PARTIAL HIP SYSTEM

PARTIAL HIP SYSTEM

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THE PROBLEM

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)

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 FRACTURES THE FOURTH AGE

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.

WomenGermany 215 392 685 1158 2090Austria 23 411 845 1773 3132

Belgium 140 271 606 1263 2371Denmark 274 561 1087 1983 3701

Spain 75 179 386 858 1709France 107 218 483 1076 1894Greece 198 436 707 1281 1855

Hungary 156 285 557 1385 2684Ireland 147 302 614 1231 2143

Italy 144 293 613 1214 2105Netherlands 108 220 480 887 1468

Portugal 98 239 516 983 1700U.K. 132 282 619 1236 2255

Sweden 264 456 1006 1817 3082

65-69 70-74 75-79 80-84 +8565-69 70-74 75-79 80-84 +85

Men122 223 338 741 1100162 262 470 924 1652104 159 313 669 1371201 315 592 1189 224254 103 190 387 81172 120 239 508 942

102 220 363 725 1087142 190 377 872 166076 143 264 519 101475 135 277 579 114573 127 247 528 91961 128 226 424 789

107 176 313 623 1220150 260 495 1163 1623

Incidence rate of Hip Fractures per 100.000 people by age group in 2010. Age groups over the age of 80 are highlighted

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PARTIAL HIP SYSTEMDOSSIER

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.

HIP REPLACEMENT SURGERY

Current hip replacement surgery does NOT meet the goals for the treatment of these fractures

Aggressive surgery with large incisions Large surgical approaches to expose the pelvic acetabulum Large soft tissue dissection Bleeding during and after surgery Postoperative anemia requiring blood transfusions Complications during cementation Superficial and deep infection Hip arthroplasty dislocation

HIP REPLACEMENT SURGERY

Increase in treatments received Increase in blood transfusions

Increase in bedridden days

Delayed ability to walk after surgery Increased length of stay in hospital Physical and mental impairment Dependent in basic activities of daily living Nursing home admission Death

WORSENING OF PATIENT’S ILLNESSES

PATIENT + 80 YEARS + DISPLACED INTRACAPSULAR HIP FRACTURE

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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.

THE SOLUTION PARTIAL HIP MIA SYSTEMMINIMALLY INVASIVE PARTIAL HIP REPLACEMENT MIA SYSTEM.

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COMPONENTSFHR INSTRUMENT SET FOR THE MINIMALLY INVASIVE FEMORAL HEAD REMOVAL

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.

CANNULATED FEMORAL HEAD EXTRACTOR

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MIHA PROSTHESISMINIMALLY INVASIVE HIP HEMIARTHROPLASTY

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.

The MIHA prosthesis is a hybrid between a standard partial hip prosthesis and a proximal femoral intramedullary nail.

Acetabular Component

Diaphyseal Nail

Blocking Screw

Distal locking Screw

Cervico-Metaphyseal Component

Stabilizes the Cervico-Metaphyseal Component and the Diaphyseal Nail

Similar to proximal femoralintramedullary nail

Femoral head substitute

Connects the Acetabular Component with the Diaphyseal Nail

COMPONENTS

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MIHA PROSTHESIS PLACEMENT INSTRUMENT SET

ACETABULAR COMPONENT INTRODUCER

CERVICO-METAPHYSEAL COMPONENT INTRODUCER

COMPONENTS

DIAPHYSEAL NAIL INTRODUCER

An introducer has been designed for each of the components of the MIHA prosthesis

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MECHANICALTESTS

Maximum force reached: 9789 N

STRESS MECHANICAL TESTS

FATIGUE 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

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.

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PATENTS

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

SPANISH PATENT (P20183056)Filed in June 11, 2018.

PCT (ES2019/070399) Filed in June 10, 2019.PCT (ES2019/070399)

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PARTIAL HIP SYSTEM DEVELOPMENT STAGES

Prototype concept design using 3D design software. Minimally invasive femoral head removal tests on anatomical pieces (SCIENTIFIC ANATOMY).

STAGE I · TRL 1-32015-2017

STAGE II · TRL 4-52017-2018

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).

20152016

20172018

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STAGE III · TRL 6-72018-2019

STAGE IV · TRL 8-92020-2022

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).

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).

20192020

20212022

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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.

Factors associated with hip fracture costs:

Surgery itself Implanted material Length of stay in intensive care (if required) Length of stay in hospital Nursing and staff costs Costs of treatments used Image tests Lab tests Transfusions

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.

THE COST OF HIP FRACTURES HIP FRACTURES WORLDWIDE

The potential global market for the PARTIAL HIP MIA SYSTEM nears 450.000 units per year

The length of stay in hospital is the most important cost factor in the treatment of hip fractures

SOCIOECONOMICIMPACT

Hip fractures worldwide:

200

700

650

550

100

600

500

400

350

250

150

50

450

0

300

Spain USAJa

pan

Europe

China

Thou

sand

s of

frac

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50

650

300

153

600

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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.

WORLD AGING POPULATION FORECAST

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.

