Rotating Platform System. Product Rationale

Transcription

1 References 1. Meftah M, Ranawat A, Ranawat C. Ten-Year Follow-up of a Rotating-Platform, Posterior-Stabilised Total Knee Arthroplasty. J Bone Joint Surg Am. 2012; 94: Dalury D, Gonzales R, Adams M, Gruen T, Trier K. Midterm Results with the P.F.C. SIGMA Total Knee Arthroplasty System. J Arthroplasty 2008; 23(2): Buechel Sr FF, Buechel Jr FF, Pappas MJ, D Alessio MS. Twenty-Year Evaluation of Meniscal Bearing and Rotating Platform Knee Replacements. Clin Orthop Relat Res, 2001;388: Zelle J, Van der Zanden AC, De Waal Malefijt M, Verdonschot N. Biomechanical Analysis of Posterior Cruciate Ligament Retaining High Flexion Total Knee Arthroplasty. Clin Biomech. 2009; 24(10): Data on file at Depuy Orthopaedics, Inc. Warsaw. Data from AMTI Knee Simulators (WR: , and ) 6. P.F.C. SIGMA System Technical Monograph. Cat. No DePuy International Ltd: revised 03/ Scott R, Michael J. Balancing the Posterior Cruciate Ligament During Cruciate-Retaining Fixed and Mobile-Bearing Total Knee Arthroplasty. J Arthroplasty 2008; 23: Maniar R, Gupta H, Singh A, Johorey A, Singhi T. Five to Eight Year Results of a Prospective Study in 118 Arthroplasties Using Posterior Stabilised Rotating Platform Knee Implants. J Arthroplasty 2011; 26: SIGMA PS Femoral Component Product Overview. Cat. No DePuy International Ltd: issued 08/ SIGMA CR150 System Technical Monograph. Cat. No DePuy International Ltd: issued 07/ Massin P, Depuy F, Khlifi H, Fornasieri C, De Polignac T, Schifrine P, Farenq C, Mertl P. Does Hyperflex Total Knee Design Improve Postoperative Active Flexion? Orthop Traumatol Surg Res. 2010; 96: SIGMA RPF System Technical Monograph. Cat. No DePuy International Ltd: v Frederick F, Buechel SR F. Long-Term Follow-Up After Mobile Bearing Total Knee Replacement. Clin Orthop Relat Res 2002; 404: McNulty D. The Effect of Cross-Linking Uhmwpe on In-Vitro Wear Results in Fixed and Mobile Bearing Knees. Presented at ASTM Symposium on Cross-Linked and Thermally Treated UHMWPE for Joint Replacement, Nov Incavo S, Ronchetti P, Howe J, Tranowski J. Tibial Plateau Coverage in Total Knee Arthroplasty. Clin Orthop Relat Res 1994; 299: Ostermeier S, Bohnsack M, Hurschler C, Stukenborg-Colsman C. A Rotating Inlay Decreases Contact Pressure on Inlay Post After Posterior Cruciate Substituting Total Knee Arthroplasty. Clin Biomech. 2009; 24: Rotating Platform System Product Rationale This publication is not intended for distribution in the USA. DePuy Orthopaedics EMEA is a trading division of DePuy International Limited. Registered Office: St. Anthony s Road, Leeds LS11 8DT, England Registered in England No DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN USA Tel: +1 (800) Fax: +1 (574) DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (0) Fax: +44 (0) DePuy International Ltd. and DePuy Orthopaedics, Inc All rights reserved version 1 Issued: 07/12 CA: DEPM/ORT/0412/0023

