Cementing better outcomes - Corporate · PDF fileCementing better outcomes. The challenge ......

Cementing better outcomes

The challengeOrthopaedic surgeons are demanding a simpler and superior bone cement solution for implant placement procedures. Surgeons need a bone cement portfolio with the necessary versatile options to handle a variety of cases, and a reliable consistency of bone cement and mixing options leading to an increasingly easy application and even cement bonding to implant and bone.

The solutionRALLY™ Bone CementPerfect implant placement takes precision and care. RALLY Bone Cement and Accessories is a diverse portfolio of bone cement and accessory options designed to offer peace of mind for the long road ahead. When you need a simple, comprehensive solution in the operating room, RALLY Bone Cement delivers industry-leading components engineered for easier administration and smoother cases. The portfolio includes the comprehensive femoral preparation kit, the cement restrictor, the VORTEX™ Vacuum Mixing System and a variety of specialty nozzles.

The following products work together or independently to make faster, easier surgery a reality.

Compressive Strength MPa

Flexural Strength MPa

Com

pres

sive

Str

engt

h (M

Pa)

AB B

B120

100

80

60

40

20

0

RALLY HV

Bars that do not share the same letter are statistically different.

Palacos R RALLY MV Simplex P

Flex

ural

Str

engt

h (M

Pa)

80

70

60

50

40

30

20

10

0RALLY HV Palacos R RALLY MV Simplex P

AB

AA


RALLY™ Bone Cement offers surgeons more flexibility and confidence in the operating room

Options for each surgeon’s needs• High viscosity• Medium viscosity• With Gentamicin• Without Gentamicin - All-in-One Sytem

Reliability: Long-lasting properties• Statistically higher compressive and bending strengths than Palacos® R • Long fatigue life and low porosity, even with hand-mixing2

Visibility: Long-lasting appearance• Spearmint green color from pigments for visibility• Barium sulphate for radiopacity

Consistency: Long-lasting ease of use• Easy-to-mix, whether hand or vacuum mixing• Smooth consistency from initial mixing to final implantation• Unique All-in-One vacuum mixing device - 70g of cement components pre-loaded in a mixing and dispensing device

Mechanical properties2

Compressive Strength MPa

Shear Strength MPa

Flexural Strength MPa

Flexural Modulus MPa

Com

pres

sive

Str

engt

h (M

Pa)

AB B

B120

100

80

60

40

20

0

RALLY HV


Palacos R RALLY MV Simplex P

Shea

r Str

engt

h (M

Pa)

50

40

30

20

10


There are no statistical differences between these results.

Flex

ural

Str

engt

h (M

Pa)

80

70

60

50

40

30

20

10


AB

AA


Flex

ural

Mod

ulus

(MPa

) 3000

2500

2000

1500

1000

500

0

RALLY HV Palacos R RALLY MV Simplex P

AB B A,B


Mechanical properties2

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

77.0

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

Tem

pera

ture

(°F)

77.0

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Setting time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Setting time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Mixing Phase

Dough Phase

Working Phase

Setting Phase

RALLY HV Bone Cement

RALLY MV Bone Cement

RALLY HV AB All-in-One System

Above All-in-One Systems were not mixed under vacuum.

Above bone cements were hand mixed.

RALLY HV AB Bone Cement

RALLY MV AB Bone Cement

RALLY MV AB All-in-One System

Time vs temperature characteristics1

Time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

Tem

pera

ture

(°F)

77.0

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Setting time (min)

10 2 43 5 6 7 8 9 10 1211 13 14 15 16 17 18 19 20

75.0

73.0

71.0

69.0

67.0

65.0

63.0

Tem

pera

ture

(°F)

Mixing Phase

Dough Phase

Working Phase

Setting Phase

Time vs temperature characteristics1

POWERPULSE Lavage System minimizes both contaminated waste and disposal costs.

BUCK Cement Restrictor is the Gold Standard in cement restrictors.

PREP-IM KIT sets the standard in femoral preparation kits.

Case preparation Prep-IM™ Total Hip Preparation Kit The Prep-IM Kit sets the standard in femoral preparation kits. It comes complete with the necessary tools and implants to clean the osteotomized femur and plug the intramedullary canal.

