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Zimmer, Inc.

Continuum® Acetabular System

Product Description

The power to meet a wide variety of individual patient needs.

Zimmer® Continuum Acetabular System provides highly flexible solutions for orthopedic surgeons who treat a wide range of patients. The system combines the biologic ingrowth of Trabecular Metal™ Technology with Zimmer® advanced bearing options. With one of the most comprehensive systems, surgeons have the ability to address variations of anatomy and choose the bearing technology that best meets the needs of each patient.

  • Highly porous Trabecular Metal® material with over 12 years of clinical history
  • Designed to Provide Initial Stability
  • 0.98 coefficient of friction*
    • Creates an excellent initial scratch fit, reduces micromotion to support better biologic ingrowth
    • This initial stability helps reduce the need for supplemental screws or ancillary fixation

* For non-machined surfaces.

  • Trabecular Metal material characteristics
  • Up to 80% porosity
    • Nearly 100% open-pore structure and up to 80% porosity
    • Allows for more biologic ingrowth
  • Trabecular Metal Acetabular Shells have over 12 years of clinical history1,2
  • Trabecular Metal Implants have over 12 years of clinical history, with more than 75 peer-reviewed journal publications
  • Power to choose advanced bearing technologies to match patient demands 
  • Longevity® Highly Cross-linked Polyethylene is highly resistant to wear and aging with over ten years of clinical history1-11

References

  1. Data on file at Zimmer.
  2. Medel FJ, Kurtz SM, MacDonald DW, et al. First-generation highly crosslinked polyethylene in THA: clinical and material performance. 55th Annual Meeting of the Orthopaedic Research Society Las Vegas, 2009.
  3. Kärrholm J, Five to seven years experiences of highly crosslinked PE. Abstract number 19059, SICOT Hong Kong, August 2008.
  4. McCalden RW, MacDonald SJ, Rorabeck CH, Bourne RB, Chess DG, Charron KD, Wear Rate of Highly Crosslinked Polyethylene in Total Hip Arthroplasty. A Randomized Controlled Study, J Bone Joint Surg Am. 2009; 91: 773-82.
  5. Bragdon, CR, et al., Seven to Ten Year Follow-Up of Highly Crosslinked Polyethylene Liners in Total Hip Arthroplasty, Poster No. 2444, 55th Annual Meeting of the Orthopaedic Research Society, Las Vegas, 2009.
  6. Wannomae KK, et al., In vivo oxidation of retrieved crosslinked ultra-high molecular-weight polyethylene acetabular components with residual free radicals, J Arthroplasty. 2006; 21(7): 1005-1011.
  7. Collier JP, et al., Comparison of cross-linked polyethylene materials for orthopaedic applications, Clin Orthop. 2003; 414: 289-304.
  8. Bhattacharyya S et al., Severe In Vivo Oxidation in a Limited Series of Retrieved Highly-Crosslinked UHMWPE Acetabluar Components with Residual Free Radicals, 50th Annual Meeting of the Orthopaedic Research Society, Paper 0276, Las Vegas, 2004.
  9. Jibodh, SR, et al., Minimum Five Year Outcome and Wear Analysis of Large Diameter Femoral Heads on Highly Crosslinked Polyethylene Liners, Poster No. 2445, 55th Annual Meeting of the Orthopaedic Research Society, Las Vegas, 2009.
  10. Bragdon CR, et al., Minimum 6-year Follow up of Highly Crosslinked Polyethylene in THA, Clin Orthop. December 2007; (465): 122-127.
  11. Digas et al., Crosslinked vs. Conventional Polyethylene in Bilateral Hybrid THR Randomised Radiostereometric Study, 50th Annual Meeting of the Orthopaedic Research Society, Poster No. 0319, Las Vegas, 2004.
  12. Rieker CB, Schön R, Köttig P, et al. Development and validation of a second-generation Metal-on-Metal bearing: laboratory study and analysis of retrievals, J Arthroplasty. 2004;19 (8, suppl 3): 5-11.

