The information contained in this document is intended for healthcare professionals only.

Orthopaedics

Simplex P Bone Cement

Simplex P with Tobramycin

The Perfect Blend of Confidence and Performance

Simplex P Bone Cement

Reliable Predictable Trusted

Cementing Success... begins with Simplex P

Bone Cement of Historic Proportion 1958 1962 1971 For over 40 years, Simplex P Bone Cement has earned the

Simplex C Cement introduced in Europe Simplex P Bone Cement introduced in Europe Simplex P Bone Cement first to receive FDA approval in US for total hip arthroplasty Simplex P Bone Cement approved for total knee arthroplasty in US Simplex P Antibiotic Bone Cement with Erythromycin and Colistin introduced in Europe Simplex P Bone Cement approved for use in pathological fractures and general prosthetic fixation Simplex P Bone Cement with Tobramycin introduced in Europe Simplex P Bone Cement with Tobramycin introduced in US

trust and confidence of tens of thousands of surgeons. With over 20 million doses implanted, no other bone cement can match the experience of Simplex P Bone Cement. Hundreds of articles in respected, peer-reviewed journals confirm the outstanding performance of Simplex P Bone Cement. At the heart of this illustrious history is the science behind the success of Simplex P Bone Cement a unique chemical composition that has become the orthopaedic standard by which all other bone cements are measured the standard to which no other bone cement measures up. The key to the outstanding long-term performance of Simplex P resides in its unique chemical formula and proprietary manufacturing process. This formula imparts excellent viscosity and porosity characteristics that add up to superior fatigue strength and mechanical properties.3-14
Chemical Composition:

1973

1975

1976

2000

2003

Only Simplex P uses the proven 75-15-10 mix: 75% Methylmethacrylate-styrene-copolymer for strength, 15% Polymethylmethacrylate for handling and 10% Barium Sulfate for radiopaqueness.

75% +
Methylmethacrylate-styrene-copolymer plus...

15% +
Polymethylmethacrylate (PMMA) plus...

Styrene and methylmethacrylate are combined via a proprietary manufacturing process to form beads of varying size.

Methylmethacrylate is processed to form the unique PMMA "flake" that increases wettability and improves handling characteristics.

Bone Cement Manufacturing... that is unequaled

Simplex P Bone Cement provides the right ingredients in the right formula, balancing unrivaled strength with

consistent handling for dependable intraoperative and long-term clinical results. Exclusive to the Simplex P manufacturing process is 1) the method by which benzoyl peroxide is encapsulated within each Methylmethacrylate-styrene-copolymer bead and 2) the unique process of manufacturing the PMMA flake.
1) Benzoyl peroxide is crucial for determining the mixing, handling

cement powders on the market. The combination of flakes and beads in the Simplex P polymer allow for better wetting of the polymer by the monomer (liquid component). This provides for the optimal handling characteristics of Simplex P. These manufacturing processes are unique only to Simplex P Bone Cements. No other manufacturer of bone cement has been able to copy this process.

and setting characteristics of bone cement. By encapsulating the benzoyl peroxide in every copolymer bead, Simplex P delivers consistent results. Products that include benzoyl peroxide as an added ingredient to the entire polymer (powder) component may include a statement in their labeling to explain that components of different lots cannot be mixed. A potential reason lot codes of different batches cannot be mixed is the variability in the manufacturing (benzoyl peroxide content) from batch to batch. With Simplex P Bone Cement, lot codes can be mixed from batch to batch which is crucial for dependable, predictable results.
2) Unlike the styrene copolymer that looks like a bead, the PMMA
Co-polymer

PMMA Homopolymer (no flake)

Clumps of Barium

component is manufactured as a flake. It is due to these flakes that the powder is noticeably fuller, and less dense than other bone

DePuy Endurance Powder Mixture Complete Note different particle size and shape versus Simplex P below.

10% =
Barium equals...

The Orthopaedic Standard

Simplex P Powder Mixture Complete

Barium sulfate is blended under special controls to ensure uniform barium dispersion that is free of clumps.

Note beads and flakes, as compared to DePuy Endurance above.

Formulating Bone Cement... as the model for all others

Low Viscosity Cements

Zimmer Osteobond is a low viscosity formulation. Simplex P has demonstrated superior survival results when compared to low viscosity cements in both the Norwegian and Swedish hip registries1,2. Unlike Simplex P, the Osteobond formula does not balance styrene with PMMA. This results in a low-viscosity cement plagued by unfavorable handling properties.
Medium Viscosity Cements

DePuy Endurance is a medium viscosity cement, similar in handling characteristics to Simplex P. However, reformulated cements such as Endurance have attempted to become a new copy-cat cement by blending a variety of formulas. An unfavorable consequence of this approach is the development of a cement that lacks the clinical history and data to support its use.
High Viscosity Cements

At the other end of the spectrum is DePuy 1, DePuy SmartSet HV and Biomet Palacos R. High-viscosity cements are compromised primarily of PMMA with no Methylmethacrylate-styrene-copolymer content. High viscosity formulas that become doughy too quickly can be difficult to mix, causing air to become entrapped in the cement. This may increase porosity and consequently reduce fatigue strength3-13. Using a vacuum mixer to remove porosity and pressurizing high viscosity cements may improve the fatigue strength, although they have not been shown to be able to be pressurized as easily as medium viscosity cements.

