The bi-metric XR series of Hip implants blends biomet s proven philosophy and tradition with Advanced technology. porous primary hip series

Transcription

1 The bi-metric XR series of Hip implants blends biomet s proven philosophy and tradition with Advanced technology porous primary hip series

2 BI-METRIC XR SERIES implant technology The Bi-Metric XR Hip Series has been designed to meet the demands of today s active patient. The XR Series is a fusion of sound engineering principals and surgical expertise, utilizing modern manufacturing and implant design technologies. Standard Bi-Metric Stem Bi-Metric XR Stem Polished Neck Surface: Polished neck and shoulder geometry to help reduce the amount of wear on the implant surface. Reduced Tapered Trapezoidal Neck: A shorter Morse-type taper with a trapezoidal neck geometry to reduce the risk of impingement. SPP RPP CDH * Standard (SPP), Reduced (RPP) and CDH profile stems provide for an accurate fit in the proximal femur. The RPP stem is reduced medially 4mm from the SPP stem. Clinically Proven PPS Porous Plasma Spray Coating: 2 4 A titanium alloy substrate combined with non-interconnected, circumferential titanium porous coating has been designed for bony ingrowth to lock in the femoral implant and create a seal to particulate debris migration that may help to reduce osteolysis and improve long-term fixation. 8 *CDH neck not shown in this photo illustration.

3 Bi-Planar Tapered Stem: Biomet s philosophy incorporates a clinically proven 3 bi-planar taper geometry. The stem tapers 3 from the proximal shoulder to the distal tip of the implant and from the lateral shoulder to the medial calcar area. The taper affords greater proximal stress off-loading and minimizes the need to remove distal cortical bone. Each implant s distinct lateral-to-medial taper is designed to provide physiologic proximal load transfer and exceptional implant-to-patient fit. Trapezoidal neck geometry reduces the risk of impingement and provides for an increased range of motion up to 145º using the M 2 a-taper 32mm articulation. Titanium: All Bi-Metric XR Stems are constructed of Ti-6Al-4V titanium alloy to enhance bio-compatibility, high fatigue strength and a low modulus of elasticity º 126.5º Interlok Surface: Provides a roughened titanium surface for bone ongrowth, enhancing the potential for long-term fixation. Increased lateral offset is provided by an option of either a 131.5º or 126.5º neck angle, allowing accurate matching of patient anatomy and improved tissue tension and leg length restoration.

4 BI-METRIC XR SERIES implant technology the XR Series of hip implants is built on the design and long term clinical success of the Bi-metric Stem uncompromised tradition and technology The foundation for the XR Series of implants is the excellent long-term clinical results of proximal-to-distal tapered stem geometries (Figure 1). The 3º bi-planer taper provides physiologic proximal load transfer and preserves distal cortical bone, significantly reducing the likelihood of proximal resorbtion. The Bi-Metric XR family of femoral components uses net-shape forgings and advanced manufacturing technology to optimize the consistency of multiple geometries and configurations. The combined technology and geometries have proven to meet the needs of both the patient and the surgeon for successful cementless hip reconstruction. Meticulous design and superior materials, combined with improved manufacturing techniques, have allowed for advanced concepts in femoral components and instrumentation. Net-shape forging technology results in a consistent and reproducible surgical technique. This advanced net-forging technology provides a more precise envelope for the implant, which has greatly reduced the human variability, or hand polishing, associated with previous manufacturing methods. This technology allows for superior reproduction of the compound angles on the finished implants and has been integral in the development of the highest standards of performance. In addition, net-forgings adhere to the industry s most exacting dimension tolerances, which provide a more consistent broach-to-implant fit. The XR Series implants maximize the effectiveness of net-forging technology while maintaining the specific features that surgeons prefer. Figure 1 The Bi-Metric Porous Hip System is the foundation of the technologically advanced Bi-Metric XR Series Femoral Components. Primary Results at year follow-up/ 100% survivorship in 105 hips 16 No Osteolysis HHS Increased from an Average of 26 Preoperatively to 92 Postoperatively No Revisions 8 11 year follow-up / 100% Aseptic Survivorship in 67 hips 10 3% Thigh Pain 1.5% Osteolysis No Revisions for Aseptic Loosening 5 15 year follow-up of 118 hips 6 No Osteolysis No Thigh Pain 100% Survivorship 2

5 BIOMET innovations: TITANIUM BI-PLANAR TAPER GEOMETRY CIRCUMFERENTIAL PLASMA SPRAY POROUS COATING TOTAL SYSTEM APPROACH Offering a wide range of stem diameters, the Bi-Metric XR femoral components can be combined with all of the Biomet Articulation and Acetabular designs making the XR Series one of the most versatile and comprehensive systems available today. EXACt hip instrumentation Simple Standard Instrument Sets: Incorporating one common set of instruments, the Exact hip instruments are used to implant all Bi-Metric XR Series components (Figure 1). This feature provides the surgeon with maximum flexibility and simplifies procedures for the OR staff while reducing instrument inventory for the hospital. Figure 1 Exact General Instrument Case #1 3

