, or a combination of normal tribological and biological processes, such as loosening and wear (Evans et al. 2019). The vast majority of THR are successful but approximately 5% of people who receive a hip implant may require revision surgery within 10 years, and 15% of patients needed revision surgery within 20 years (Evans et al. 2019). The most common reasons for revision are: mechanical failure of implant, periprosthetic bone fracture, repetitive dislocation, and infection. Revision THR causes growing and leads to important clinical and economic challenges in developed countries worldwide.
The goal of BioMech-3D was to add biomechanical evaluation to the workflow (Figure 1) of the design of the subject-specific hip implant for THR surgery; this would help to estimate how hip implant design/position would affect the hip joint function and to define the optimal implant design to restore the joint function. Further, this functionality will be used for planning of subject-specific implants on other human joints and will be integrated to MICE.
BioMech-3D project started in January 2020 and was completed successfully in December 2020 when all project aims and milestones were fully achieved. The Work plan consisted of four work packages, which were executed according to the plan and schedule (WP1. Training program and integration; WP2. Development of the innovation project by the associate; WP3. Project management; WP4. Ethics requirements). All deliverables and milestones were also implemented.
The individualized hip implant for THR surgery was designed based on analysis of 3D geometry of the bones of the patient and biomechanical evaluation of the patient-specific musculoskeletal model of the hip joint at the baseline and with the simulated implant, finite element analysis of the implant was performed; and the biomechanical evaluation was verified. Automatization methodology of musculoskeletal modelling and biomechanical analysis of hip implant was developed. Technical documentation of hip implant design was updated according ISO 13485.
The individualized hip implant for THR surgery was designed based on analysis of 3D geometry of the bones of the patient and biomechanical evaluation of the patient-specific musculoskeletal model of the hip joint at the baseline and with the simulated implant, finite element analysis of the implant was performed; and the biomechanical evaluation was verified. Automatization methodology of musculoskeletal modelling and biomechanical analysis of hip implant was developed. Technical documentation of hip implant design was updated according ISO 13485.
BioMech-3D project contributed to advancement in design and validation of patient-specific implants, better adjusted to individual patients’ clinical needs, and with reduced risk of revision surgery in a future. Developed methodology will be used by Ortho Baltic in a future in THR surgery planning. The nearest plan is to include biomechanical evaluation to the planning of temporomandibular joint implant and implementation of real-time biomechanical evaluation of implant design in web-based pre-surgical planning software MICE.