Cementing better outcomes

Transcription

1 Cementing better outcomes

2 The challenge Orthopaedic 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.

3 The solution RALLY Bone Cement Perfect 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.

4 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-mixing 2 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

5 Mechanical properties 2 Compressive Strength MPa Shear Strength MPa Compressive Strength (MPa) A B B B Shear Strength (MPa) RALLY HV Palacos R RALLY MV Simplex P 0 RALLY HV Palacos R RALLY MV Simplex P Bars that do not share the same letter are statistically different. There are no statistical differences between these results. Flexural Strength MPa Flexural Modulus MPa A B A A A B B A,B 60 Flexural Strength (MPa) Flexural Modulus (MPa) RALLY HV Palacos R RALLY MV Simplex P 0 RALLY HV Palacos R RALLY MV Simplex P Bars that do not share the same letter are statistically different. Bars that do not share the same letter are statistically different.

6 Time vs temperature characteristics 1 RALLY HV Bone Cement RALLY HV AB Bone Cement Mixing Phase Mixing Phase 73.0 Dough Phase 73.0 Dough Phase 71.0 Working Phase 71.0 Working Phase Temperature ( F) Setting Phase Temperature ( F) Setting Phase Time (min) Time (min) 77.0 RALLY MV Bone Cement 77.0 RALLY MV AB Bone Cement 75.0 Mixing Phase Dough Phase 75.0 Mixing Phase Dough Phase 73.0 Working Phase 73.0 Working Phase Temperature ( F) Setting Phase Temperature ( F) Setting Phase Time (min) Time (min) Above bone cements were hand mixed. RALLY HV AB All-in-One System RALLY MV AB All-in-One System Mixing Phase Mixing Phase 73.0 Dough Phase 73.0 Dough Phase 71.0 Working Phase 71.0 Working Phase Temperature ( F) Setting Phase Temperature ( F) Setting Phase Setting time (min) Setting time (min) Above All-in-One Systems were not mixed under vacuum.

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8 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 Prep-IM Kit sets the standard in femoral preparation kits. POWERPULSE Lavage System With a variable-speed trigger for greater control, the POWERPULSE system utilizes flexible spray stems and fracture resistant suction tips designed 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. POWERPULSE Lavage System minimizes both contaminated waste and disposal costs.

9 BUCK Cement Restrictor The 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. BUCK Cement Restrictor

10 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 surgery 1. 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 handmixed, 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 Mixer With three revolutions per crank, the preassembled VORTEX mixer saves time and effort in the OR. The VORTEX mixer s angled base delivers a 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 is designed to reduce 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 Bowl For 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. The VORTEX Vacuum Mixer saves time and effort in the OR.

11 RALLY All-in-One In 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 two boxes of cement in a syringe application. VORTEX Nozzles A 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 Guns The RALLY and VORTEX guns offer steady, pressurized delivery of cement. Pressurizers One Medium Femoral Pressurizer is included in the Prep-IM Total Hip Preparation Kit that has been designed to provide necessary for better femoral canal filling and reduction of voids in the cement mantle. 3,4

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14 Catalog information Cement Mixers and Accessories Bone Cement Cat. No. Description RALLY HV Bone Cement, 40 grams RALLY HV AB Bone Cement, 40 grams RALLY MV Bone Cement, 40 grams RALLY MV AB Bone Cement, 40 grams VERSABOND Bone Cement, 40 grams VERSABOND AB Bone Cement, 40 grams Mixer and Dispensing Components Mixing Systems Cat. No. Description RALLY HV AB All-in-One System, 70 grams RALLY MV AB All-in-One System, 70 grams VORTEX Vacuum Mixing System VORTEX Re-use Kit VORTEX Vacuum Mixing Bowl Mixing Bowl w/ Spatula MIXOR Vacuum Mixing System w/ Syringe VORTEX Vacuum Mixing Sample MIXOR System w/ Syringe Sample Nozzles Cat. No. Description VORTEX Standard Breakaway Nozzle VORTEX Long Tapered Nozzle VORTEX Angled Nozzle VORTEX Revision Nozzle VORTEX Umbrella Nozzle VORTEX Nozzle Adaptor Mixing and Dispensing Accessories Cat. No. Description RALLY All-in-One Cement Gun VORTEX Cement Gun MIXOR Foot Pump Only MIXOR Vacuum Hose Only MIXOR Stryker Foot Pump Adapter

15 Cement Accessories BUCK Cement Restrictors Cat. No. Description BUCK Cement Restrictor, 13mm BUCK Cement Restrictor, 18.5mm BUCK Cement Restrictor, 25mm BUCK Cement Restrictor, 30mm BUCK Cement Restrictor, 35mm BUCK Cement Restrictor w/ Disposable Inserter, 18.5mm BUCK Cement Restrictor w/ Disposable Inserter, 25mm BUCK Cement Restrictor w/ Disposable Inserter, 30mm BUCK Cement Restrictor Inserter Vent Opening Tool Prep-IM Enhance Total Hip Kit Cat. No. Description Prep-IM Enhance Total Hip Kit Includes: BUCK Cement Restrictor, 18.5mm BUCK Cement Restrictor, 25mm BUCK Disposable Inserter Femoral Canal Brush, 19mm Femoral Canal Suction Absorber, Std Medium Femoral Pressurizer CONCISE Cement Sculps Pulse Lavage POWERPULSE Lavage System Cat. No. Description Handpiece w/ Zimmer Coupling Powerhose w/ Zimmer Coupling Hip/Knee Disposable Unit w/ Suction Hip/Knee Disposable Unit w/o Suction

16 Supporting healthcare professionals for over 150 years References 1. Internal testing on file at Smith & Nephew. 2. Ref: Smith & Nephew OR 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 Mulroy RD, Harris WH. The Effect of improved cementing techniques on component loosening in total hip replacement. JBJS 1990; 72-B. Disclaimer Please see the Instructions for Use for each product for a complete list of indications, warnings, precautions and other important medical information. Smith & Nephew, Inc Brooks Road Memphis, TN USA Telephone: Information: Orders and Inquiries: Smith & Nephew, Inc. Trademark of Smith & Nephew. All Trademarks acknowledged V2 10/16