Includes the following:• 2 BUCK™ Cement Restrictors• 1 Femoral Canal Brush• 1 BUCK Disposable Inserter• 1 Femoral Canal Suction Absorber• 2 CONCISE™ Cement Sculps• 1 Medium Femoral Pressurizer

POWERPULSE™ Lavage SystemWith a variable-speed trigger for greater control, the POWERPULSE system utilizes flexible spray stems and fracture resistant suction tips to reduce intraoperative breakage. The unique design of the special suction canal allows debris to easily pass through the system without clogging. The reusable handpiece and power hose minimize both contaminated waste and disposal costs. The lavage system utilizes nitrogen or compressed-air sources which eliminate the need for battery packs or special pumps.

BUCK™ Cement RestrictorThe BUCK Cement Restrictor plugs the intramedullary canal and provides complete cement support of the femoral prosthesis. Both 18.5 and 25mm are part of the Prep-IM™ Kit, but 13, 30 and 35mm are available individually for more options.

POWERPULSE Lavage System minimizes both contaminated waste and disposal costs.

BUCK Cement Restrictor is the Gold Standard in cement restrictors.

POWERPULSE™ Lavage SystemWith a variable-speed trigger for greater control, the POWERPULSE system utilizes flexible spray stems and fracture resistant suction tips to reduce intraoperative breakage. The unique design of the special suction canal allows debris to easily pass through the system without clogging. The reusable handpiece and power hose minimize both contaminated waste and disposal costs. The lavage system utilizes nitrogen or compressed-air sources which eliminate the need for battery packs or special pumps.

BUCK™ Cement RestrictorThe BUCK Cement Restrictor plugs the intramedullary canal and provides complete cement support of the femoral prosthesis. Both 18.5 and 25mm are part of the Prep-IM™ Kit, but 13, 30 and 35mm are available individually for more options.

The VORTEX Vacuum Mixer saves time and effort in the OR.

Cement, cement mixing and delivery RALLY™RALLY HV and MV are optimized for joint replacement surgery by offering what is needed in a cement-reliability, visibility, and consistency. Both viscosities of RALLY possess strong mechanical properties, a spearmint green color for easy visibility, and smooth, doughy consistencies for easy clean-up. RALLY HV and MV have a long working time, but short setting time to reducing surgical idle time at the end of the surgery1. For convenience, RALLY MV and RALLY HV are both available in gentamicin antibiotic versions.

VERSABOND™VERSABOND cement is optimized for use in shoulder, hip and knee surgery. It can be vacuum-mixed or hand-mixed, injected or hand-packed for more intraoperative options. VERSABOND cement allows for less implant migration and has less porosity than other cements, thereby minimizing the chance of possible fatigue fractures. Furthermore, VERSABOND is conveniently available in both antibiotic (gentamicin) and non-antibiotic versions.

VORTEX™ Vacuum MixerWith three revolutions per crank, the preassembled VORTEX mixer saves time and effort in the OR. The VORTEX mixer’s angled base delivers a more consistent cement mix every time, and its large volume cylinder allows up to 120 grams of cement to be mixed at one time. An enclosed charcoal filter reduces the amount of monomer fumes released into the room.

Sterile, disposable mixer components mean faster, easier use. Mixing directly in the syringe eliminates the need for cement transfer. Plus the transparent top enables viewing the cement while it is being mixed. If a second batch is needed, the VORTEX mixer has a Re-Use Kit allowing the disposable inner components to easily be replaced with new components without opening a whole new mixer.

VORTEX Vacuum BowlFor knees, the unique VORTEX Vacuum Bowl functions as efficiently as the VORTEX mixer. It includes a spatula and the same time-saving, energy-reducing crank that turns out three revolutions for every one turn of the handle. That means less work, less air bubbles and the ability to mix high viscosity cements.

RALLY All-in-OneIn one unique device, the RALLY All-in-One provides a completely contained cementing solution. The device houses 70 grams of antibiotic RALLY HV or RALLY MV cement components for a completely isolated cementing procedure. Once the monomer is released into the powder chamber, the cement is easily mixed under vacuum, if necessary, and dispensed without ever exposing the cement to open air.