Surgical Techniques and Related Guides

Initial Stability

0.98 coefficient of friction*1

Creates an excellent initial scratch fit, reducing micromotion, which supports better biologic ingrowth.

This initial stability helps reduce the need for supplemental screws or ancillary fixation.

Facilitates OR time savings with potentially fewer surgical steps.

*Against cancellous bone, for non-scratch surfaces such as the Trabecular Metal Modular Shell and Continuum Shell.

continuum-as-grph1

Long-term Fixation

Continuum Illustration

80% porosity2,3

Excellent osteoconductivity due to nearly 100% open pore structure and 80% porosity.

Allows for more rapid bone and soft tissue ingrowth.

Supports a vascularized structure to maintain healthy bone.

10+ Years of Clinical History

10+ years of clinical history, with 75 peer-reviewed journal publications.

Since 1997, over 250,000 Trabecular Metal™ components have been implanted worldwide.

Longevity® Highly Crosslinked Polyethylene Highly Resistant to Wear

continuum-as-grph2

89% reduction over standard Polyethylene7

E-beam irradiation produces greater crosslinking than gamma irradiation for any given dose8,9

Longevity Polyethylene 10Mrad E-beam irradiation produces the highest crosslinked material on the market.9

More crosslinking provides better wear characteristics.

Highly Resistant to Aging4,10-12

Free radicals can lead to oxidation, lowering mechanical properties and increasing wear.13-17

Longevity Polyethylene is heated above its melt temperature, reducing free radicals to nearly non-detectable levels.4,14,18,19

Longevity Polyethylene’s lower free radical levels result in increased long-term mechanical strength.13-15

continuum-as-grph3

Works as Predicted

Continuum Illustration

In vivo

10+ years of clinical experience

More than 1 million Zimmer® Highly Crosslinked Polyethylene Liners implanted7

In a seven-to-ten year follow-up of 247 primary THAs using Zimmer Highly Crosslinked Liners, femoral head penetration did not increase over time after the first year of implantation using 241 primary THAs using standard polyethylene as the control.20

In vitro 6

Independent testing has shown that the in vitro wear rate of Zimmer’s Highly Crosslinked Polyethylene was near zero and lower than that of its competitors.

Metal-on-Metal

Metasul® Forged Metal-on-Metal Technology The Strength of Metal-on-Metal

Stability
Metal-on-Metal liners allow for a larger head size versus a polyethylene liner.

A larger head may increase jump height and reduce the risk for dislocation.

Function
A larger head size allows for greater range of motion before impingement and its associated risks for dislocation.21,22

continuum-as-ills4

Very Low Wear Characteristics

Metasul Technology high carbon cobalt chromium alloys have wear 64% to 94% lower than low carbon cast CoCr alloys.1-12, 22-25

Metasul Head and Liners are processed via wrought forging and therefore have a smoother surface than cast alloys.26

This low surface roughness minimizes frictional torque and improves lubrication, resulting in lower wear.16,17

Extensive Clinical History27-34

continuum-as-grph5

20+ years of published clinical history.

Launched in 1988, with over 460,000 implantations worldwide.

More than 50 independent publications have discussed the performance of Metasul Technology bearings.

BIOLOX® delta Ceramic Technology*

Continuum Illustration

Very Low Wear

Ceramic surface hardness reduces friction and improves wear26

Favorable wetting characteristics of ceramic contribute to better lubrication and lower wear26

High Fracture Resistance

BIOLOX delta toughness and bending strength is more than double over pure Alumina ceramics through the addition of zirconia and strontium oxide26

Zirconia prevents the initiation and/or propagation of cracks

Strontium oxide forms platelet-like crystals to deflect cracking

*Biolox is a trademark of CeramTec AG.

