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KNEE & HIP ARTHROPLASTY Procedural solutions to help surgeons improve patient satisfaction and surgical workflow

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Page 1: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

KNEE & HIP ARTHROPLASTY

Procedural solutions to help surgeons improve patient satisfaction and surgical workflow

Page 2: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

In a systematic retrospective review of all revision total knee arthroplasties [SHA] (TKAs) performed at a centre between 2003 and 2012 (n=781):• the most common reason overall for failure was loosening (39.9%)

• the second most common reason overall for failure was infection (27.4%), and infection was the most common reason in the early revision group, accounting for 37.6% of revisions performed <2 years after the primary procedure

• infection also accounted for 21.9% of revisions TKA in the late failure group

Orthopaedic joint replacement surgeries are among the most commonly performed procedures [DAT1,DAT2] With an aging population and increasing sports injuries, the number of procedures is expected to rise, presenting providers with the challenge of driving down costs.[DAT1,DAT2]

Complications, such as surgical site infections (SSIs), during these procedures can have a great economic impact due to additional hospital costs and extended hospital stays.[WHO]

Loosening, instability and infection are the most common causes of total knee and hip arthroplasty failure

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The Australian Orthopaedic Association National Joint Replacement Registry [AOANJRR] 2016 Annual Report includes detailed information on all revision hip procedures undertaken from September 1999 up to the end of 2015 (n = 11,907).• The most common reason for revision of primary total conventional hip replacement are loosening / lysis (27.6%), followed by prosthesis dislocation (23.5%) and fracture (18.7%)

• The fourth most common reason is infection (17.5%)

5.0%

4.0%

3.0%

2.0%

1.0%

0.0%0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Loosening/Lysis

Prosthesis Dislocation

Fracture

Infection

Pain

Years Since Primary Procedure

Total Conventional

Cu

mu

lati

ve In

cid

ence

Figure HT5 Cumulative Incidence Revision Diagnosis of Primary Total Conventional Hip Replacement

Note: All procedures using metal/metal prostheses with head size larger than 32mm have been excluded

Page 3: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

BURDEN OF SSIS IN HIP AND KNEE ARTHROPLASTY [BRU, CAR]

Length of stay (LOS) 2 to 3 fold increase

Re-admission rate 2 fold increase

Mortality 1.2% to 56% over 1 year

Hospital costs 3 fold increase

Patient quality of life Decreased

Infection decreases patient quality of life and represents a major clinical and economic burden in knee and hip arthroplasty[BRU, CAR]

• Staphylococcus aureus is one of the leading causes of SSIs [BRU]

— Hip arthroplasty (median SSI rate: 2.1%; range: 0.05% to 28%)

— Knee arthroplasty (median SSI rate: 1.3%; range: 0.05% to 19%)

— S. aureus accounted for 35% of all orthopaedic surgery SSIs, of which 35.7% were specifically attributed to MRSA infections.

Patel H, Khoury H, Girgenti D, Welner S, Yu H (2016) Burden of Surgical Site Infections Associated with Arthroplasty and the Contribution of Staphylococcus aureus. Surg Infect (Larchmt) 17 (1): 78-88. Whitehouse JD, Friedman ND, Kirkland KB, Richardson WJ, Sexton DJ (2002) The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality of life, excess length of stay, and extra cost. Infect Control Hosp Epidemiol 23 (4): 183-189.

Page 4: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

Johnson & Johnson Medical

Our goal: to be your partner of choice across the entire patient pathwayHelping improve clinical outcomes, patient experience and reduce cost

Page 5: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

CORAIL® PINNACLE® Total Hip System

CORAIL PINNACLE is the most widely used single company cementless construct in several registries including Australia and the UK [NJR, AOA]

Using a proven, robust construct design with a strong supportive evidence base can potentially help reduce revision risk and the associated cost burden.

The existing evidence highlights the excellent long-term stability and durability of the CORAIL stem and PINNACLE acetabular cup.

