Modern Cementing Technique Brochure - Zimmer Biomet · PDF file2 | Modern Cementing Technique. Modern Cementing Technique Knee (MCT Knee) is a concept within knee arthroplasty. This

Modern Cementing TechniquePALACOS® Bone Cement, ClearMix™ Vacuum Mixing System and Quick-Vac® Vacuum Mixing Bowl

2 | Modern Cementing Technique

Modern Cementing Technique Knee (MCT Knee) is a concept within knee arthroplasty. This concept addresses implant loosening and the objective is to provide long term implant stability in knee arthroplasty. It is based on scientific data,1-26* findings by Zimmer Biomet 27 and evidence-based techniques documented in the Swedish Hip Arthroplasty Register.3-4

The crucial factors in knee arthroplasty to achieve long term implant stability are to secure a strong bond and optimal interfaces, both between implant-cement and cement-bone. To address the risk of de-bonding and thus loosening of the implant follow the established MCT concepts below:

Implant-Cement Interface• Deliver the cement with a cement gun, CementON® Tibial Mold and appropriate delivery devices, such as knee nozzles

• Apply bone cement to implant first, as early as possible (no waiting phase)

• Prevent implant-cement interface contamination

by implementing a “no-touch” policy

Bone Cement• Use a bone cement with good mechanical and consistent handling properties

• Mix and collect the cement under vacuum to reduce cement porosity and

to improve mechanical strength 8, 28*

Cement-Bone Interface• Perforate cancellous bone if dense or sclerotic 24

• Clean with high pressure pulsatile lavage repeatedly until clear fluid is received in the return line

• Deliver the cement with a cement gun and appropriate delivery devices, such as knee nozzles

• Deliver bone cement into tibial stem hole

to achieve full cementation 21-23

Implant-Cement Interface

Cement-Bone Interface

IMPLANT

CEMENT

BONE

*Bench test results not necessarily indicative of clinical performance.

Secure a Strong Bond and Optimal Interfaces between Implant-Cement and Cement-Bone


*Lab test results not necessarily indicative of clinical performance.

IMPLANT

CEMENT

BONE

General Clinical Problem in Knee Arthroplasty: Tibial LooseningTibial loosening between cement and implant is not limited to any particular cement

brand or tibial component design. The overriding factor is the cementation technique.2*

• Knee revisions in US 2014 were projected to be 75,500 with an annual growth rate of 4.8%29

• Aseptic loosening of cemented tibial components remain a major cause of failure. It is shown in literature to account for 24% of all knee revisions.1

• Micro motion at the implant-cement or cement-bone interface can generate wear particles. 30

Cement ApplicationOptimized micro-mechanical interlock can be achieved with early applied bone cement to a non-contaminated implant surface.27*

Implant - Cement Interface

Tensile-Adhesion Strength of PALACOS® on 30 grit blast CoCr 27*

No Contaminant PBS Blood Fat

Ten

sile

-Ad

hes

ion

Str

eng

th (p

si)

Time of Cement Application

00

2,000

1,800

1,600

1,400

1,200

1,000

800

600

400

200

7654321

Early-Applied Cement

Grit-Blasted Substrate

Late-Applied Cement


Contaminated Interface



Implant-Cement Interface SolutionTo achive an optimized micro-mechanical interlock, apply the bone cement to implant first, as early as possible (no waiting phase), using the flat knee nozzle.

Independent Study with Stryker Triathlon® Tibial Trays and Simplex® and PALACOS® Bone Cements2*Lab Study by Aaron Kavanaugh, Thomas Schmalzried and Fabrizio Billi

Conclusions• Under laboratory conditions, a clean tibial tray-cement interface is strong,

but much stronger when the keel is cemented.

• Earlier application of the cement to metal increases bond strength while later application reduces bond strength.

• Fat contamination of the tibial tray-cement interface reduces bond strength, but application of cement to the underside of the tibial tray prior to insertion substantially mitigates this.

*Lab test results not necessarily indicative of clinical performance.

Implant - Cement Interface (cont.)


* Lab test results not necessarily indicative of clinical performance.

