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EXCEEDING THE HIGHEST STANDARDS YOURS. Hip & Femur Fracture Solutions

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EXCEEDING THEHIGHEST STANDARDS

YOURS.

Hip & FemurFracture Solutions

2

We’re hip & femur fracture specialists -

providing the broadest portfolio of best in

class products and services, unparalleled

expertise, and the most expansive

resources in the industry. You never know

what your next patient may require; that’s

why you trust us to support everything you

might need.

Hip & Femur Fracture Solutions

Everything you need for everything you do

T R O C H A N T E R I C F R AC T U R E S

TFN-ADVANCED™ Proximal Femoral Nailing System (TFNA) with Augmentation

Hip Fracture Program

P E R I P R O S T H E T I C F R AC T U R E SLocking Attachment Plate (LAP)

Orthopaedic Cable System

Trochanteric Reattachment Device (TRD)

R E A M I N G

Reamer Irrigator Aspirator (RIA)

F E M O R A L N E C K F R AC T U R E S

Femoral Neck System (FNS)

CORAIL® Total Hip System

Self-Centering™ Bipolar and Modular Cathcart Unipolar Endo Heads

PINNACLE® Acetabular Cup System

S U B T R O C H A N T E R I C & S H A F T F R AC T U R E S

Femoral Recon Nail (FRN)

3

4 5

MORE CYCLESto varus collapse

UPTO

%346

INCREASE IN

TO CUT-OUTRESISTANCE

UPTO

%244

Simulated nail with 1.5m ROC

TFNA with 1.0m ROC

See pages 14 & 15 for information on the Hip Fracture Program.

T R O C H A N T E R I C F R A C T U R E ST R O C H A N T E R I C F R A C T U R E S

The TFNA system is designed to advance hip fracture treatment with surgical options to enhance

implant stability in poor bone and improved fit and strength. It incorporates the best elements of

our highly successful global hip nails, optimized through input from hundreds of surgeons around

the world. The TFNA System truly is a global platform that delivers modern innovation.

TFN-ADVANCED™ PROXIMAL FEMORAL NAILING SYSTEM (TFNA)

IMPROVED FIT AND STRENGTH

SURGICAL OPTIONS TO ENHANCE STABILITY IN POOR BONE

ANATOMIC 1.0M RADIUS OF CURVATUREMean total surface area of nail protrusion is 29% less than Gamma33

TIMo TITANIUM ALLOY & BUMP CUT DESIGNProvides improved fatigue strength when compared with existing nails of similar size2

15.66mmSMALL PROXIMAL

DIAMETER

LATERAL RELIEF CUT DESIGN

14.12mm

AUGMENTABLE HEAD ELEMENTSThrough extensive bench testing, augmentation has demonstrated its ability to increase resistance to head element migration.4,5  Since 2010, three European multi- center trials with over 150 patients have published reporting no incidences of revision, unexpected head element migration or related complications.6-8

HELICAL BLADE TECHNOLOGY Designed to improve implant anchorage, provide greater rotational stability and provide greater resistance to superior load when compared to a screw.9

PREASSEMBLED LOCKING MECHANISMStatic or rotational locking options that can be selected intraoperatively.

Compared to constructs with non-augmented head elements4, 5

Medial Femoral View

Superior Force Absorbed

LATERAL RELIEF CUTTM & SMALL PROXIMAL DIAMETER

Preserves bone in insertion area due to reduced critical width

TFNA Helical Blade TFNA Screw

Med

ian

Fatig

ue L

imit

(N)

TFNA System Gamma3 Intertan

1900

1800

1700

1600

1500

1400

1300

1200

1100

1000

24%DIFFERENCE

47%DIFFERENCE

FATIGUE LIMIT STUDY

6 7

F E M O R A L N E C K F R A C T U R E S F E M O R A L N E C K F R A C T U R E S

TARGETED INSERTION HANDLE

All steps of the procedure can be completed after placement of one central guide wire into the femoral head, enabling a repeatable approach

ROTATIONAL CONTROL

The FNS has up to a 40% increase in rotational stability when compared to a Sliding Hip Screw system10

GUIDED COLLAPSE

With a compact design, FNS isintended to minimize invasivenesson the patient including up to 20mmof guided collapse, without lateral protrusion of the bolt for the first 15mm

ANGULAR STABILITY

A published biomechanical study showsthat FNS offers 100% more resistanceto varus collapse (leg/neck shortening) when compared to multiple cannulated screws11

The Femoral Neck System (FNS) is designed for improved angular stability11 and rotational

stability10 with the intent to reduce reoperations related to fixation complications.