• There are over 152,000[SDOF] documented cases included on registries worldwide with recorded survivorship up to 97.19% and 95.1% at 10 years in UK and Australian registries, respectively [NJR, AOA]

• The CORAIL PINNACLE hip construct can be used in multiple indications as well as standard cases, including complex primary cases and fractured neck of femurs. [KEN,SCH, VID, HAL] CORAIL PINNACLE has also demonstrated successful performance in young and high demand patients. [WAN,GRE]

• CORAIL and PINNACLE have both been granted 10A* ratings by the Orthopedic Data Evaluation Panel (ODEP). [ODE]

• More than 1 million construct combinations (cup, liner, head, stem) available within the CORAIL PINNACLE family of products

The CORAIL hip system celebrated 30 years in 2016, and in that time has been provided to over

1,800,000 patients.

Over the last 15 years, the PINNACLE Acetabular Cup System has been provided to over

2,300,000 patients.

Intra operative solutions from exposure to closure

Johnson and Johnson knee and hip solutions to promote patient satisfaction and improve surgical workflow

ATTUNE® Knee System

An innovative, comprehensive, integrated knee system.

• Designed to address the clinical needs of patients, surgeons, and hospital providers around the world

• Extensive research and science included in the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers

• One of the largest research and development projects in the history of DePuy Synthes Joint Reconstruction, combining the latest in design, kinematics, engineering and materials to deliver stability and motion

FEATURES BENEFITS

ATTUNE GRADIUS™ CurveGradually reducing femoral radius designed to provide a smooth transition from stability to rotational freedom through a patient’s range of motion.

GLIDERIGHT™ ArticulationEncompasses a trochlear groove designed to accommodate patient variation and soft tissue interaction, and patellar components designed to optimise patellar tracking while maintaining bore coverage.

SOFCAM™ ContactDesigned to provide a smooth engagement for gradual femoral rollback and stability in flexion, while reducing stresses transferred to the tibial spine.

LOGICLOCK™ Tibial Base Patented central locking design provides the architecture for the system that optimises kinematics, while reducing backside micromotion to one of the lowest reported levels in the industry. [LEI]

intuition™ INSTRUMENTSCombines the surgical process with intuitive and efficient instruments to allow the surgeon to balance the soft tissue and precisely control the implant position and fit for each patient.

COMBINATION IMPLANTATIONS YEAR 3 YEAR 5 YEAR 10

CoC 35,092 1.78% (1.64% - 1.94%) 2.38% (2.20% - 2.57%) 4.00% (3.38% -4.74%)

CoP 16,320 1.26% (1.07% - 1.48%) 1.90% (1.61% - 2.24%) 2.81% (2.13% - 3.72%)

MoP 42,469 1.42% (1.30% - 1.55%) 1.77% (1.62% - 1.93% 3.16% (2.72% - 3.66%)

Italics signify <250 cases remained at risk at these timepoints [NJR]

Page 6: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

STRATAFIX™ Knotless Tissue Control Device Portfolio

Ethicon STRATAFIX™ Knotless Tissue Control Devices are available in a variety of different anchor technologies that can be used to close incisions in organs, fascia,* and skin.

TISSUE TYPE REQUIRED HOLDING STRENGTH POTENTIAL SOLUTIONS

References 1. Leaper DJ, van Goor H, Reilly J, et al. Surgical site infection – a European perspective of incidence and economic burden. Int Wound J. 2004;1(4): 247-273. 2. Global guidelines on the prevention of surgical site infection. World Health Organization; 2016. Available from http://www.who.int/gpsc/ssi-guidelines/en/. Accessed 08 Nov 2016. 3. Barbolt TA. Chemistry and safety of triclosan, and its use as an antimicrobial coating on Coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 suture with triclosan). Surg Infect (Larchmt). 2002;3 (suppl):S45-S53. 4. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobial evaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt). 2002;3 (suppl):S79-S87. 5. Ming X, Rothenburger S, Yang D. In vitro antibacterial e�icacy of Monocryl Plus Antibacterial Suture (poligelcaprone 25 with triclosan). Surg Infect (Larchmt). 2007;8(2):201-207. 6. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial e�icacy of PDS Plus (polidioxanone with triclosan) sutre. Surg Infect (Larchmt). 2008;9(4):451-457.

