PARTIAL HIP MIA SYSTEM
Minimally invasive partial hip replacement MIA system
STAGE I · TRL 1-3
Prototype concept design with 3D design software
Minimally invasive femoral head removal tests on anatomical pieces (SCIENTIFIC ANATOMY)
THE PROBLEM
DISPLACED INTRACAPSULAR HIP FRACTURES IN PATIENTS OVER 80 YEARS OF AGE
20-25% of hip fractures worldwide are displaced intracapsular fractures in patients over 80 years of age
HIP FRACTURES
They pose a real challenge to all healthcare systems worldwide because of the extraordinary economic costs involved.
Depending on where the fracture is located:
Extracapsular: outside the hip articular capsule. Approximately 50% of the total
Intracapsular: inside the hip articular capsule. Approximately 50% of the total
Non-displaced (Garden I-II)
Displaced (Garden III-IV)
THE FOURTH AGE
Reaching 80 years of age marks the beginning of the “fourth age”.
Fourth-age patients are usually weak, polymedicated, suffer reduced physical activity and, in many cases, have functional dependency on basic activities of daily living. It is called the “frail elderly“.
The goal for treating these fractures in fourth-age patients is to allow them to recover their ability to walk with the least possible surgical aggression in order to shorten their bedridden hospital stays and their hospitalization.
HIP REPLACEMENT SURGERY
The treatment indicated for displaced intracapsular hip fractures in fourth-age patients is the hip replacement.
Current hip replacement surgery poses a number of risks and complications which cause the aggravation of illnesses in the elderly patient at the time of fracture and which carry also serious consequences.
Current hip replacement surgery does NOT meet the goals for the treatment of these fractures
THE SOLUTION
PARTIAL HIP MIA SYSTEM
MINIMALLY INVASIVE PARTIAL HIP REPLACEMENT MIA SYSTEM
To achieve a minimally invasive partial hip replacement, specific instruments and arthroplasty components have been developed to overcome the following technical problems:
How to perform the removal of the femoral head in a minimally invasive way
To solve the first problem, an innovative surgical instrument set has been designed to allow for the minimally invasive Femoral Head Removal (FHR Instrument set) through two small incisions; minimizing the aggressiveness with respect to the current surgical technique for the femoral head removal.
How to perform a partial hip replacement also in a minimally invasive way once we have removed the femoral head
To solve the second problem, an innovative hip prosthesis (MIHA Prosthesis) and its specific instrument set to place it in a minimally invasive way (MIHA Instrument set) have been designed.
The components of the MIHA prosthesis are inserted and assembled together in a guided way by the same 2 small incisions used to remove the femoral head.
THE PARTIAL HIP MIA SYSTEM is the first designed system within the MIA project which aims to minimize the aggressiveness of the treatment for these fractures
The PARTIAL HIP MIA SYSTEM meets the goal for treating these fractures in fourth-age patients
COMPONENTS
FHR Instrument set for the Minimally Invasive Femoral Head Removal
CANULATED FEMORAL HEAD EXTRACTOR
This new extractor is cannulated allowing for its insertion into the femoral head guided by a Kirschner wire.
It has retractable claws that can be opened from the outside increasing the grip of the extractor to the femoral head.
COMPONENTS
MIHA PROSTHESIS
Minimally Invasive Hip HemiArthoplasty
The MIHA prosthesis is a hybrid between a standard partial hip prosthesis and a proximal femoral intramedullary nail
For the design of the MIHA prosthesis, a standard partial hip prosthesis has been divided into 3 components and 2 screws.
The 3 components and 2 screws of the MIHA prosthesis can be inserted and assembled together precisely by the 2 small incisions through which we have previously removed the femoral head.
In order to achieve this, a specific introducer has been designed for each of them.
COMPONENTS
MIHA prosthesis placement Instrument Set
An introducer has been designed for each of the components of the MIHA prosthesis
ACETABULAR COMPONENT INTRODUCER
DIAPHYSEAL NAIL INTRODUCER
CERVICO-METAPHYSEAL COMPONENT INTRODUCER
MECHANICAL TESTS
The Institute of Biomechanics of Valencia (IBV) has carried out the mechanical tests of the MIHA prosthesis in titanium alloy Ti6AI4V according to the ISO 7206-4:2010
STRESS MECHANICAL TESTS
Maximum force reached: 9789 N
FATIGUE MECHANICAL TESTS
Fatigue testing of the MIHA prosthesis embedded in bone cement (PMMA) only on the distal part:
Alternating load from 822 N to 8 Hz reaching 1.000.000 cycles. Successfully surpassed.
Fatigue testing of the MIHA prosthesis implanted in synthetic bone:
Cyclic load of 2.300 N maximum at 10 Hz frequency till 5.000.000 cycles are reached. Successfully surpassed.
The Institute of Biomechanics of Valencia (IBV) (www.ibv.org) is considered a point of reference in Spain and in Europe for the biomechanical evaluation of products and services in the healthcare technology field.
It is located within the Universidad Politécnica de Valencia (UPV) campus where more than 1600 scientists work on different projects.
The Universidad Politécnica de Valencia (UPV) (www.upv.es) is amongst the universities in Spain which earn more revenue regarding competitive research, R&D contracts, consulting services, service provision and technology licenses. It is also the national leader in patent exploitation.
