CORAIL® PINNACLE®

Bearings and Liners

DePuy Synthes liners are designed to work with the PINNACLE Acetabular Cup System, providing a range of advanced bearing technologies to provide surgeons the power to choose the precise combination that best meets the needs of each patient.

An approach to versatility offers more ways to bring together all the right components and materials for optimised performance. Choose a solution featuring one of three advanced technologies1-13 available – MARATHON®, ALTRX™ and CERAMAX™ ceramic liners.

VIP Taper

VIP taper locks alternative bearing option (ceramic) tightly to the cup

VIP taper does not compromise the critical dome loading for polyethylene liners

Adding enhanced versatility, the PINNACLE cup incorporates the Variable Interface Prosthesis (VIP) taper which supports optimum performance for polyethylene, ceramic and metal liners. For polyethylene liners the VIP taper does not compromise the critical dome loading and for alternative bearing liners (ceramic or metal) it locks the liner tightly to the cup. Anti rotational devices provide rotational stability and resistance to torsional loads for polyethylene liners.

MARATHON

100% survivorship for revision related to wear or loosening of the PINNACLE, minimum 10 years.19

100% survivorship for reoperation related to wear at 10 years.20

No osteolysis at a minimum of 10 years follow up in patients under 30 years.21

MARATHON polyethylene is the first FDA-cleared, third generation, cross-linked polyethylene in the market and was introduced in 1998. Through the MARATHON process (using a base resin barstock of GUR 1050 and moderately cross-linking it at 5 megarads) it reduces wear by 83% in hip simulator studies compared to standard polyethylene, resists oxidation and exceeds minimum ASTM mechanical standards.7,14-16 With the clinically proven wear resistance of MARATHON Cross–Linked Polyethylene, larger head diameters can be used to improve functional range of motion and reduce the risk of dislocation, whilst maintaining adequate thickness of the polyethylene liner.8

MARATHON high performance liners are available for all PINNACLE cup sizes. The internal diameter ranges from 22 mm to 48 mm in line with specific corresponding cups diameters. The MARATHON liners are available in different stability options: neutral, lipped, with 10 degrees of orientation and with 4 mm of extra thickness to adjust offset. Ask your local DePuy-Synthes representatives for more information.

ALTRX

ALTRX - A crosslinked polyethylene optimised to balance wear reduction and mechanical integrity, whilst eliminating oxidation.22, 23

Better head-to-shell ratio – 32/48 and 36/52 neutral liners in ALTRX.

Improved material and technology – 53% reduced wear in comparison to MARATHON with 28 mm heads.24

ALTRX is built on the proven clinical7,14,16,17 experience of MARATHON Cross-Linked Polyethylene and was introduced in 2007. Through the exclusive ALTRA-LINK™ material enhancement process (using a base resin barstock of GUR 1020 and moderately cross-linking it at 7.5 megarads), ALTRX polyethylene is optimised to balance wear reduction and mechanical integrity whilst eliminating oxidation. To address a growing trend toward high demand patients, ALTRX polyethylene liners reduced wear by 92% in an internal laboratory study3-6 versus standard polyethylene and 53%3 versus MARATHON polyethylene liners.

Because ALTRX is moderately cross-linked at 75 kiloGrays (7.5 MRad), the risk of cracking or fractures is reduced compared with a highly cross-linked material.18

To address a growing trend toward high demand patients, ALTRX polyethylene liners reduced wear by 92% in an internal laboratory study versus standard polyethylene and 53% versus MARATHON polyethylene liners.3,18

ALTRX polyethylene is available for PINNACLE cup sizes from and outer diameter of 44 mm onwards.

The internal diameter ranges from 28 mm to 48 mm in line with specific corresponding cups diameters. The ALTRX liners are available in different stability options: neutral, lipped, with 10 degrees of orientation and with 4 mm of extra thickness to adjust offset. Ask your local DePuy Synthes representatives for more information.

CERAMAX

The ceramic material offered with the Pinnacle Hip Solutions is CERAMAX Ceramic, a BIOLOX®delta composite material with a unique combination of toughness and structural integrity. Through an exhaustive process of assessment and testing, CERAMAX Ceramic has been developed to incorporate the best characteristics of ceramics as implant materials. The outcome is a material with the wear behaviour and excellent biocompatibility of alumina, but with improved mechanical properties for use in Ceramic–on–Ceramic joints.9‑11

CERAMAX ceramic-on-ceramic (CoC) combinations are available in a PINNACLE cup from and outer diameter of 44 mm onwards with a 28 mm head and from 52 mm outer diameter onwards with a 36 mm head, either for primary or revision cases.