Bone Cement

PMMA bone cements fill the space between prostheses and bone, transmitting

and evenly distributing loads. The main considerations are:

• Good mechanical properties

• Consistent handling properties

• Well-documented bone cement

IMPLANT

CEMENT

BONE

Mixing Under VacuumMixing under vacuum reduces both micro and macro pores.8* Deliver the cement with a cement

gun and nozzle suitable for the application.10,11

• Improved cement strength and fatigue life 7

• Lower risk of aseptic loosening due to cracks in the cement 7-10*

• Delivery of reproducible results

• Less exposure to monomer fumes 11*

Cement mixed under vacuum 28*

Cement mixed at atmospheric pressure 28*


Delivery• A uniform, deep bone cement mantle provides for optimal fixation and stress distribution 14*,15

• Application with a cement gun and an appropriate nozzle on both tibia and femur 16-19

• Delivery to a clean, dry bone bed following pulse lavage 7

IMPLANT

CEMENT

BONE

Cement - Bone Interface

Pressurization• Increases penetration into the cancellous bone 20

• Improves interface between bone and cement 7*

* Lab test results not necessarily indicative of clinical performance.


Long term clinical successSince its introduction in 1959, PALACOS cement stands the test of time with a clinical history of low revision risk.31

Excellent handling characteristicsPALACOS cement offers a quick mixing and dough-up time, and a consistent working time long enough not to feel hurried for implant application.

Optimized antibiotic release characteristicsWith the addition of 0.5g Gentamicin, PALACOS R+G offers a broad spectrum of coverage and greater in vitro elution rates compared with other available cement brands containing twice the amount of antibiotics.*32-33

High visualizationThe green color of PALACOS cement improves visualization compared to surrounding bone. PALACOS cement also offers excellent post-operative visualization on x-ray.

Viscosity for every applicationWhen a high viscosity cement is not needed, PALACOS cement is offered in a low viscosity formulation - PALACOS LV and PALACOS LV+G. Using the same time-tested raw materials and its unique green color, these cements can be easily ejected from long, narrow nozzles.

*Bench test results not necessarily indicative of clinical performance.

PALACOS Bone Cement - the unique solution


High quality vacuum mixingClearMix is a high performing vacuum cartridge mixing and delivery system. It allows for a standardized mixing procedure when cement is mixed, resulting in a high quality bone cement. This vacuum mixing system can be used to mix all viscosities of PMMA bone cement.

Practical and easy to useThis easy to use system requires minimal assembly. The mixing rod has a colored indicator that identifies the snap point for breaking. In addition, the vacuum line is equipped with a visual vacuum indicator to ensure proper vacuum level is present before mixing.

Safer working environmentClearMix Vacuum Mixing System meets modern safety standards and the high demands on mixing bone cement in the OR. By drawing the monomer fumes through special filters, the ClearMix System minimizes MMA exposure of the OR staff to a level significantly lower than OSHA and NIOSH guidelines. 27

Clear viewingBased on customer feedback, the clear tube is important as it allows them to see the bone cement during the mixing process.

ClearMix Vacuum Mixing System


ClearMix Vacuum Mixing System is available in two different sizesThe ClearMix Vacuum Mixing System is available as single/double for 40-80g bone cement and as triple for 120g bone cement.

Knee nozzles for improved cement interfacesZimmer Biomet provides knee nozzles for optimal delivery and pressurization of the bone cement.

Nozzle Knee Flat*

Knee Cementation Nozzle*

23-Degree Pressurizing Nozzle*

ClearMix Vacuum Mixing System

40-80g bone cement

ClearMix Triple Vacuum Mixing System

120g bone cement* To be available Q2 2017


Vacuum mixing in a highly visible bowlThe bowl allows excellent visibility and monitoring of the blending process.

Orbiting paddle design optimizes radial coverageThe paddle turns about one and a half paddle turns per crank turn. The rotating axis gives the paddle a pathway that constantly changes providing improved mixing versus a fixed axis bowl.

Large capacity bowlThe large capacity mixing bowl holds up to three 40 gram batches of any type bone cement.

Contoured spatula makes cement removal easyThe spatula design follows the contour of the bowl and allows for quick removal of the cement when ready for application.

Tubing set incorporates charcoal filter and vacuum indicatorThe unique tubing set offers the user a reduction in monomer fumes as well as a visual indicator when to begin mixing.