FEMORAL NECK SYSTEM (FNS)

ENHANCED FIXATION IN A COMPACT DESIGN

STREAMLINED PROCEDURE

HIP REPLACEMENT OPTIONS

Total Hip Arthroplasty

CORAIL® Hip System* with Self-Centering Endo Heads

Hemi Hip Arthroplasty

The CORAIL® Cementless Hip System is part of the CORAIL family of products. In a publication by Kendrick et. al., using a modern uncemented hip implant in a hemi-arthroplasty for intracapsular hip fracture provided satisfactory results, with a good rate of return to pre-injury place of residence and an acceptable mortality rate.12

Collapsed 15mm

CORAIL® Hip System with PINNACLE® Acetabular Cup System

The CORAIL® Hip System with a PINNACLE® Cup is one of the most widely used total hip constructs in the world. In 2017, the CORAIL Stem achieved over 2 million unit sales worldwide and the PINNACLE Cup reached over 2.5 million unit sales worldwide since their introduction.13,14

*CAUTION: CORAIL Dysplasia Size 6 Stem and CORAIL Cemented

Stems are contraindicated for hemiarthroplasty surgery

8 9

S U B T R O C H A N T E R I C & S H A F T F R A C T U R E S S U B T R O C H A N T E R I C & S H A F T F R A C T U R E S

With the introduction of the Femoral Recon Nail, DePuy Synthes offers a portfolio with

the choice of most used entry points.15 The FRN System offers the choice of Piriformis

Fossa (PF) or Greater Trochanter (GT) entry points and extensive locking options to

accommodate varying surgical preferences while enabling the treatment of a range of

fracture complexity. FRN was designed for anatomical fit with a 1.0m radius of

curvature and short proximal nail end to better fit patient anatomy.16,17

FEMORAL RECON NAIL (FRN)

DISTAL LOCKING

Four locking options including:

• An A/P hole

• Distal dynamization option

• An oblique distal locking hole offset 10 degrees

GREATER TROCHANTER OR PIRIFORMIS FOSSA

Accommodates surgeon preference

Top View Top View

CHOICE OF ENTRY POINTS

PROXIMAL LOCKING

Choice of standard locking, reconstruction locking or combined with proximal dynamization option

EXTENSIVE LOCKING OPTIONS

Simulated competitor nail with 1.5m ROC

FRN with 1.0m ROC

ANATOMIC 1.0M RADIUS OF CURVATURE (ROC)1.0m anatomic bow designed to help avoid impinging anterior cortex compared to nails with larger radius of curvature17

ANATOMICAL FIT

Simulated Zimmer PF

DePuy Synthes PF Femoral Recon Nail

LOWER PROXIMAL NAIL PROMINENCE

Short proximal nail end designed to reduce risk of nail prominence compared to nails with a longer nail end (i.e. Zimmer PF)16

10

8 outer bundles of 7 strands

One central bundle of 19 strands

P E R I P R O S T H E T I C F R A C T U R E S P E R I P R O S T H E T I C F R A C T U R E S

CROSSECTIONAL VIEW

PROVIDES STIFF, BICORTICAL FIXATION FOR INCREASED ROTATIONAL STABILITY

• LAP provides a stronger, stiffer construct than an orthopedic cable20

• Locking capability advantageous in osteopenic bone where screw purchase is compromised

• Contourable to accommodate patient’s anatomy

COMPATIBLE WITH EXISTING DEPUY SYNTHES 4.5MM LCP PLATES INCLUDING VA-LCP PLATES • Attaches to plate via a dedicated connection screw

at the locking hole of the plate• Available in 4-hole and 8-hole, in stainless steel

and titanium

CABLES FEATURE A UNIQUE WEAVE DESIGN TO ALLOW FOR GREATER FLEXIBILITY AND CONTROL

1.7 mm diameter, available in 316L stainless steel withstainless steel crimp and L605 cobalt chromium alloy with titanium crimp