Additional costof an SSI can be

€2000 to€40001

Take Greater Controlof key risk factors related to Surgical Site Infections (SSIs) Suture selection provides an important opportunity to address a known risk factor for infection — bacterial colonization of the suture.

*Trademark of BASF SE.

Ethicon Plus Suture facts

The small amount of triclosan used in Plus Sutures does not accumulate in the body and is metabolized and excreted in a neutralized form.3

Triclosan used in Plus Sutures — IRGACARE® MP*— is the purest form available,

shown in vitro to inhibit bacterial colonization of the suture for days or more.3-6

Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

using 2

Ethicon Plus Antibacterial Sutures are the only sutures with triclosan available worldwide.

The petri dish image is for illustrative purposes only,zone of inhibition testing results can vary.

SSIs are common & costly for patients and hospitals

NEWS

Now supported by a World Health Organization (WHO) Guideline:The panel suggests the use of triclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery.2

The third party trademarks used herein are the trademarks of their respective owners.

wwww.ethicon.com

Ethicon Endo-Surgery (Europe) GmbH

Hummelsbütteler Steindamm 71

22851 Norderstedt, Germany

© Ethicon Endo-Surgery (Europe) GmbH 2016, 062812-161115 EMEA

7

References 1. Leaper DJ, van Goor H, Reilly J, et al. Surgical site infection – a European perspective of incidence and economic burden. Int Wound J. 2004;1(4): 247-273. 2. Global guidelines on the prevention of surgical site infection. World Health Organization; 2016. Available from http://www.who.int/gpsc/ssi-guidelines/en/. Accessed 08 Nov 2016. 3. Barbolt TA. Chemistry and safety of triclosan, and its use as an antimicrobial coating on Coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 suture with triclosan). Surg Infect (Larchmt). 2002;3 (suppl):S45-S53. 4. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobial evaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt). 2002;3 (suppl):S79-S87. 5. Ming X, Rothenburger S, Yang D. In vitro antibacterial e�icacy of Monocryl Plus Antibacterial Suture (poligelcaprone 25 with triclosan). Surg Infect (Larchmt). 2007;8(2):201-207. 6. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial e�icacy of PDS Plus (polidioxanone with triclosan) sutre. Surg Infect (Larchmt). 2008;9(4):451-457.

Additional costof an SSI can be

€2000 to€40001

Take Greater Controlof key risk factors related to Surgical Site Infections (SSIs) Suture selection provides an important opportunity to address a known risk factor for infection — bacterial colonization of the suture.

*Trademark of BASF SE.

Ethicon Plus Suture facts

The small amount of triclosan used in Plus Sutures does not accumulate in the body and is metabolized and excreted in a neutralized form.3

Triclosan used in Plus Sutures — IRGACARE® MP*— is the purest form available,

shown in vitro to inhibit bacterial colonization of the suture for days or more.3-6

Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

using 2

Ethicon Plus Antibacterial Sutures are the only sutures with triclosan available worldwide.

The petri dish image is for illustrative purposes only,zone of inhibition testing results can vary.

SSIs are common & costly for patients and hospitals

NEWS

Now supported by a World Health Organization (WHO) Guideline:The panel suggests the use of triclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery.2

The third party trademarks used herein are the trademarks of their respective owners.

wwww.ethicon.com

Ethicon Endo-Surgery (Europe) GmbH

Hummelsbütteler Steindamm 71

22851 Norderstedt, Germany

© Ethicon Endo-Surgery (Europe) GmbH 2016, 062812-161115 EMEA

7Capsule > 3 weeks • •Subcutaneous > 3 weeks •Sub-cuticular 1 to 2 weeks •

*STRATAFIX™ Symmetric PDS™ Plus Devices only

Strength and security: interrupted suturing without knot-related complications [DAT3]