Quick-Vac Vacuum Mixing Bowl


Product Part Number Description Units/Case

00111214001 PALACOS R 1X40 1

00111314001 PALACOS R+G 1X40 (with Gentamicin) 1

00111814001 PALACOS LV 1X40 1

00111914001 PALACOS LV+G 1X40 (with Gentamicin) 1

Bone Cement Mixing SystemsProduct Part Number Description Units/Case

414702 ClearMix Single/Double 10

414703 ClearMix Triple 1

4146 Nozzle Knee Flat* 5

11003149823-Degree Pressurizing Nozzle and Knee Cementation Nozzle*

5

414700 ClearMix Delivery Gun 1

00504900100 Quick-Vac Mixing Bowl** 1

00504900115 Quick-Vac Mixing Bowl** 15

00504908600 Zimmer® Vacuum Foot Pump II-Air Connector 1

* To be available Q2 2017 **Note: An adapter is packaged with each mixing system for use with the pump

Ordering Information

PALACOS® is a trademark of Heraeus Medical, GmbH, Germany. Under license from Heraeus Medical GmbH, Germany.

Triathlon® and Simplex® are trademarks of Stryker Corporation or its affiliates.

For product information, including indications, contraindications, warnings, precautions, potential adverse events, and patient counseling information, see package insert and www.zimmerbiomet.com.

All content herein, is protected by copyright, trademarks and other intellectual property rights , as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated and must not be redistributed, duplicated or disclosed, in whole or in part without the express written consent of Zimmer Biomet.

This material is intended for health care professionals, the Zimmer Biomet sales force only and Zimmer Biomet employees. The distribution to any other recipient is prohibited.

©2017 Zimmer Biomet

1111.1-US-en-REV0217

Legal ManufacturerSummit Medical LtdIndustrial ParkBourton-on-the-WaterGloucestershire, GL54 2HQ UK

Heraeus Medical GmbHPhilipp-Reis-Straße 8/1361273 WehrheimGermany

www.zimmerbiomet.com

Legal ManufacturerBiomet France SARLPlateau de Lautagne26000 Valenece France

Zimmer Inc1800 West Center StreetWarsaw, Indiana 46580USA

Distributed by:Biomet Orthopedics P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA

Zimmer Inc1800 West Center StreetWarsaw, Indiana 46580 USA

21. Lombardi AV et al. Surface Cementation of the Tibial Component in Total Knee Arthroplasty. Scientific Exhibit, 65th Annual Meeting of the American Academy of Orthopaedic Surgeons, New Orleans, Lousiana. February 19-23, 1998.

22. Sisodial G et al. Does Cementing Technique of the Tibial Component Influence Initial Fixation to Bone in Total Knee Arthroplasty? Full Versus Surface Cementation. Bone Joint J 2013 vol. 95-B no. SUPP 20 6 .

23. Bert JM and McShane M. Is It Necessary to Cement the Tibial Stem in Cemented Total Knee Arthroplasty? Clinical Orthopaedics and Related Research 1998, 356: 73-78.

24. Miskovsky C, Whitesidem L.A, White S.E. The Cemented Unicondylar Knee Arthroplasty. An In Vitro Comparison of Three Cement Techniques. Clinical Orthopaedics Number 284, November 1992.

25. Cawley DT et al. Cementing techniques for the tibial component in primary total knee replacement. Bone Joint J 2013;95-B:295–300.

26. Diaz-Borjon E et al. Cement Penetration Using a Tibial Punch Cement Pressurizer in Total Knee Arthroplasty. Orthopedics May 2004 Volume 27 Number 5.

27. Data on file at Biomet. Bench test results not necessarily indicative of clinical performance.

28. Lidgren, Lars et al. Bone Cement Improved by Vacuum Mixing and Chilling. Acta Orthop. Scand. 57, 27-32, 1987.

29. Millennium Research Group, Inc. Global Markets for Bone Cement and Accessories 2012. Millennium Research Group, RPGL21BC11, December 2011, p: 71.

30. Cheng, Kevin et al. Osteolysis Caused by Tibial Component Debonding in Total Knee Arthroplasty. Clinical Orthopaedics and Related Research, 2006, No. 443: 333-336.

31. Malchau, et al. Prognosis of total hip replacement: Update and Validation of Results from the Swedish National Hip Arthroplasty Register 1979-1998. Scientific exhibition presented at the 67th Annual Meeting of the American Academy of Orthopaedic Surgeons; March 15-19, 2000; Orlando, USA.