10.000

9.500

9.000

8.500

8.000

7.500

7.000

20182030

20402050

Total populationM

illio

ns o

f peo

ple

7.597

8.500

9.157

9.725

Mill

ions

of p

eopl

e

57

199

313

430

300

250

200

150

100

50

0

20182030

20402050

Population +80 years

400

350

450

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ADVANTAGES OF THE PARTIAL HIP SYSTEM

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

PATIENT BENEFITSThe 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.

Standard Hiparthroplasty approach

Partial HIP MIA Systemapproach

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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

BENEFITS FOR THE HEALTHCARE SYSTEMS

PARTIAL HIP MIA SYSTEM will save billions of dollars in all healthcare systems around the world

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

Hospital stay days saved with the PARTIAL HIP MIA SYSTEM

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4 days

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7 day

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8 days

9 days

10 day

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100

200300

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600700

800900

10001000

1200

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COMPETITION IN THE HIP JOINT REPLACEMENT MARKET

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.

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.

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.

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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.

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.

Standard hiparthroplasty

surgery

Minimally invasive surgery

TISSUE SPARING PARTIAL HIP MIA SYSTEM

4º age fractures No No YesIncision 18-20 cm 8-12 cm 2+3-5 cmSpecífic instruments Yes Yes YesProsthesis Standard Standard MIHA ProsthesisApproach/Capsulotomy Sup/Ant/Post/Lat Sup/Ant/Post/Lat Superior/AnteriorTissue-sparing No Yes YesCapsule preservation No Yes YesLeg positioner No Yes (Ant) NoFamiliar patient position Yes No (Ant) Yes

Known anatomical Ref. Yes No (Ant) Yes

Nerve injury Yes Yes NoExtensile approach Yes No (Ant) Yes/NoHip joint exposure Yes Yes Sup: No/Ant: YesLearning curve Long ++ Long +++ ShortSurgery time 80-120 min 80-120 min 30 minNº surgeons 2-3 2-3 1

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Bipolar Prosthesis

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BIBLIOGRAPHY

-RNFC - Registro Nacional de Fracturas de Cadera. España. Informe Anual 2018. http://rnfc.es/-NHFD - National Hip Fracture Database. United Kingdom. Annual Report 2019. https://www.nhfd.co.uk/-Australia and New Zealand Hip fracture Registry Annual Report 2019. https://anzhfr.org/-Svedbom A, Hernlund E, Ivergård M, et al. Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos. 2013;8(1-2):137. doi:10.1007/s11657-013-0137-0

-United Nations. Department of Economic and Social affairs. World Population Prospects 2019. https://population.un.org/wpp/Publications/Files/WPP2019_Highlights.pdf

-Khasraghi FA, Lee FJ, Christmas C, Wenz JF. The economic impact of medical complications in geriatric patients with hip fracture. Orthopaedics 2003 Jan;26(1):49-53; discussion 53.

-WHO - World Health Organization. Prevention and management of Osteoporosis. Report of a WHO scientific group https://apps.who.int/iris/bitstream/handle/10665/42841/WHO_TRS_921.pdf?sequence=1&isAllowed=y

-Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C, Epidemiology IOFWGo, Quality of L: A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int 2012;23:2239-2256. DOI: 10.1007/s00198-012-1964-3.

-Matsuo M, Yamagami T, Higuchi A: Impact of age on postoperative complication rates among elderly patients with hip fracture: a retrospective matched study. J Anesth 2018;32:452-456. DOI: 10.1007/s00540-018-2494-8.

-Ortiz-Alonso FJ, Vidan-Astiz M, Alonso-Armesto M, Toledano-Iglesias M, Alvarez-Nebreda L, Branas-Baztan F, Serra-Rexach JA: The pattern of recovery of ambulation after hip fracture differs with age in elderly patients. J Gerontol A Biol Sci Med Sci 2012;67:690-697. DOI: 10.1093/gerona/glr231.

-Shah MR, Aharonoff GB, Wolinsky P, Zuckerman JD, Koval KJ: Outcome after hip fracture in individuals ninety years of age and older. J Orthop Trauma 2001;15:34 39. DOI: 10.1046/j.1532-5415.2001.49121.

-Mayordomo-Cava, J., Abásolo, L., Montero-Fernandez, N., Ortiz-Alonso, J., Vidán, M. T., & Serra-Rexach, J. A. (2020). Hip fracture in nonagenarians: Characteristics and factors related to 30-day mortality in 1177 patients. The Journal of Arthroplasty. doi:10.1016/j.arth.2019.12.044

-Centre NCG. The management of hip fracture in adults. NICE; 2011 Updated 2014. Available from: https://www.nice.org.uk/guidance/cg124/evidence/full- guideline-183081997.

-Surgeons AAoO. Management of hip fractures in the elderly. American Academy of Orthopaedic Surgeons; 2014. https://www.aaos.org/globalassets/quality-and-practice-resources/hip-fractures-in-the-elderly/hip-fractures-elderly-clinical-practice-guideline-4-24-19--2.pdf

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Minimally Invasive Arthroplasty

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PARTIAL HIP SYSTEM