• Anchors run along length of devices to provide secure fixation with every pass

• In preclinical studies, cutting the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device or the

STRATAFIX™ Spiral Knotless Tissue Control Device in a bidirectional design did not result in tissue separation [DAT4]

More consistent tension control and approximation during closure [MOR]

• Unique anchor design delivers multiple points of fixation to help maintain approximation along the suture line during closure

• Compared to traditional sutures, the devices help surgeons to easily

manage tension and control approximation during closure

More efficient than continuous suturing [DAT5]

• Anchors lock into place after each pass, eliminating the need to have an assistant follow the suture

• With equal strength and security, the devices can close wounds substantially faster than use of an interrupted technique [DAT5]

Triclosan-coated sutures can reduce the risk of SSI2016 WHO Global Guidelines for the prevention of SSI suggest the use of Triclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery**

** “Conditional” recommendation with “moderate” quality of evidence

STRATAFIX™ Knotless Tissue Control Devices with IRGACARE® MP (triclosan) - the only commercially available knotless tissue control devices with antibacterial protection.

[Petri dishes displaying zone of inhibition for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device] 11 days for E. coli and 23 days for S. aureus (in vitro)

Page 7: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

* In an ex vivo study, more load in N was required to create a 3-mm gap between skin edges approximated with DERMABOND® PRINEO® System than with

subcuticular 4-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo-Surgery skin staples (P<.001).

• 33% stronger when compared to the average strength of staples

• 40% stronger when compared to the average strength of 4-0 suture

Mea

n m

ax lo

ad (N

) p

rio

r to

3 m

m g

ap (+

/- 1

mm

)

200

175

150

125

100

75

50

25

0Skin Staples 4-0 Subcuticular

SutureDERMABOND® PRINEO®

Skin Closure System (22 cm)

166.53 112.4 98.69

Comparative skin–holding strengths

DERMABOND® PRINEO® System

The only skin closure device to combine a topical skin adhesive with a self-adhering mesh• The 22cm system uses 2 unique components allowing for uncompromising strength and wound healing [DAT6]

— Liquid topical skin adhesive (2-octyl cyanoacrylate) formulation sets in ~60 seconds when applied to mesh [DAT6]

— Flexible self-adhesive polyester mesh accelerates polymerisation of liquid adhesive and conforms to body’s contours [DAT6]

Skin-holding strength superior to staples or subcuticular suture (P<.001) [DAT6]*

MRSE = Methicillin-resistant Staphylococcus epidermidis

Patient quality of life benefits

• Promotes self-care – no post-surgical dressing changes required [VAN, DEC]

• Ability to shower immediately after procedure (subject to their healthcare professionals recommendation) [DAT6]

• Easy mesh tape removal when wound is sufficiently healed [DAT7]

• Less pain on removal versus other wound closure methods [PAR, BLO, RIC]

• Good cosmetic results [PAR, BLO, RIC]

Proven 99% effective through 72 hours in vitro against bacteria most commonly associated with SSIs, including S. aureus, P. aeruginosa, E. coli, E. faecium, and S. epidermidis (including MRSA and MRSE).* [ETH, DAT5]

Page 8: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

Improving post-operative outcomesCare4Today® Orthopedics Solution

CORAIL® PINNACLE® Total Hip System: • Demonstrated by patient-reported outcomes in NJR 2003-2015 to reduce hip self-reported problems 6 months after surgery in 88.6% of patients and provide excellent or very good satisfaction in 79.1% of patients (vs 85.6% and 73.5% of all primary hips, respectively) [LEO]

STRATAFIX™:• Triclosan-coated sutures have been shown in multiple meta-analysis to reduce the risk of SSIs by 26-28% [AEA]

DERMABOND® PRINEO® System:• New Premier data showing 12% reduction in LOS with Prineo22 and 31% reduction in discharge to non home setting [DAT8]

ATTUNE® Knee System:

• One-year results from two worldwide studies showed improved patient reported outcomes with the ATTUNE knee compared to other leading knee systems [HWG]

What is Care4Today® Orthopedic Solutions? • Care4Today Orthopedic Solutions is a technology-enabled, end-to-end Patient Pathway program for patients undergoing elective surgery for total hip and knee surgery. The solution is built around 3 fundamental pillars:

— Empower patients to take control of their own treatment and recovery

— Drive consistency between the Multi-disciplinary team across the entire pathway based on Enhanced Recovery principles

— Provide continuity of care (in and out of the hospital setting) throughout the patient journey.