32. Meyer, J. et al. Vacuum-Mixing Significantly Changes Antibiotic Elution Characteristics of Commercially Available Antibiotic-Impregnated Bone Cements. Journal of Bone and Joint Surgery. 2011; 93:2049-56.

33. Kuehn K-D, et al. Acrylic Bone Cements: Composition and Properties. Orthop Clin N Am January 2005; 36:17-28.

References

1. Austin MS et al. Knee Failure Mechanisms After Total Knee Arthroplasty. Techniques in Knee Surgery 3(1):55–59, 2004.

2. Kavanaugh A. et al. Transactions of the ORS 2014 Annual Meeting, New Orleans, LA, #1854. Factors Influencing the Initial Strength of the Tibial Tray-PMMA Cement Bond.

3. Malchau H, Herbert P. Prognosis of Total Hip Replacement. The National Hip Arthroplasty Register 1996: 9-11.

4. Malchau H, Herberts P, Eisler T, Garellick G, Söderman P. The Swedish Total Hip Replacement Register.JBJS 2002; 84A: 2-20.

5. Shepard, Michael F., et al. Influence of Cement Technique on the Interface Strength of Femoral Components. Orthopaedics and Related Research, December, 2000,381:26-35.

6. Keller, John C., et al. Factors affecting surgical alloy/ bone cement interface adhesion. Journal of Biomedical Materials Research, 1980, vol. 14,639-651.

7. Breusch SJ. Cementing Techniques in Total Hip Replacement: Factors Influencing Survival of Femoral Components, In Bone cements and Cementing technique ed by Walenkamp G, Murray D, Springer Verlag 2001.

8. Wang J-S, Franzén H, Jonsson E, Lidgren L. Porosity of bone cement reduced by mixing and collecting under vacuum. Acta Orthop Scand 1993, 64 (2): 143-146.

9. Wang J-S, Kjellson F. Bone Cement Porosity in Vacuum Mixing Systems, Bone Cements and Cementing Technique 2001, Walenkamp, Murray (Eds). Springer Verlag.

10. Dunne N-J, Orr J.F. Influence of the mixing techniques on the physical properties of acrylic bone cement. Biomaterials 2001; 22: 1819-1826.

11. Report from SP Technical Research Institute of Sweden (2007 08 13). Airborne methyl methacrylate monomer during the use of different bone cement mixing systems.

12. Clarius M et al. Pulsed lavage reduces the incidence of radiolucent lines under the tibial tray of Oxford unicompartmental knee arthroplasty. Pulsed lavage versus syringe lavage. International Orthopaedics (SICOT) 2009, 33:1585–1590.

13. Christie J et al. Medullary lavage reduces embolic phenomena and cardopulmanory changes during cemented hemiarthroplasty, J Bone Joint Surg [Br] 1995;77- B:456-9.

14. Walker PS et al. Control of Cement Penetration in Total Knee Arthroplasty. Clinical Orthopaedics and Related Research Number 185, May 1984.

15. Miller MA et al. Loss of Cement-bone Interlock in Retrieved Tibial Components from Total Knee Arthroplasties. Clinical Orthopaedics and Related Research January 2014, 472:304-313.

16. Ritter MA et al. Radiolucency at the Bone-Cement Interface in Total Knee Replacement. The Effect of Bone-Surface reparation and Cement Technique.

17. Krause WR et al. Strength of the Cement-Bone Interface. Orthopaedics and Related Research March, 1982, 163:290-299.

18. Lutz MJ et al. The Effect of Cement Gun and Cement Syringe Use on the Tibial Cement Mantle in Total Knee Arthroplasty. The Journal of Arthroplasty Vol. 24 No. 3 2009.

19. Yoga R et al. Use of Cement Gun for Fixation of Tibia Component in Total Knee Arthroplasty. Malaysian Orthopaedic Journal 2009 Vol 3 No 1.

20. Reading AD et al. A comparison of 2 modern femoral cementing techniques: analysis by cement-bone interface pressure measurements, computerized image analysis, and static mechanical testing. J Arthroplasty 2000 Jun;15(4):479-87

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Modern Cementing Technique Brochure - Zimmer Biomet · PDF file2 | Modern Cementing Technique. Modern Cementing Technique Knee (MCT Knee) is a concept within knee arthroplasty. This