2 SIGMA Rotating Platform System A System of choice. DePuy s philosophy in knee replacement is to provide a system of implant options that specifically match the requirements of each patient. SIGMA High Performance implants are designed to provide high function and low wear options, resulting in successful clinical outcomes and a long implant life. Our experience in total knee replacement is extensive. The long clinical heritage of our SIGMA Knee systems has, over time, allowed us to evaluate and refine the product range. Today, you can choose fixed or mobile, cemented or cementless, low wear solutions, with complete confidence. Efficient, precise and flexible, SIGMA High Performance instruments help to correctly position and balance the knee. You are able to follow your own familiar philosophy that is most appropriate for your patient. With the increasing incidence of revisions, DePuy s modular revision system provides mobile bearings and fixation sleeves to reduce transmission of torsional stress to fixation interfaces and improve axial loading of bone. High Function and Low Wear with Proven Clinical Heritage 1 The outstanding clinical success of the SIGMA RP knee system 1 is the outcome of the unique combination of design principles established in the successful SIGMA FB knee system 2 and the clinically proven leader in mobile bearing design LCS knee system 3 developed in collaboration with leading design surgeons Douglas Dennis, Chitranjan Ranawat, Richard Scott and Thomas Thornhill. With the increasing tribological and functional demands from today s patients, longer lasting knee implants are required. By analysing and refining all of the design attributes that affect wear DePuy has developed a true High Function 4 with Low Wear mobile bearing knee system. 5 The SIGMA RP knee system has evolved to meet the new tribological challenge with the SIGMA CR150 and RPF femoral components, while the clinically proven GVF mildly cross-linked polyethylene inserts¹ and the highly polished mobile bearing cobalt chrome tibial component provide low wear 5 solutions to address the demands of today s young and active patients. The primary SIGMA RP knee system offers a portfolio of choice with Cruciate Retaining, Cruciate Sacrificing and Posterior Stabilised constructs and clinically proven cemented and uncemented fixation. The sigma family continues through a continuum of care to the MBT SIGMA TC3 Revision knee system with metaphyseal sleeves. 2

3 SIGMA RP Cruciate Retaining and Sacrificing Knee System SIGMA RP Posterior Stabilised Knee System SIGMA CR femoral component is clinically proven with 99.6% survivorship at 8 years 2 The evolution of proven geometry, based on the outstanding clinical survivorship of SIGMA CS femoral component: 6, while maintaining the sagittal, coronal and cam geometries of the SIGMA CS femoral component, the SIGMA RP PS implant system is designed with revised trochlear groove transition and smoother implant edges. 9 The SIGMA CR sagittal geometry is built on the P.F.C. femoral component that has been clinically successful since The SIGMA CR femoral component coronal geometry is designed to maintain contact area on articulating tibial insert thereby reducing contact stress on polyethylene insert and reducing the risk of bearing damage. 6 The SIGMA CR fixation lugs on the femoral components are symmetric to all sizes allowing proper sizing of the femoral components in the anterior/posterior and assists gaining equal flexion and extension gaps. 6 Clinically proven single radius deep conforming long trochlear groove articulating with a matching spherical radius domed patellar implant. 6 The blending radii around the medial and lateral edges of the SIGMA CR like all SIGMA family femoral components have been designed to provide a smooth soft tissue transition reducing the incidence of soft tissue impingement. The SIGMA primary PS femoral components feature a closed box design allowing attachment point for stems and sleeves extension when needed in complex primary surgeries. 6 SIGMA PS femoral component features increased sagittal and coronal radii in transition from the anterior flange to the box designed to enhance patellar tracking during flexion whilst reducing the risk of soft tissue impingement and associated patellar crepitus. 9 The SIGMA PS femoral component is available in lugged version to aid anterior/posterior placement and non-lugged version to accommodate distal and posterior femoral augments for complex primary surgeries. SIGMA RP Stabilised (STB) inserts rotate around a central stem location, minimising rotational constraint and maintaining cam-post congruency with SIGMA PS femoral component idependent of tibial tray placement. Flexibility as a clinically proven Cruciate Retaining or Sacrificing construct