Why Care4Today? • Care4Today Orthopedic Solutions is a proven solution with a track record of success. This solution has shown improved clinical outcomes, improved patient experience at a reduced cost.

• In a service evaluation with over 2000 patients, Care4Today Orthopedic solutions showed: [ISPOR]

— Statistically significant reduction in Length of Stay

— Improvement in Patient Reported Outcome Measures

— Improvement in Patient experience in 5 domains: satisfaction, education, confidence, expectation, and recommendation

— Cost Savings of approximately £250K per annum [ISPOR]

• Care4Today aims to deliver clinical and cost-effective care in hip and knee arthroplasty. Shorter durations of inpatient stay without a negative impact on clinical outcomes, improved patient-focused outcomes and experience, can deliver significant value, especially benefiting those with greater medical complexity and need.

Page 9: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

Subcutaneous/Fat

Polymer Needle Size* Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Skin

Product code Description Mesh length EA/BX

CLR222-octylcyanoacrylate topical skin adhesive applicator, flexible, self-adhesive polyester mesh tape dispenser

22 cm 2

The Johnson & Johnson range of knee and hip procedural solutions: Designed to promote patient satisfaction and improve surgical workflow

*Sizing shown represents tensile strength.

DERMABOND® PRINEO® System

Potential STRATAFIX™ Device Needle Type

CORAIL® PINNACLE® Total Hip System For more information visit emea.depuysynthes.com/hcp/hip

ATTUNE® Knee System For more information visit emea.depuysynthes.com/hcp/knee

Subcuticular / Deep Dermal

Polymer NeedleSize*

Length (cm)

4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL™

Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL™

Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Capsule

Polymer NeedleSize*

Length (cm)

4-0 3-0 2-0 0 1 Color

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

14 x 1424 x 2436 x 36

SXPD2B408SXPD2B412

SXPD2B409SXPD2B410 Dyed

Spiral PDOCT-1, 36 mm, 1/2 Circle Taper Point

2030

SXPD1B400SXPD1B401

Dyed

Spiral PDOCT-1, 36 mm, 1/2 Circle Taper Point

14 x 1424 x 24

SXPD2B401SXPD2B402

Dyed

Spiral PDOOS-6, 36 mm, 1/2 CircleReverse Cutting

24 x 2430 x 30

SXPD2B200SXPD2B201

Dyed

Symmetric PDS™ Plus

CT-1, 36 mm, 1/2 CircleTaper Point

45 SXPP1A403 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS™ Plus

CT, 40 mm, 1/2 CircleTaper Point

45 SXPP1A406 SXPP1A405 Dyed

Spiral PDS™ PlusCT-1, 36 mm, 1/2 CircleTaper Point

1530

SXPP1B409SXPP1B410

SXPP1B406SXPP1B450

Dyed

Page 10: Procedural solutions to help surgeons improve patient ...€¦ · ATTUNE® Knee System An innovative, comprehensive, integrated knee system. • Designed to address the clinical needs