PARTIAL HIP MIA SYSTEM DEVELOPMENT STAGES
2015-2017
2017-2018
STAGE II · TRL 4-5
Design and development of the instrument set for the removal of the femoral head in a minimally invasive way (IBV)
Design and development of the MIHA prosthesis (IBV)
Design and development of the MIHA prosthesis placement instrument set (IBV)
Testing on anatomical pieces with 3D-printed polyamide prototypes (SCIENTIFIC ANATOMY)
2018-2019
STAGE III · TRL 6-7
Manufacture of the MIHA prosthesis in titanium alloy Ti6AI4V (MIPESA)
Mechanical validation of the MIHA prosthesis in titanium alloy Ti6AI4V according to ISO 7206-4:2010 (stress test and fatigue test) (IBV)
Funcional validation using anatomical pieces of the MIHA prosthesis in titanium alloy Ti6AI4V and instrument sets (SCIENTIFIC ANATOMY)
2020-2022
STAGE IV · TRL 8-9
CLINICAL TRIAL AND CE MARKING
Manufacture of the MIHA prosthesis, the FHR instrument set and the MIHA instrument set to carry out a clinical trial on humans (IVALMED, MIPESA)
Clinical trial design (CRO EXPERIOR)
Conducting the clinical trial (HOSPITAL UNIVERSITARIO Y POLITÉCNICO LA FE in Valencia)
Processing and procurement the CE marking (CLOQUELL CONSULTING)
SOCIOECONOMIC IMPACT
The length of stay in hospital is the most important cost factor in the treatment of hip fractures
THE COST OF HIP FRACTURES
Hip fractures pose a hefty economic and social impact. In the latest Spanish National Hip Fracture Register Report (2018), the annual cost of this type of fracture in Spain reaches 1.591 million euros.
In the United Kingdom, the cost of each hip fracture per patient is estimated at more than 37.000€ and more than 40.000$ in the USA.
The potential global market for the PARTIAL HIP MIA SYSTEM nears 450.000 units per year
HIP FRACTURES WORLDWIDE
A total of 1.800.000 hip fractures are estimated per year worldwide:
Around 450.000 of them are displaced intracapsular fractures in fourth-age patients.
In 2040 around 1.5 million fourth-age people worldwide will suffer a displaced intracapsular hip fracture indicated to be treated with the PARTIAL HIP MIA SYSTEM
WORLD AGING POPULATION FORECAST
Currently, the number of people in the world aged 80 years and over is 57 million (0.7% of the population). According to the United Nations, this number is expected to increase up to 199 million people (2.3% of the population) by 2030, and 430 million people (4.4% of the population) by 2050.
It is estimated that more than 6 million people will suffer a hip fracture by 2040 worldwide and 20-25% of those fractures will be displaced intracapsular hip fractures in fourth-age patients.
ADVANTAGES OF THE PARTIAL HIP MIA SYSTEM
The PARTIAL HIP MIA SYSTEM has achieved a milestone in the history of traumatology and orthopaedic surgery worldwide: to replace the hip joint in a minimally invasive way, quickly, simply and performed by a single surgeon
PATIENT BENEFITS
Reduction of surgery aggressiveness: minimally invasive surgery.
Reduction in approach and soft tissue dissection.
Reduction of blood transfusions and bleeding.
Reduction of surgical time.
Reduction of pre-surgery waiting time.
Reduction of post-operative medical complications.
Reduction of treatments to deal with complications.
Reduction of length of stay in hospital.
Maintaining independence for basic activities of daily living.
Improvement in short-term and long-term prognosis.
PARTIAL HIP MIA SYSTEM will save billions of dollars in all healthcare systems around the world
BENEFITS FOR THE HEALTHCARE SYSTEMS
Reduction of direct costs
Surgery performed by only 1 surgeon.
Reduction of post-surgery complications. Therefore, treatments received and the length of hospital stays are reduced.
Reduction in the number of assessments from other specialists for the treatment of complications: internal medicine, pneumology, nephrology, cardiology, etc.
Reduction of indirect costs
Reduction of nursing homes admissions.
Reduction of hospital readmissions.
Reduction of rehabilitation and physiotherapy needs.
Reduction of sick leave requests by relatives who take care of the patient.
Increased availability of hospitals beds.
Increased availability of surgeons in hospitals.
Reduction of waiting lists for other pathologies.
Each day of hospital stay that is saved with the PARTIAL HIP MIA SYSTEM will mean a saving of 100 millions of euros for the European healthcare systems.
COMPETITION IN THE HIP JOINT REPLACEMENT MARKET
The global trend in the hip replacement market is the minimally invasive surgery
The PARTIAL HIP MIA SYSTEM is the only minimally invasive PARTIAL hip replacement system specifically designed to treat displaced intracapsular hip fractures in fourth-age patients
Until now, for the treatment of degenerative hip diseases in adults, manufacturers have focused on the minimally invasive TOTAL hip replacement.
To this end, they have developed different instrument sets and mini femoral stems that allow to perform a minor approach regarding the conventional hip arhroplasty surgery.
There is no company on the global market with a minimally invasive partial hip replacement system designed to treat displaced intracapsular hip fractures in patients over 80 years of age.
DIFFERENCES WITH THE REST OF MANUFACTURERS
The PARTIAL HIP MIA SYSTEM has been developed to perform a PARTIAL hip replacement, for this reason there is no need to expose the pelvic acetabulum.
This reduces the number of instruments needed to perform the surgery and reduces the size of the incision compared to conventional minimally invasive surgery.
The positioning of the MIHA prosthesis components is similar to the positioning of the components of a proximal femoral intramedullary nail. For this reason, the learning curve required by surgeons to implant the MIHA prosthesis is very short, surgery is faster (30 minutes approx.) and is performed by a single surgeon.
The new PARTIAL HIP MIA SYSTEM is based on a different concept: a new and innovative partial modular hip prosthesis, the MIHA prosthesis, with its specific instrument set that allows it to be implanted in a minimally invasive way
RENDERS
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