The All-in-One device simplifies the cementing process with fewer cementing components and fewer moving parts. RALLY All-in-One is ideal for total joint replacements typically using just less than 2 boxes of cement in a syringe application.

VORTEX NozzlesA Standard Breakaway Nozzle is included with the RALLY All-in-One device and the VORTEX Vacuum Mixing System, but for other needs, a variety of specialty nozzles are available including a Long Tapered Nozzle for radial impaction grafting, a long and flexible Revision Nozzle for revision hip surgery, an Angled Nozzle to deliver cement to the tibia during total knee arthroplasty and an Umbrella Interfacer to clean and pressurize the femoral canal.

RALLY and VORTEX GunsThe RALLY and VORTEX guns offer steady, pressurized delivery of cement.

PressurizersOne Medium Femoral Pressurizer is included in the Prep-IM™ Total Hip Preparation Kit that has been shown necessary for better femoral canal filling and reduction of voids in the cement mantle.3,4

Cement, cement mixing and delivery RALLY™RALLY HV and MV are optimized for joint replacement surgery by offering what is needed in a cement-reliability, visibility, and consistency. Both viscosities of RALLY possess strong mechanical properties, a spearmint green color for easy visibility, and smooth, doughy consistencies for easy clean-up. RALLY HV and MV have a long working time, but short setting time to reducing surgical idle time at the end of the surgery1. For convenience, RALLY MV and RALLY HV are both available in gentamicin antibiotic versions.

VERSABOND™VERSABOND cement is optimized for use in shoulder, hip and knee surgery. It can be vacuum-mixed or hand-mixed, injected or hand-packed for more intraoperative options. VERSABOND cement allows for less implant migration and has less porosity than other cements, thereby minimizing the chance of possible fatigue fractures. Furthermore, VERSABOND is conveniently available in both antibiotic (gentamicin) and non-antibiotic versions.

VORTEX™ Vacuum MixerWith three revolutions per crank, the preassembled VORTEX mixer saves time and effort in the OR. The VORTEX mixer’s angled base delivers a more consistent cement mix every time, and its large volume cylinder allows up to 120 grams of cement to be mixed at one time. An enclosed charcoal filter reduces the amount of monomer fumes released into the room.

Sterile, disposable mixer components mean faster, easier use. Mixing directly in the syringe eliminates the need for cement transfer. Plus the transparent top enables viewing the cement while it is being mixed. If a second batch is needed, the VORTEX mixer has a Re-Use Kit allowing the disposable inner components to easily be replaced with new components without opening a whole new mixer.

VORTEX Vacuum BowlFor knees, the unique VORTEX Vacuum Bowl functions as efficiently as the VORTEX mixer. It includes a spatula and the same time-saving, energy-reducing crank that turns out three revolutions for every one turn of the handle. That means less work, less air bubbles and the ability to mix high viscosity cements.

RALLY All-in-OneIn one unique device, the RALLY All-in-One provides a completely contained cementing solution. The device houses 70 grams of antibiotic RALLY HV or RALLY MV cement components for a completely isolated cementing procedure. Once the monomer is released into the powder chamber, the cement is easily mixed under vacuum, if necessary, and dispensed without ever exposing the cement to open air.

The All-in-One device simplifies the cementing process with fewer cementing components and fewer moving parts. RALLY All-in-One is ideal for total joint replacements typically using just less than 2 boxes of cement in a syringe application.

VORTEX NozzlesA Standard Breakaway Nozzle is included with the RALLY All-in-One device and the VORTEX Vacuum Mixing System, but for other needs, a variety of specialty nozzles are available including a Long Tapered Nozzle for radial impaction grafting, a long and flexible Revision Nozzle for revision hip surgery, an Angled Nozzle to deliver cement to the tibia during total knee arthroplasty and an Umbrella Interfacer to clean and pressurize the femoral canal.

RALLY and VORTEX GunsThe RALLY and VORTEX guns offer steady, pressurized delivery of cement.