As an alternative to cerclage cables, the 3.5mm Locking Attachment

Plate (LAP) preserves the periosteal blood supply and bypasses

a prosthesis stem with an angular stable solution.18,19

Comprehensive surgical options for cerclage fixation in

joint reconstruction and trauma procedures

3.5MM LOCKING ATTACHMENT PLATE ORTHOPAEDIC CABLE SOLUTIONS

CROSSECTIONAL VIEW

Cable Positioning Pinssecures cable to the plate and prevents cable migration

TROCHANTERIC REATTACHMENT DEVICE OPTION

For reattachment of the greater trochanter following

osteotomy in total hip arthroplasty or fracture

• Large proximal hooks grip the greater trochanter, securing its location while resisting superiorly directed forces

• Preassembled with 1.7 mm CoCr cables and titanium crimps

• Crimps reside in plate for easy access, handling, and cable alignment

• Available in TAN and in two lengths

11

R E A M I N G R E A M I N G

RIA is a proprietary single-pass reaming and a bone harvesting system

designed to reduce fat embolism and thermal necrosis that can occur

during reaming/nailing of long-bone fractures.

REAMER IRRIGATOR ASPIRATOR (RIA)

AUTOGRAFT RECOVERY

• Provide an efficient method for obtaining large volumes of autologous bone graft21

• Produce bone graft with high concentration of viable cells and growth factors22-26

LOWER PAIN SCORE

• Reduced complication rates compared to iliac crest bone graft (ICBG) harvesting28

• Reported lower mean pain scores for RIA donor sites when compared to ICBG donor sites across 60 weeks21,27

IMPROVED SAFETY

Demonstrated to reduce heterotopic ossification, fat embolization, pulmonary insult and thermal necrosis compared to standard reaming29-32

CLEARS CANAL

Removes infected and necrotic bone tissue.

FAST, EFFICIENT REAMING

• Time saving, one-step procedure 21

• Sharp reamer heads for optimized cutting

Tota

l Pai

n Sc

ore

(Poi

nts)

<48 hrs >48 hrs to >3 months < 3 months

14

12

10

8

6

4

2

0

MORSELIZED BONE MARROW OUTFLOW

IRRIGATION FLUID INFLOW

RIA

ICBG

LOWER PAIN SCORE STUDY

1312

14 15

Length of stay reduced from 9 to 7 days35

Significant reduction in costs for the hospital of €252,000/year35

Geriatrician support for elderly patients increased

from 44% to 92%35

Delivering Results

Demonstrated measurable results at the OLVG Hospital in Amsterdam

Care4Today® Hip Fracture ProgramAn evidence-based care improvement program for the elderly fragility fracture patient population that facilitates interdisciplinary care coordination and clinical standarization to reduce variation and costs, improve outcomes and optimize care.33,34

CareAdvantageOur approach to partnering with hospitals and healthcare providers in order to achieve the Triple Aim of enhancing patient experiences and improving outcomes, while reducing costs.

Program Components

• Implementation Support & Facilitation by clinical subject matter experts

• Implementation Toolbox includes best practice materials to guide through implementation

• On-site opportunity assessment includes interviews with multi-disciplinary key stakeholders

• Performance Dashboard and Diagnostic Health Check to track data, visualize progress and benchmark

Optimization of processes for fragility hip fractures that supports a coordinated interdisciplinary care pathway, potentially resulting in enhanced clinical outcomes and patient experiences, while reducing costs.

Emergency Department Pre-Operative Peri-Operative Discharge

Deploy Track

Measure

On-siteassessment

Data-drivenanalysis

Discussion of yourneeds

Our Patient Pathway capabilities are built with the patient at the centre to help ensure patients receive consistent, coordinated care, whilst supporting patients to take control of their own treatment and recovery

Empowering patients through shared decision-making and technology to take control of their own treatment and recovery

Driving consistency among the multi-disciplinary team across the entire patient

pathway episode

Providing continuity of care (in and out of the hospital

setting) throughout the patient journey

Solving starts with listening.