Many manufacturers of bone cement claim that all bone cements are alike and are attempting to sell bone cement as

a commodity product. They are minimizing the fact that bone cement is an orthopaedic implant and the long-term performance of bone cement is critical to the longevity of the orthopaedic procedure performed.

Methyl Methacrylate Styrene Copolymer

Poly Methylmethacrylate

Barium Sulfate

Benzoyl Peroxide

Poly Methylmethacrylate Methacrylate Copolymer

Methylmethacrylate Methyl Acrylate Copolymer

Zirconium Dioxide

Chlorophyll

The Unique Simplex P Formula

Proven for over forty years with over 18 million doses implanted. Simplex P Bone Cement is the original and most copied bone cement...often mimicked, never matched.

Note: Styrene content, molecular weight, and morphology vary by manufacturer. Formulations as per manufacturers package inserts. *The 1.7% Bpo content is contained within the styrene copolymer content and not as a separate ingredient. **Data unavailable.

Consistent Cement Performance... leading to clinical success

Greater Strength

When mixed mechanically in a vacuum, the fatigue strength of Simplex P was 3-times greater than DePuy 1 (CMW) testing to 1,540 cycles x 103 versus 350 x 103. Similar results have been reported in numerous other comparative studies3-14.
Fatigue Testing:

Mean number of cycles to failure of mechanically mixed cement in a vacuum3.

Greater Intrusion

Penetration of cement into bone can also be directly measured as intrusion depth. Simplex P Bone Cement is superior to Palacos15. At room temperature, Simplex P achieves at least 50% deeper intrusion compared to Palacos15.
Cement Intrusion Depth into Cancellous Bone (mm): DePuy 1 CMW Simplex P

Measured at: 20psi, 40psi.

Palacos Simplex P

20 psi

1.4mm

2.2mm

40 psi

2.4mm

4.2mm

Mean Shear Strength at the Cement-to-Bone Interface (Mpa)

Note: 1 Mpa (megapascal) = 145psi. 7.3

MPa

6.2
MPa

3.7
MPa

DePuy CMW 1

Palacos

Simplex P

Deeper penetration means increased strength

The deeper cement penetrates into bone, the stronger the fixation and shear strength of the bond. Bone penetration is affected by cement viscosity. High viscosity cements such as DePuy 1, SmartSet HV and Palacos are too thick to penetrate deeply into the cancellous/trabecular bone matrix. Simplex P Bone

Cement is formulated to just the right viscosity to achieve superior bone penetration and maximum shear strength16. As a result, tests prove Simplex P Bone Cement withstands nearly twice the mean shear stresses at the cement to bone interface as DePuy 1, and almost 20% more stress than Palacos16.

Deeper Penetration

Superior Elution of Tobramycin

Excellent Intrusion Depth

Creep Percent Relaxation at 500 hours

62%
Palacos

34%
DePuy CMW1

19%
Simplex P

Less Creep

Creep or plastic deformation, is a mechanical problem that can slowly, steadily erode longterm implant performance. Bone cements that creep too much may lead to component shifting, loosening, and failure. Simplex P creeps significantly less than Palacos17.

The Perfect Blend... of Confidence and Performance

Simplex P with Tobramycin Bone Cement is

comprised of 40g of Simplex P Bone Cement powder plus 1g of tobramycin. The liquid monomer portion is unchanged from the original Simplex P Bone Cement monomer. As a result, the superior mechanical properties surgeons expect with Simplex P Bone Cement are inherent in Simplex P Bone Cement with Tobramycin18,19.

Simplex P with Tobramycin Bone Cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty.*

With pre-blended Simplex P with Tobramycin Bone Cement, surgeons can feel confident that the tobramycin is being optimally delivered to the patient. It is manufactured, blended and tested to ensure even distribution of the tobramycin throughout the mixture, and that the mixture is consistently smooth. The controlled addition of tobramycin powder does not alter the unsurpassed mechanical properties of Simplex P Bone Cement18,19. The graphs below demonstrate that the handling properties, and strength of Simplex P with Tobramycin Bone Cement are unchanged from Simplex P.