PressurizersOne Medium Femoral Pressurizer is included in the Prep-IM™ Total Hip Preparation Kit that has been shown necessary for better femoral canal filling and reduction of voids in the cement mantle.3,4

Cat. No. Description

7127-1560 RALLY™ HV Bone Cement, 40 grams

7127-1570 RALLY HV AB Bone Cement, 40 grams

7127-1580 RALLY MV Bone Cement, 40 grams

7127-1590 RALLY MV AB Bone Cement, 40 grams

7127-1340 VERSABOND™ Bone Cement, 40 grams

7127-1440 VERSABOND AB Bone Cement, 40 grams


7127-1600 RALLY HV AB All-in-One System, 70 grams

7127-1680 RALLY MV AB All-in-One System, 70 grams

7127-0070 VORTEX™ Vacuum Mixing System

7127-0071 VORTEX Re-use Kit

7127-0068 VORTEX Vacuum Mixing Bowl

210098 Mixing Bowl w/ Spatula

7127-0020 MIXOR™ Vacuum Mixing System w/ Syringe

7127-0069 VORTEX Vacuum Mixing Sample

7127-0090 MIXOR System w/ Syringe Sample


7127-0080 VORTEX Standard Breakaway Nozzle

7127-0081 VORTEX Long Tapered Nozzle

7127-0082 VORTEX Angled Nozzle

7127-0084 VORTEX Revision Nozzle

7127-0085 VORTEX Umbrella Nozzle

7127-0072 VORTEX Nozzle Adaptor


7127-1610 RALLY All-in-One Cement Gun

7127-2001 VORTEX Cement Gun

7127-0042 MIXOR Foot Pump Only

7127-0041 MIXOR Vacuum Hose Only

7127-0050 MIXOR Foot Pump Connector, Shraeder

7127-0051 MIXOR Foot Pump Connector, Drager

7127-0052 MIXOR Foot Pump Connector, D.I.S.S

7127-0060 MIXOR Stryker Foot Pump Adapter

Bone Cement

Mixer and Dispensing Components Mixing Systems

Nozzles

Mixing and Dispensing Accessories

Catalog informationCement Mixers and Accessories


91-4535 BUCK Cement Restrictor, 13mm

12-9418 BUCK Cement Restrictor, 18.5mm




7127-9422BUCK Cement Restrictor w/ Disposable Inserter, 18.5mm

7127-9423BUCK Cement Restrictor w/ Disposable Inserter, 25mm

7127-9424BUCK Cement Restrictor w/ Disposable Inserter, 30mm

11-2428 BUCK Cement Restrictor Inserter

11-0028 Vent Opening Tool


7127-7000 Handpiece w/ Zimmer Coupling

7127-7001 Powerhose w/ Zimmer Coupling

7127-7004 Hip/Knee Disposable Unit w/ Suction

7127-7005 Hip/Knee Disposable Unit w/o Suction


12-1010 Prep-IM Enhance Total Hip Kit

Includes:

12-9418 BUCK Cement Restrictor, 18.5mm


11-2428 BUCK Disposable Inserter

11-0003 Femoral Canal Brush, 19mm

11-0037 Femoral Canal Suction Absorber, Std

7127-0027 Medium Femoral Pressurizer

11-1000 CONCISE™ Cement Sculps

Bone Cement

Mixer and Dispensing Components Mixing Systems

Cement Accessories BUCK™ Cement Restrictors

Pulse Lavage POWERPULSE™ Lavage System

Nozzles

Prep-IM™ Enhance Total Hip Kit

Mixing and Dispensing Accessories

Catalog informationCement Mixers and Accessories

References1. Internal testing on file at Smith & Nephew.2. Ref: Smith & Nephew OR 15-1353. Lee C. Bone Preparation: The importance of establishing the best bone-cement interface. The Well-Cement Total Hip Arthroplasty: Theory and Practice. edited by Breusch and Malchau. Springer. 2005.4. Mulroy RD, Harris WH. The Effect of improved cementing techniques on component loosening in total hip replacement. JBJS 1990; 72-B.

DisclaimerPlease see the Instructions for Use for each product for a complete list of indications, warnings, precautions and other important medical information.

Smith & Nephew, Inc. www.smith-nephew.com1450 Brooks RoadMemphis, TN 38116USA

Telephone: 1-901-396-2121 Information: 1-800-821-5700 Orders and Inquiries: 1-800-238-7538 ©2015 Smith & Nephew, Inc. ™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.All Trademarks acknowledged. 04139 V1 10/15

Cementing better outcomes

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