References: [DAT1] Data on file. Ethicon, Inc. Knee Procedure Volume 2016. [DAT2] Data on file. Ethicon, Inc. Hip Procedure Volume 2016. [WHO] WHO Guidelines for Safe Surgery 2009. Geneva, Switzerland: World Health Organization; 2009. [SHA] Sharkey PF, et al, Why Are Total Knee Arthroplasties Failing Today - Has Anything Changed After 10 Years?, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2013.07.024 [AOANJRR] Australian Orthopaedic Association National Joint Replacement Registry Hip Knee & Shoulder Arthroplasty Annual Report 2016. Available at: https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty Accessed February 2017. [BRU] Bruns TB, Robinson BS et al. A new tissue adhesive for laceration repair in children. J Pediatr. 1998;132(6):1067-1070. [CAR] Carleo C, Singer AJ, Thode HC Jr. Effect of frequent water immersion on the rate of tissue adhesive sloughing: a randomized study. CJEM. 2005;7(6):391-395. [ULR] Ulrich SD, et al, Total hip arthroplasties: What are the reasons for revision? International Orthopaedics (SICOT) (2008) 32:597–604. [LAC] Lachiewicz PF, Soileau ES (2005) Changing indications for revision total hip arthroplasty. J Surg Orthop Adv 14(2):82–84. [CLO] Clohisy JC, Calvert G, Tull F et al (2004). Reasons for revision hip surgery: a retrospective review. Clin Orthop Relat Res (429):188–192. [WEE] Weeden SH, Paprosky WG (2002) Minimal 11-year follow-up of extensively porous-coated stems in femoral revision total hip arthroplasty. J Arthroplasty 17[4 Suppl 1]:134–137. [LIN] Lind M, Krarup N, Mikkelsen S et al (2002). Exchange impaction allografting for femoral revision hip arthroplasty: results in 87 cases after 3.6 years’ follow-up. J Arthroplasty 17(2):158–164. [ULL] Ullmark G, Hallin G, Nilsson O (2002) Impacted corticocancellous allografts and cement for revision of the femur component in total hip arthroplasty. J Arthroplasty 17(2):140–149. [BOH] Bohm P, Bischel O (2001) Femoral revision with the Wagner SL revision stem: evaluation of one hundred and twenty-nine revisions followed for a mean of 4.8 years. J Bone Jnt Surg Am 83-A(7):1023–1031. [TEM] Templeton JE, Callaghan JJ, Goetz DD et al (2001). Revision of a cemented acetabular component to a cementless acetabular component. A ten to fourteen-year follow-up study. J Bone Jnt Surg Am 83-A(11):1706–1711. [CRA] Crawford SA, Siney PD, Wroblewski BM (2000) Revision of failed total hip arthroplasty with a proximal femoral modular cemented stem. J Bone Jnt Surg Br 82(5):684–688. [BRU] Bruns TB, Robinson BS et al. A new tissue adhesive for laceration repair in children. J Pediatr. 1998;132(6):1067-1070. [CAR] Carleo C, Singer AJ, Thode HC Jr. Effect of frequent water immersion on the rate of tissue adhesive sloughing: a randomized study. CJEM. 2005;7(6):391-395. [STR] Strauss EJ, Weil WM et al. A Prospective, Randomized, Controlled Trial of 2-Octylcyanoacrylate Versus Suture Repair for Nail Bed Injuries. J Hand Surg Am. 2008;33(2):250-253. [SUN] Sun J, Chen Q-M et al. Octylcyanoacrylate versus absorbable suture in the repair of skin wound in children. Chinese J Clin Rehabilitation. 2005;19:26-29 [SWI] Switzer EF, Dinsmore RC et al. Subcuticular closure versus dermabond: A prospective randomized trial. Am Surg. 2003;69(5):434-436. [DAT3] Control Devices vs Various Products. Data on File. May 2015. DOF/AST-2013-0056/p3/Conclusion. [VAK] Vakil JJ, O’Reilly MP et al. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713. [MOR] Moran ME, Marsh C et al. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178. [LEV] Levine BR, Ting N et al. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. [EIC] Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. [EIN] Einarsson JI, Chavan NR et al. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95. [ROD] Rodeheaver GT, Pineros-Fernandez A et al. Barbed sutures for wound closure: in vivo wound security, tissue compatibility and cosmesis measurements. In: Transactions from the 30th Annual Meeting of the Society for Biomaterials; Mount Laurel, NJ; 2005. p. 232. [WAR] Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225. [DAT4] Ethicon, AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. Data on File. Aug 2012. DOF/AST-2012-0331/p4/para13/lines1-2; p5/para1/lines1-2 [MOR] Moran2007/p1176/col2/para2. [DAT5] Ethicon, 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. Data on File. May 2015. DOF/100326296/p8/Conclusion. [DAT6] Data on File, Ethicon Inc. (2013) DERMABOND® PRINEO® Skin Closure System Matrix. PRI-044-13. [PAR] Parvizi D, Friedl H et al (2013). Use of 2-octyl cyanoacrylate together with a self-adhering mesh (Dermabond Prineo) for skin closure following abdominoplasty: an open, prospective, controlled, randomized, clinical study. Aesthetic Plast Surg 37 (3): 529-537. [BLO] Blondeel PN, Richter D et al (2014). Evaluation of a new skin closure device in surgical incisions associated with breast procedures. Ann Plast Surg 73 (6): 631-637. [SIN] Singer AJ, Chale S et al (2011). Evaluation of a novel wound closure device: a multicenter randomized controlled trial. Acad Emerg Med 18 (10): 