4 SIGMA CR150 RP Cruciate Retaining and Sacrificing High Function Knee System SIGMA RPF Posterior Stabilised Flexion Knee System The evolution of proven geometry, based on the outstanding clinical success of SIGMA CR femoral component 2, the SIGMA CR150 with RP bearing system delivers a High Performance construct that accommodates safe deep flexion up to 150 degrees in both PCL Retaining and Sacrificing constructs, to deliver a true high function, low wear construct. 4 Based on clinically proven SIGMA CR J-Curve geometry, the SIGMA CR150 femur provides the equivalent component articulation in gait up to 120 degrees, with proven component congruency and effective load transfer. 10 The Clinically Proven SIGMA RPF femoral component 11 features traditional SIGMA J-Curve up to 100 degrees of flexion, then an extended sagittal curve to increase posterior condyle contact area in deep knee flexion. This feature results in an increased posterior condyle cut which is necessary to extend the curve of the implant and allow increased contact area between the posterior condyles and tibial insert providing conforming contact in deep flexion up to 155 degrees. 12 Conforming cam and post functions as third weight-bearing condyle to increase contact area and reduce stress in deep flexion. 12 At 135 degrees of flexion the SIGMA CR150 knee system provides a 31% increase in contact area resulting in a 19% decrease in contact stress compared to SIGMA CR helping to protect the tibial insert and reduce polyethylene damage. 10 The clinically proven SIGMA J-Curve provides curve-on-curve contact while the extended posterior J-Curve, assures conforming contact through 150 degrees of flexion, reducing the risk of point contact stress. 10 SIGMA RP Curved (CVD) inserts rotate around a central stem location, minimising constraint and enabling congruency with SIGMA CR150 femoral component independent of tibial tray placement leading to maximum OR flexibility as a Cruciate Retaining or Sacrificing construct. 7 The optimised size, shape and posterior position of the post promotes increased femoral rollback into flexion. 12 The Polyethylene insert is fully supported by the tibial tray accommodating up to 20 degrees of internal/external rotation without anterior or medial/lateral over hang at 155 degrees of flexion. 12 The rounded coronal articulating geometry is designed to resist lift-off up to 3 degrees, preventing edge loading and peak stress that can result in high flexion. 6 The SIGMA RPF Polyethylene insert post is reinforced with a cobalt chrome pin to ensure transfer of the shear stress from the post of the insert through the cone into the tibial tray

5 SIGMA RP Uncemented Fixation POROCOAT SIGMA RP Clinically Proven GVF Polyethylene Built on the proven geometry of the clinically proven SIGMA CR femoral component² and SIGMA RP mobile bearing tray 9 with POROCOAT at the implant bone interface. The rotational freedom provided by the mobile bearing tray diffuses shear and torsion forces reducing stress on implant fixation points and polyethylene wear. 6 The beaded technology of the POROCOAT coating provides an initial scratch-fit at the host bone implant interface, for implant stability and extensive bone tissue in growth. The unidirectional motion pattern produced by DePuy s rotating platform designs reduces wear by 94% when compared to a competitor fixed bearing device. 14 SIGMA RP uncemented components use the 20 year clinically proven POROCOAT technology 13 ensuring excellent initial and long-term fixation with a structure that is optimal to bone in growth. 13 SIGMA RP Curved (CVD) inserts rotate around a central stem location, minimising constraint and enabling congruency with SIGMA CR POROCOAT femoral component independent of tibial tray placement leading to maximum OR versatility as a Cruciate Retaining or Sacrificing implant. 7 The unique GVF polyethylene provides wear resistance for mobile bearing s unidirectional motion. 14 The 4 Mrad irradiation dose provides mild cross-linking, while the patented vacuum foil packaging promotes hydrogen recombination and can protect from oxidation ensuring excellent clinical performance. 1 POROCOAT uncemented coating is offered in the SIGMA CR, Mobile Bearing keeled and coned versions which could be utilised as a Cruciate Retaining or Sacrificing construct

6 SIGMA RP Mobile Bearing Tibial Tray Symmetrical tibial tray design to provide the maximum bone coverage on the proximal tibial cut. 15 With the tibial insert size matching the femoral component size the SIGMA RP tibial tray can be positioned for maximum coverage on the tibial plateau for each individual patient. With the SIGMA RP cone in cone design, the insert is free to rotate in the tibial tray thus disconnecting the torsional forces and protecting the tibial fixation. 16 Highly polished cobalt chrome tibial tray allows the insert to articulate freely and reduces abrasive wear on the insert backside. 14 One central stem location to accommodate SIGMA RP CVD, STB and RPF tibial inserts available with keeled and coned versions in both cemented and uncemented POROCOAT fixation options. 9 10