Feature References

  1. Zhang Y, et al., Interfacial frictional behavior: cancellous bone, cortical bone, and a novel porous tantalum biomaterial. J Musculoskeletal Res. 1999; 3(4): 245-251.
  2. Levine B. A new era in porous metals: applications in orthopaedics, Advanced Engineering Materials. August 2008; 10(9): 788-792.
  3. Barbella M. Materials marvels: titanium is a top choice for implants, but other materials are gaining popularity. Orthopaedic Design & Technology. September 1, 2008.
  4. Collier JP, et al., Comparison of cross-linked polyethylene materials for orthopaedic applications, Clin Orthop. 2003; 414: 289-304.
  5. McKellop H, et al., Development of an extremely wear- resistant ultra high molecular weight polyethylene for total hip replacements. J Orthop Res. 1999; 17: 157-167.
  6. Muratoglu OK, et al., The comparison of the wear behavior of four different types of crosslinked acetabular components. 46th AnnualMeeting of the Orthopaedic Research Society. Paper 0566. 2000.
  7. Data on file at Zimmer.
  8. Muratoglu, et al., Identification and quantification of irradiation in UHMWPE through trans-vinylene yield, J Biomed Mat Res. 2001; 56(4): 584-592.
  9. Santavirta S, et al. Alternative Materials to improve total hip replacement tribology. Acta Orthop Scand. 2003; 74: 380-388.
  10. St. John KR, Zardiackas LD, Poggie RA: Wear evaluation of cobaltchromium alloy for use in a metal-on- metal hip prosthesis. J Biomed Mater Res. 68B, 2004: 1-14.
  11. Firkins PJ, Tipper JL, Saadatzadeh MR, et al: Quantitative analysis of wear and wear debris from metalon- metal hip prostheses tested in a physiological hip joint simulator. Biomed Mater Eng. 2001; 11: 143-57.
  12. Chan FW, Bobyn JD, Medley JB, et al. Wear and lubrication of Metal-on-Metal implants. Clin Orthop. 1999; 369: 10-24.
  13. Bohl JR, Bohl WR, Postak PD, Greenwald AS. The Coventry Award. The effect of shelf life on clinical outcome for gamma sterilized polyethylene tibial components. Clin Orthop. October 1999; (367): 28-38.
  14. Wannomae KK, et al., In vivo oxidation of retrieved crosslinked ultra-high molecular-weight polyethylene acetabular components with residual free radicals, J Arthroplasty. 2006; 21(7): 1005-1011.
  15. Bhattacharyya S et al., Severe In Vivo Oxidation in a Limited Series of Retrieved Highly-Crosslinked UHMWPE Acetabluar Components with Residual Free Radicals, 50th Annual Meeting of the Orthopaedic Research Society, Paper 0276, Las Vegas, 2004.
  16. Jin ZM, Analysis of mixed lubrication mechanism in Metal-on-Metal hip joint replacements. Proc Instn Mech Engrs. 2002; 216 (part H): 85-89.
  17. Sharma S, et al., Metal-on-Metal total hip joint replacement: a minimum follow-up of five years. Hip Int, 2007; 17: 70–77.
  18. Muratoglu OK, et al., Knee-simulator testing of conventional and crosslinked polyethylene tibial inserts. J Arthroplasty. 2004; 19(7): 887-897.
  19. Muratoglu OK, Bragdon CR, O’Connor DO, Jasty M, Harris WH. A novel method of cross-linking ultra-high-molecular-weight polyethylene to improve wear, reduce oxidation, and retain mechanical properties. J Arthroplasty. 2001; 16(2): 149-160.
  20. Bragdon, CR, et al., Seven to Ten Year Follow-Up of Highly Crosslinked Polyethylene Liners in Total Hip Arthroplasty, Poster No. 2444, 55th Annual Meeting of the Orthopaedic Research Society, Las Vegas, 2009.
  21. Wang A, Yue S, Bobyn JD, et al., Surface characterization of Metal-on- Metal implants tested in a hip simulator. Wear 225. 1999: 708-715.