*Bench test results may not be indicative of clinical performance.

Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information.

This publication is not intended for distribution in the USA.

Not all products are currently available in all markets. The third party trademarks used herein are trademarks of their respective owners.

Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

© DePuy Synthes 2019. All rights reserved.097892-190307 DSEM

1. DePuy Synthes Sales Data on File. DRG Pricetrack Cephalomedullary Nail Marketshare Analysis, 2017.

2. DePuy Synthes Trauma. Data on File. Fatigue strength testing of cephalomedullary nails. 2014. Ref 0000131715, 0000122418.*

3. Schmutz B, Amarathunga J, Kmiec S, Jr., Yarlagadda P, Schuetz M. Quantification of cephalomedullary nail fit in the femur using 3D computer modelling: a comparison between 1.0 and 1.5m bow designs. Journal of orthopaedic surgery and research. 2016;11(1):53.

4. DePuy Synthes Test Data on File, Biomechanical Evaluation of Non-Augmented & Augmented TFNA Head Elements in Surrogate Femoral Heads. Windchill 0000268245.*

5. Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann M, Windolf M, Gueorguiev B. Biomechanical Effect of bone cement augmentation on the fixation strength of TNFA blades and screws. Presented at 22nd Congress of the European Society of Biomechanics. 10-13 July 106. Lyon, France.*

6. Kammerlander C, Gebhard F, Meier C, et al. Standardized cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicenter trial. Injury. 2011; 42 (12): 1484-1490.

7. Kammerlander C, Doshi H, Gebhard F, Scola A, Meier C, Linhart W, Garcia-Alonso M, Nistal J, Blauth M. (2014) Long-Term results of the augmented PFNA: a prospective multicenter trial. Arch Orthop Trauma Surg. 134(3):343-9.

8. Kammerlander C, Hem E, Klopfer T, Gebhard F, Sermon A, Dietrich M, Bach O, Weil Y, Babst R, Blauth M. Cement Augmentation of the Proximal Femoral Nail Antirotation (PFNA) – A Multicenter Randomized Controlled Trial. Injury. https://doi.org/10.1016/j.injury.2018.04.022.

9. Hofmann, L. AO Foundation: Final Report for biomechanics evaluation of a non-augmented nail head elements in surrogate female heads [Synthes GmbH:USTRA09022 Trochanteric Fixation Nail- Advanced (TFNA)]. 2015.*

10. DePuy Synthes Report: Static Cut Through Rotation Test in Bone Foam. 2016. Ref: 0000165855.*

11. Stoffel K, Zderic I, Gras F, Sommer C, Eberli U, Mueller D, Oswald M, Gueorguiev B. Biomechanical evaluation of the femoral neck system in unstable Pauwels III femoral neck fractures: a comparison with the dynamic hip screw and cannulated screws. J Orthop Trauma. 2017; 31(3):131-137.

12. B. J. L. Kendrick, H. A. Wilson, J. E. Lippett, A. R. McAndrew, A. J. M. D. Andrade. CORAIL uncemented hemiarthroplasty with a Cathcart head for intracapsular hip fractures. Bone Joint J 2013;95-B:1538-43.

13. TSM Report, CORAIL WW implantations YTD, 1986 – 2016.

14. TSM Report, PINNACLE WW implantations YTD, 2001 - 2016.

15. DePuy Synthes Trauma. Femoral Shaft Nailing Standard vs Recon (Primary market research, n=800), #0000265342, 2017

16. DePuy Synthes Trauma. Data on File. Analysis - Femoral Recon Nail, Proximal Nail End. 2017. Ref 0000271887.

17. DePuy Synthes Trauma- Data on File. Analysis - Anatomical Study. 2017. Ref 0000271671.

18. Kammerlander C, Kates SL, Wagner, M, Roth T, Blauth M. Minimially invasive periprosthetic plate osteosynthesis using the locking attachment plate. Oper Orthop Traumatol 2013; 25: 398-410.

19. Wagner M, Schutz M, Lorich D, Norris, B, Nork S, Kregor P. Trauma Lower Extremity: 3.5 Locking Attachment Plate. AOTK TK System Innovations. 2010 (1): 34-36.