Fatigue Cycles to Failure

Tested at 20MPa and 3 cycles/second. Internal mechanical testing confirms that fatigue strength is unaffected by the addition of 1g. tobramycin.

Handling Properties

The handling properties of Simplex P with Tobramycin are unchanged from those of Simplex P Bone Cement.

* U.S. indications only. Europe and Canada are not limited to the second stage of a two-stage revision. Note: 1 MPa (megapascal) = 145psi. Data on file at Stryker Orthopaedics.

Tobramycin... the antibiotic of choice*

Other

Tobramycin is the antibiotic of choice for more than 75%

of orthopaedic surgeons in the US 20 for several important reasons: Ability to withstand exothermic temperatures of polymerizing cement Low allergy potential versus cephalosporins21 Excellent safety profile Proven elution from Simplex P Bone Cement22-24 Better elution than gentamicin25 Broad spectrum antibiotic Used safely for over 20 years in orthopaedics26, 27
Gentamicin Vancomycin

Cephalosporin

More than one antibiotic commonly used

Antibiotic of Choice for use with Bone Cement

* Percentages shown total greater than 100%. Surgeons surveyed were offered the choice to select more than one antibiotic.

Simplex with Tobramycin... the elution solution

When antibiotics are blended with bone cement, serum Clinical Elution from Simplex P with Tobramycin13,14

levels are controlled by the degree of antibiotic release. Tobramycin elutes in high concentrations from Simplex P Bone Cement and is concentrated locally. Low serum levels are maintained, minimizing the potential for toxicity and associated adverse side effects. In pre-clinical and clinical studies with Simplex P with Tobramycin Bone Cement, systemic tobramycin levels remained well below the toxic threshold23, 28, 29 (see graph at right). Lab studies comparing the release of 1g tobramycin from Simplex P with Tobramycin Bone Cement and 1g Gentamicin from Palacos, have found that tobramycin elutes in higher concentrations. This is consistent with data comparing the release of tobramycin and gentamicin from Simplex P, Zimmer and Palacos bone cements. The results: tobramycin released better than gentamicin from all three cements. In a direct comparison of average total antibiotic release, there is a significant difference between Simplex P with Tobramycin as compared to Palacos and Zimmer bone cements with gentamicin (see graph below right)25. Simplex P with Tobramycin Bone Cement is the perfect blend offering surgeons the confidence of their number-one bone cement plus their first-choice antibiotic. For experience, strength, consistency and dependability, no other bone cement comes close to Simplex P with Tobramycin Bone Cement. Palacos
with Gentamicin