1060-1064. [RIC] Richter D, Stoff A et al (2012). A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. Plast Reconstr Surg 130 (4): 843-850. [KHA] Khan RJ, Fick D et al (2006). A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br 88 (2): 238-242. [EGG] Eggers MD, Fang L et al (2011). A comparison of wound closure techniques for total knee arthroplasty. J Arthroplasty 26 (8): 1251-1258 e1251-1254. [ELG] El-Gazzar Y, Smith DC et al (2013). The use of dermabond(R) as an adjunct to wound closure after total knee arthroplasty: examining immediate post-operative wound drainage. J Arthroplasty 28 (4): 553-556. [SID] Siddiqui M, Bidaye A et al (2016). Wound dressing following primary total hip arthroplasty: a prospective randomised controlled trial. J Wound Care 25 (1): 40, 42-45. [VAN] van Nooten F, De Cock E et al (2008). Comparing time and supplies usage associated with a new skin closure device vs. standard of care wound closure for abdominoplasty surgery in The Netherlands. International Society for Pharmacoeconomics and Outcomes Research, 11th Annual European Congress. Athens, Greece. [DEC] De Cock E, van Nooten F et al (2008). Changing the surgical wound closure management pathway: Time and supplies with PRINEO™ vs. standard of care for abdominoplasty surgery in Germany. International Society for Pharmacoeconomics and Outcomes Research, 11th Annual European Congress. Athens, Greece. [DAT7] Data on File, Ethicon Inc. (2007) Dirk Richter Letter “Easily removed”. 05/21/2007. [COR] CORAIL Unit Sales 2015. DePuy Orthopedics, Inc. [LEI] Leisinger S, Hazebrouck S et al (2011). Advanced Fixed Bearing TKA Locking Mechanism Minimizes Backside Micromotion. International Society for Technology in Arthroplasty (ISTA) Annual Meeting. [NJR] National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 13th Annual Report, 2016. Table 3.9. Available from www.njrreports.org.uk. [AOA] Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2016. Available from URL: https:// aoanjrr.sahmri.com/annual-reports-2016. Extract from Table TY1. Table TY1 Cumulative Percent Revision of Primary Total Conventional Hip Replacement Combinations with 10 Year Data (Primary Diagnosis OA). [SDOF] 1986 - 2015 sales data on file, DePuy International Ltd. [KEN] Kendrick BJ1, Wilson HA et al. CORAIL uncemented hemiarthroplasty with a Cathcart head for intracapsular hip fractures Bone Joint J. 2013 Nov;95-B(11):1538-43. [SCH] Schaller G, Black J et al. Primary Collared Uncemented Total Hip Arthroplasties in the Elderly: A Safe and Reliable Treatment Option. The Journal of Arthroplasty 30 (2015) 407–410. [VID] Vidalain JP - The CORAIL Hip System: A Pratical approach based on 25 years of experience. 2011;Chapter 4.2.1:94-101. [HAL] Hallan G, Lie SA et al. Medium and long-term performance of 11,516 un-cemented primary femoral stems from the Norwegian arthroplasty register. Journal of Bone and Joint Surgery, 2007;89-B:1574-1580 and cross-linked polyethylene at minimum 10-year follow-up. J Arthroplasty. 2014 Oct;29(10):1961-9. [WAN] Wangen H1, Lereim P et al. Hip arthroplasty in patients younger than 30 years: excellent ten to 16-year follow-up results with a HA-coated stem. Int Orthop. 2008 Apr;32(2):203-8. [GRE] Greiner JJ, Callaghan JJ et al. Fixation and Wear With Contemporary Acetabular Components and Cross-Linked Polyethylene at 10-Years in Patients Aged 50 and Under. J Arthroplasty. 2015 Sep; 30(9):1577-85. [ODE] Orthopedic Data Evaluation Panel (ODEP) Available at: www.odep.org.uk. [ISPOR] 19th Annual European Congress, 29 October – 2 November 2016, Austria Center Vienna, Austria, Abstract No. 68130. [HWG] Hamilton WG, Brenkel I et al. Early Patient-Reported Outcomes With Primary vs Contemporary Total Knee Arthroplasty: A Comparison of Two Worldwide Multi-Center Prospective Studies. Presentation at the International Society for Technology in Arthroplasty (ISTA), Boston, MA Oct. 2016. Poster Presentation & E-Poster 0060. [LEO] Leopold J.: PATIENT REPORTED OUTCOME MEASURES OF THE CORAIL/PINNACLE CONSTRUCT; NJR-NJR data from 1st April 2003 -10th July 2015 on DePuy products supplied for post-marketing surveillance, NJR Centre, 2015. [DAT8] Total Knee Arthroplasty Knee Procedures DERMABOND PRINEO Skin Closure System vs. Skin staples showed statistically significantly reduced length of stay (p<0.05). Data on File. Ethicon, Inc. 2. Total Knee Arthroplasty Knee Procedures DERMABOND PRINEO Skin Closure System vs. Skin staples showed statistically significantly reduced discharge rates(p<0.05). Data on File. Ethicon, Inc. 3. Total Knee Arthroplasty Knee Procedures DERMABOND PRINEO Skin Closure System vs. Skin staples showed statistically significantly reduced All-cause Readmission Rates at 30, 60, and 90 days. (p<0.05). Data on File. Ethicon, Inc. 4. Retrospective study using data from the Premier Inpatient Database, in Total Knee Arthroplasty procedures. N=1,942. [AEA] Apisarnthanarak et al. Triclosan-coated sutures reduce the risk of surgical site infections: a systematic review and meta-analysis. Infection Control & Hospital Epidemiology. 2015;36(2):169-179