  22. Fisher J, Ingham E, Stone MH, et al, Wear and debris generation in artificial hip joints. In: Reliability and Long-term Results of Ceramics in Orthopaedics. Sedel L, William G (eds), Stuttgart-New York, Thieme. 1999: 78-81.
  23. Streicher RM, Semlitsch M, Schön R, et al: Metal-on-metal articulation for artificial hip joints: laboratory study and clinical results. Proceedings of the Institution of Mechanical Engineers, Part H 210, 1996: 223-232.
  24. Tipper Jl, et al., Quantitative analysis of the wear and wear debris from low and high-carbon content cobalt chrome alloy used in metal on metal hip replacements. J Mat Sci: Mat Med. 1999; (6): 353-362.
  25. Scholes SC, Unsworth A: Pin-on-plate studies on the effect of rotation on the wear of Metal-on-Metal samples. J Mater Sci Mater Med. 2001: 12, 299-303.
  26. Kuntz M, Validation of a New High Performance Alumina Matrix Composite for use in Total Joint Replacement. Seminars in Arthroplasty, 2006; 17: 141-145.
  27. Migaud H, et al., Cementless Metal-on-Metal hip arthroplasty in patients less than 50 years of age. Comparison with a matched control group using ceramic-on-polyethylene after a minimum 5-year follow- up. J Arthroplasty. 2004; 19 (8, suppl 3): 23–28.
  28. Long WT, et al., An American experience with Metal-on-Metal total hip arthroplasties. A 7-year follow-up study. J Arthroplasty. 2004; 19 (8,suppl 3): 29–34.
  29. Jessen N, et al., Metal/Metal – A new (old) hip bearing system in clinical evaluation. Prospective 7-year follow-up study. Orthopäde. 2004; 33: 594–602.
  30. Delaunay CP, Metal-on-metal bearings in cementless primary total hip arthroplasty. J Arthroplasty. 2004; 19 (8, suppl 3): 35–40.
  31. Grübl A, et al., Long-term follow-up of Metal-on-Metal total hip replacement. J Orthop Res. 2007; 25: 841–848.
  32. Eswaramoorthy V, et al., The Metasul Metal-on-Metal articulation in primary total hip replacement: clinical and radiological results at ten years. J Bone Joint Surg Br. 2008; 90B: 1278–1283.
  33. Delaunay CP, et al., THA using Metal-on-Metal articulation in active patients younger than 50 years. Clin Orthop Relat Res. 2008; 466: 340-346.
  34. Kim S, et al., Cementless Metasul Metal-on-Metal articulation in active patients younger than 50 years old. J Bone Joint Surg. 2004; (86-A), 2475-2481.
  35. Reitinger A, et al., Clinical eight to ten year results with the cementless Alloclassic/ Metasul (2nd Generation) hip total endoprothesis.  Orthopadische Praxis. 2003; 39, 9, 544-547.
  36. Dorr L, et al., The Argument for the Use of Metasul as an Articulation Surface in Total Hip Replacement.  Clinical Orthopaedics and Related Research. 2004; 429, 80-85.
  37. Triclot P, Metal/ Metal versus Alumina/ Polyethylene: Radio-Clinical retrospective and comparative analysis of the first year of Metasul use with 10 years follow-up. Eur J Orthop Surg Traumatol. 2007; 17, 579-582.
  38. Vassan U, et al., Uncemented metal-on-metal acetabular component: Follow-up of 112 hips for a minimum of 5 years. Acta Orthopaedica. 2007; 78 (4), 470-478.

Indications

The system is indicated for:

  • Primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite
  • Diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
  • The system is intended for use either with or without bone cement in total hip arthroplasty

Contraindications

This device is contraindicated for the following:

  • Osteoradionecrosis
  • Neuromuscular compromise, vascular deficiency, or other conditions in the affected limb that may lead to inadequate skeletal fixation
  • Systemic or local infection
  • Allergy to the implanted material

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