Elution Characteristics: Tobramycin vs. Gentamicin

Zimmer
with Gentamicin

Simplex P
with Tobramycin

10

Simplex P... the most documented bone cement

References
1. Havelin LI, Espenhaug B, Vollset SE, Engester LB. The effect of the type of cement on the early revision of Charnley total hip prostheses. J Bone Joint Surg. 1995; 1543-1550. 2. Malchau H, Herberts P. Prognosis of total hip replacement Revision and re-revision rate in THR : a revision-risk study of 148,359 primary operations. AAOS national meeting 1998. 3. Linden U. Fatigue properties of bone cement: Comparison of mixing techniques. ACTA Orthop Scand. 1989: 60(4): 431-433. 4. Hansen D, Steen JJ. Mixing does not improve mechanical properties of all bone cements: manual and centrifugation-vacuum mixing compared for 10 cement brands. Acta Orthop Scand. 1992; 63(1):13-18. 5. Davies J, Burke D, OConnor D, Harris W. Comparison of the fatigue characteristics of centrifuged and uncentrifuged Simplex P Bone Cement. J Orthop Res. 1987; 5:366-371. 6. Davies J, Jasty M, OConnor D, Burke DW, Harrigan T, Harris W. The effect of centrifuging bone cement. J Bone Joing Surg (Br). 1989; 71-B: 39-42. 7. Jasty M, Davies J, OConnor D, Burke D, Harrigan T, Harris W. Porosity of various preparations of acrylic bone cements. Clin Orthop Rel Res. 1990; 259: 122-129. 8. Wixson RI. Do we need to vacuum mix or centrifuge cement? Clin Orthop Rel Res. 1992; 285: 84-90. 9. Lewis G. Properties of acrylic bone cement: State of the art review. J Bio Mater Res. 1997; 38: 155-182. 10. Holm N. The modulus of elasticity and flexural strength of some acrylic bone cements. Acta Orthop Scand. 1977; 48: 436-442. 11. Gates E, Carter D, Harris W. Comparative fatigue behavior of different acrylic bone cements. Clin Orthop Rel Res. 1984; 189: 294-299. 12. Davies J. OConnor D. Burke D. Jasty M, Harris W. The effect of centrifugation on fatigue life of bone cement in the presence of surface irregularities. Clin Orthop Rel Res. 1988; 229: 156-161. 13. Linden U. Mechanical properties of bone cement: Importance of the mixing technique. Clin Orthop Rel Res. 1991; 272: 274-278. 14. Hansen D, Steen JJ. Additional mechanical tests of bone cements. Acta Orthop Beligica. 1992; 58(3): 268-271. 15. Rey R, Paiement G, McGann W, et al. A study of intrusion characteristics of low viscosity cement Simplex P and Palacos cement in a bovine cancellous bone model. Clin Orthop Rel Res. 1987; 215: 272-278.erences 16. MacDonald W, Phil M, Aust MIE, Swarts E, Beaver R. Penetration and shear strength of cement-bone interfaces in-vivo. Clin Orthop Rel Res. 1993; 286: 283-288. 17. Holm N. The relaxation of some acrylic bone cements. Acta Orthop Scand. 1980; 51: 727-731. 18. Murray WR, Use of antibiotic-containing bone cement. Clin Orthop Rel Res 1984 Nov(190): 89-95. 19. Davies JP, Harris WH. Effect of hand mixing tobramycin on the fatigue strength of Simplex P. J Biomed Mater Res. 1991; 25(3):1409-1414. 20. Fish DN, Hoffman HM, Danziger LH. Antibiotic-impregnated cement use in US hospitals. Am J Hosp Pharm. 1992;49: 2469-2474. 21. Popham GJ, Mangino P, Seligson D, Henry SL. Antibiotic-impregnated beads. Part II: Factors in antibiotic selection. Orthop Rev. 1991 Apr; 20(4): 331-7. 22. Brien WW, Salvati EA, Klein R, Brause B, Stern S. Antibiotic impregnated bone cement in total hip arthroplasty. Clin Orthop. 1993;296: 242248. 23. Nijhof M, Dhert W, Tillman P, Verbout A, Fleer A. Release of tobramycincontaining bone cement in bone and serum of rabbits. J Mat Sci Mat Med. 1997;8(12):342353. 24. Scott CP, Higham PA, Dumbleton JH. Effectiveness of bone cement containing tobramycin: An in vitro susceptibility study of 99 organisms found in infected joint arthroplasty. J Bone Joint Surgery (Br). 1999; 81-B:440-443. 25. Nelson, CL, Griffin, FM, Harrison BH, Cooper RE. In vitro elution characteristics of commercially and noncommercially prepared antibiotic PMMA beads. Clin Orthop. 1992 Nov (284): 303-9. 1992. 26. Heck D, Rosenberg A, Schink Ascani M, Garbus S, Kiewitt T. Use of antibioticimpregnated cement suring hip and knee arthroplasty in the United States. J of Arthrop. 1995;10(4): 470-475. 27. Soto Hall R, Saenz L, Tavernetti R, Cabaud HE, Cochran TP. Tobramycin in bone cement. An in-depth analysis of wound, serum, and urine concentrations in patients undergoing total hip revision arthroplasty. Clin Orthop. 1983, May(175):60-4. 28. Sterling GJ, Potter JM, Koerbin G, Crawford S, Crawford R, 2002. The pharmacokinetics of Simplex Tobramycin Bone Cement. A Study investigating the elution characteristics of Simplex Tobramycin Bone Cement in total hip replacement. J Bone Joint Surg (Br) 2003; 85-B:646-9. 29. Physicians Desk Reference Edition 54, Medical Economics Company, Inc., Montvale NJ. 2000; 1628-1631.

Simplex P with Tobramycin

The Perfect Blend of Confidence and Performance

Ordering Information
6197-9-010 Full Dose 10-pack

Joint Replacements Trauma Spine Micro Implants Orthobiologics Instruments Interventional Pain Navigation Endoscopy Communications Patient Handling Equipment EMS Equipment

Simplex P Bone Cement

Reliable Predictable Trusted

Ordering Information
6191-1-001 Full Dose Individual Box 6191-1-010 Full Dose 10-pack 6188-1-001 Half Dose Individual Box 6188-1-010 Half Dose 10-pack

Stryker Orthopaedics Customer Service (U.S.) 1-877-946-9678 Stryker Canada Customer Service 1-800-668-8323 For information on Stryker Bone Cement Mixers and Accessories call Stryker Instruments Customer Service 1-800-253-3210

325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000 www.stryker.com

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which treatments and procedures to use with patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. The marks bearing the symbol are trademarks of Stryker. The marks bearing the symbol are registered trademarks of Stryker. Depuy, Endurance, Generation 4, Osteobond, Palacos, SmartSet, and Zimmer are not trademarks of Stryker. Literature Number: LSB TG/GS 2.5M 12/04 8352 Copyright Stryker 2004 Printed in USA.