20. Lenz M et al. The locking attachment plate for proximal fixation of periprosthetic femur fractures- a biomechanical comparison of two techniques. International Orthopedics (SICOT) (2012) 36:1915-1921.*

21. Dawson J, Kiner D, Gardner W, 2nd, Swafford R, Nowotarski PJ. The reamer-irrigator-aspirator as a device for harvesting bone graft compared with iliac crest bone graft: union rates and complications. J Orthop Trauma. 2014; 28(10):584--590.

22. Uppal HS, Peterson BE, Misfieldt ML, et al. The viability of cells obtained using the reamer-irrigator-aspirator system and in bone graft from the iliac crest. Bone Joint J. 2014; 95-B(9):1269-1274.

23. Henrich D, Seebach C, Sterlepper E, Tauchmann C, Marzi I, Frank J. RIA reamings and hip aspirate: a comparative evaluation of osteoprogenitor and endothelial progenitor cells. Injury. 2010; 41 Suppl 2:S62-68.

24. Sagi HC, Young ML, Gerstenfield L, Einhorn TA, Tornetta P. Qualitative and quantitative differences between bone graft obtained from the medullary canal (with a reamer/irrigator/aspirator) and the iliac crest of the same patient. J Bone Joint Surg Am. 2012; 94(23):2128-2135.

25. Cox G, Boxall SA, Giannoudis PV, et al. High abundance of CD271(+) multipotential stromal cells (MSCs) in intramedullary cavities of long bones. Bone. 2012; 50(2):510-517.

26. Toosi S, et al. Comparative characteristics of mesenchymal stem cells derived from reamer-irrigator-aspirator, iliac crest bone marrow, and adipose tissue. Cell Mol Biol. 2016; 62(10):68-74.

27. Belthur MV, Conway JD, Jindal G, Ranade A, Herzenberg JE. Bone graft harvest using a new intramedullary system. Clin Orthop Relat Res. 2008; 466(12): 2973-2980.

28. Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011;42-Suppl 2:S3-S15.

29. Higgins TF, Casey V, Bachus K. Cortical heat generation using an irrigating/aspirating single-pass reaming vs. conventional stepwise reaming. J Orthop Trauma. 2007;21(3):192-197.

30. Hall JA MM, Vicente MR, Morison ZA, Dehghan N, Kredar HJ, Petrisor B, Schemitsch E. A prospective randomized trial investigating the effect of the reamer-irrigator-aspirator (RIA) on the volume of embolic load and respiratory functions during intramedullary nailing of femoral shaft fractures. Orthopedic Trauma Association 2013 Annual Meeting; October 9-12, 2013; Phoenix AZ, USA.

31. Quintero A, Tarkin I, Pape H. Technical tricks when using the reamer irrigator aspirator technique for autologous bone graft harvesting. Journal of Orthopaedic Trauma. 2010; 24(1):42-45.

32. Goplen G, Wilson JA, McAffrey M, Deluzio K, Leighton R. A cadaver model evaluating femoral intramedullary reaming: a comparisonbetween new reamer design (Pressure Sentinel) and a novel suction/irrigation reamer (RIA). Injury. 2010; 41 Suppl 2:S38-42.

33. NICE. Hip Fracture Guideline. CG 124, https://www.nice.org.uk/guidance/cg124/resources. Retrieved from the worldwide web September 24, 2018.

34. American Association for Orthopedic Surgeons. Management of Hip Fractures in the Elderly, http://www.aaos.org/research/guidelines/HipFxGuideline.pdf. Retrieved from the worldwide web September 24, 2018.

35. Hage D and van Veen R. Using ‘LEAN Thinking’ when Implementing the Geriatric Fracture Program in the OLVG Hospital Amsterdam. Presented as a Poster at the 7th Annual Fragility Fracture Network Meeting. Dublin. July 5th to 8th. 2018.

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 32 720 40 60Fax: +41 32 720 66 00

www.depuysynthes.com

DePuy (Ireland)LoughbegRingaskiddyCo. CorkIrelandTel: +353 21 4914 000