For more information, contact your Ethicon or DePuy Synthes representative. Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

Please always refer to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

Ethicon, Johnson & Johnson Medical Limited, PO Box 1988, Simpson Parkway, Kirkton Campus Livingston, Scotland EH54 0AB, Registered in Scotland, No SC 132162 www.ethicon.com

©2017 Ethicon Endo-Surgery (Europe) GmbH. 053607-160522 EMEA

†Labeled as Ger PS-1.

Subcutaneous/Fat

Polymer Needle Size* Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral MONOCRYL™ Plus

SH, 26 mm, 1/2 CircleTaper Point

20 SXMP1B409 Undyed

Spiral MONOCRYL™ Plus

CT-1, 36 mm, 1/2 CircleTaper Point

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL™ Plus

CT-2, 26 mm, 1/2 CircleTaper Point

45 SXMP1B417 Undyed

Spiral PDS™ PlusCT-1, 36 mm, 1/2 CircleTaper Point

4570

SXPP1B411SXPP1B412

Dyed

Spiral PDS™ PlusSH, 26 mm, 1/2 CircleTaper Point

3070

SXPP1B416SXPP1B417

Dyed

Symmetric PDS™ Plus

CT-1, 36 mm, 1/2 CircleTaper Point

45 SXPP1A403 Dyed