exceeding the highest standards yours. - j&j medical … · femoral recon nail (frn) 3. 4 5...
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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.
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www.depuysynthes.com
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