References

  1. McKellop H, et al.: Development of an Extremely Wear-Resistant Ultra High Molecular Polyethylene for Total Hip Replacements. J Orthop Res 1999; 17(2): 157-166.
  2. McKellop H, et al.: Wear of Gamma-Crosslinked Polyethylene Acetabular Cups against Roughened Femoral Balls. Clin Orthop Rel Res 1999; 369: 73-82.
  3. Liao, Y.-S., Greer K, et al. “Effects of Resin and Dose on Wear and Mechanical Properties of Cross-linked Thermally Stabilized UHMWPE.” Society for Biomaterials, the 7th World Biomaterials Congress, Sydney, Australia, 2004.
  4. Greer K. and Sharp,M. “Comparison of crosslinked UHMWPE stabilized by sequential annealing or by remelting”. Orthopaedic Research Society 53rd Annual Meeting, Transactions Vol.32, Poster #1784, San Diego, CA, 2007.
  5. DePuy Internal Test Report: WR050089; 2004.
  6. DePuy Internal Test Report: WR070074; 2008.
  7. Engh C A et al: A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty 2006; 21(Suppl 2):17-25.
  8. Beaule PE. et al. Jumbo Femoral Head for the Treatment of Recurrent Dislocation Following Total Hip Replacement. J Bone Joint Surg. 2002;84A:256-63.
  9. Rack R and Pfaff HG. A New Material Concept for Bioceramics in Orthopaedics. Proceedings of the 5th International CeramTec Symposium. Thieme Verlag, Stuttgart 2000: 136-140.
  10. Insley GM, Turner I, Fisher J, Streicher RM. In Vitro Testing and Validation of Zirconiatoughened Alumina.In: Bioceramics in Joint Arthroplasty, Garino J and Willmann G, eds, Thieme Verlag, Stuttgart 2002: 26-31.
  11. Burger W et al. High Strength and Toughness Alumina Matrix Composites by Transformation Toughening and 'In Situ' Platelet Reinforcement (ZPTA ) - The New Generation of Bioceramics. Key Eng Mat. 2001;192-195:545-548.
  12. Dowson D et al. A Hip Joint Simulator Study of the Performance of Metal-on-Metal Joints: Part I: The Role Materials. J Arthroplasty. 2004;19(8 Suppl.3):118-123.
  13. Dowson D et al. A Hip Joint Simulator Study of the Performance of Metal-on-Metal Joints: Part II: Design. J Arthroplasty. 2004;19(8 Suppl. 3):124-130.
  14. Calvert et al: A Double-Blind, Prospective, Randomized Controlled Trial Comparing Highly Cross-Linked and Conventional Polyethylene in Primary Total Hip Arthroplasty. J Arthroplasty 2009;24:505-510.
  15. Bitsch RG et al: Reduction of Osteolysis with Use of Marathon Cross- Linked Polyethylene. A Concise Follow-up, at a Minimum of Five Years, of a Previous Report. J Bone Joint Surg Am, 2008;90A:1487-1491.
  16. Mutimer, J., Devane, PA., Adams, K. and Horne, JG. “Highly Crosslinked Polyethylene Reduces Wear in Total Hip Arthroplasty at 5 Years.” Clin Orthop Relat Res 2010;468:3228-3233.
  17. Bitsch RG et al: Reduction of Osteolysis with Use of Marathon Cross- Linked Polyethylene. A Concise Follow-up, at a Minimum of Five Years, of a Previous Report. J Bone Joint Surg Am, 2008;90A:1487-1491.
  18. Data on file at DePuy Orthopaedics, Inc. Report number WR050089, 2004 and WR070074, 2008.
  19. Bedard N, Callaghan J, Stefl M, Williams T, Liu S, Goetz D. Fixation and Wear with Contemporary Acetabular Components and Cross-Linked Polyethylene at 10-Year Follow-Up. Journal of Arthroplasty. 2014; 29: 1961-1969.
  20. Engh CA Jr., Hopper RH Jr., Huynh C, Ho H, Sritulanondha S, Engh CA Sr. A Prospective Randomized Study of Cross-Linked and Non-Cross-Linked Polyethylene for Total Hip Arthroplasty at 10 –Year Follow Up, Journal of Arthroplasty. 2012; 27: (8 Suppl 1) S2-7
  21. Kim YH, Park JW, Patel CP, Kim DY. Polyethylene Wear and Osteolysis After Cementless Total Hip Arthroplasty with Alumina-on-Highly Cross-Linked Polyethylene Bearings in Patients Younger Than Thirty Years of Age. JBJS. 2013; 95: 1088-1093
  22. Liao, Y-S.; Greer, K.; Hanes, M.; McNulty,”Effects of Resin and Dose on Wear and Mechanical Properties of Crosslinked Thermally Stabilized UHMWPE” :DePuy White paper
  23. Liao, Y-S; Alberts, A; Keefer, R; Greer, K ”Effect of Head Size on the Wear of GUR 1050 5-Mrad and GUR 1020 7.5-Mrad Crosslinked- Remelted Polyethylene”: Poster No. 2333 55th Annual Meeting of the Orthopaedic Research Society 2009
  24. Data on file at DePuy Orthopaedics, Inc. Report number WR050089, 2004.