6 BI-METRIC XR SERIES implant technology Figure 1 Above is an SEM photograph at 100x magnification showing PPS plasma spray porous coating. titanium PPS Porous plasma spray Plasma spray is a three-dimensional distribution of randomly dispersed titanium particles (Figure 1). Biomet s proprietary plasma spray application is unique in that only the titanium alloy powder used to create the coating is heated, not the implant s substrate (Figure 2). Plasma spray porous coating is applied to the substrate of the implant at a low temperature, which preserves up to 90% of the mechanical strength of the implant. 2 Randomly shaped particles are flattened upon impact with the substrate. An arbitrary distribution of pore size between 100 and 1,000 microns is generated, providing a larger contact area between the particles and the substrate (Figure 3). The resulting surface is rough in contrast to the smooth surfaces of a beaded implant. stability, interface strength and contact to the bony surface area are maximized by the irregular surface. This feature allows the implant to scrape bone into the pores during implantation, providing solid initial fixation. In addition, the random particle dimensions result in a varied pore size distribution. Smaller pores are important for initial fixation because they can fill in with bone more quickly to help promote early osseointegration. Larger pores require a longer time to fill in and provide for long-term fixation with continued macro bone in-growth. Bony in-growth is important for mechanical interlocking and maximum load transfer. Studies show that rough titanium has been found to have a good propensity for adhesion of osteoblasts. 17 Circumferentially coating the femoral component with plasma spray creates a barrier to particulate debris (metallic, polyethylene or PMMA), which can trigger a macrophage response that can initiate osteolysis. 1,5,9,14 Tanzer, et al., have reported that sealing the endosteum from the pumping of debris may be the most important factor in preventing osteolysis in total hip patients. 18 The lack of longitudinal pore interconnectivity creates a seal from this particulate debris migration, which may help to reduce osteolysis and improve long-term fixation. 7,18 While other femoral components have circumferential porous coating, it is not Biomet s clinically proven non-interconnected plasma spray. 3,7,13 The Bi-Metric XR Series implants offer a variety of surface finishes that promote fixation. Biomet s porous plasma sprayed components have shown significantly lower rates of osteolysis than other circumferentially-coated components. 8,11,12,15,16 Proximal circumferential non-interconnected plasma spray works in conjunction with the implant design for optimal bone ingrowth. A roughened Interlok finish distally provides the medium for bone ongrowth which is consistent with proximal fixation. Figure 2 Titanium PPS Porous Plasma Spray being applied through a heated plasma arc. Fatigue Strength (ksi) at 10 7 Cycles Most pores are large, but a few are small for initial fixation Mixture of large & small pores Most pores are small Substrate Figure 3 Sintered or Diffusion Bonded Ti Alloy Plasma Sprayed Sintered or Diffusion Bonded Range of values determined Range of values reported Co-Cr Alloy Plasma Sprayed Effect of the porous coating method on fatigue strength. 8 4

7 Offset restoration In total hip reconstruction, the most effective and easily manipulated mechanical variable available to the surgeon to optimize the biomechanics of the hip is the offset of the prosthesis. Having the ability to change the offset allows the surgeon to increase joint stability and restore normal hip function. If the potential offset deficiency is not identified or treated, it could lead to joint instability, limp, and increased joint reaction forces. The advantage, intraoperatively, is that it allows for adjustment of offset and soft tissue tension without changing the neck resection level or the length of the leg. In-depth studies have concluded that femurs with greater horizontal offset often have a more varus neck shaft angle. As the stem size increases, the required offset also increases. 4 The Bi-Metric XR component s design is based on this philosophy. The Bi-Metric XR Series implants employ two different femoral neck angles to achieve optimal offset restoration. The standard proximal profile stems (SPP) utilize a 131.5º neck angle and the reduced proximal profile stems (RPP) offer both a 131.5º and 126.5º neck shaft angle to increase offset (Figure 1). These neck angle options combined with seven modular head neck length choices work in unison to promote gradual off-loading of stresses from the femoral component throughout the entire femur. anatomic offsets enhance joint stability and help restore hip biomechanics by providing the opportunity to tighten soft tissue without creating leg length discrepancies Femoral Offset RPP 0mm 4mm 3mm 4mm 126.5º 131.5º 3mm Figure 1: Comparison of head location for XR series RPP stems: Computer model illustrates the +3mm head position on the 126.5º stem is lateralized 4mm from the standard head position on the 131.5º stem. The 126.5º stem with a +3mm head and the 131.5º stem with a standard head have the same vertical offset. 5

8 offset information Bi-Metric XR Series º Reduced Proximal Profile (RPP) Neck Angle (Degrees) Neck Length Horizontal Offset Vertical Offset X X X X X X X X X X Bi-Metric XR Series º Standard Proximal Profile (SPP) Neck Angle (Degrees) Neck Length Horizontal Offset Vertical Offset X X X X X X X X X

9 Bi-Metric XR Series º Reduced Proximal Profile (RPP) Neck Angle (Degrees) Neck Length Horizontal Offset Vertical Offset X X X X X X X X X Bi-Metric XR Series º CDH Neck Angle (Degrees) Neck Length Horizontal Offset Vertical Offset X X X X X X SPP RPP Horizontal Offsets CDH Horizontal Offset Vertical Offsets Vertical Offset Neck Lengths Neck Length 126.5º Neck Angle 131.5º Neck Angle 131.5º Neck Angle Stem Lengths Reduced Proximal Profile (RPP) -4 mm Standard Proximal Profile (SPP) Stem Diameters Stem Diameter SPP = Standard Proximal Profile RPP = Reduced Proximal Profile 7

10 implant and INstrument ordering information Bi-Metric XR Series º Reduced Proximal Profile (RPP) Broach Trunion X X X X X X X X X X X X X X X X X X X X Bi-Metric XR Series º Standard Proximal Profile (SPP) Broach Trunion X X X X X X X X X X X X X X X X X X X X X X X X X X X

11 Bi-Metric XR Series º Reduced Proximal Profile (RPP) Broach Trunion X X X X X X X X X X X X X X X X X X Bi-Metric XR Series º CDH Broach Trunion X X X X X X X X X X X X X X X X X X Bi-Metric XR Instrument Cases Bi-Metric XR CDH Broach/Trunion Case Bi-Metric XR SPP Broach/Trunion Case Bi-Metric XR RPP Broach/Trunion Case Exact Instrument Cases Exact General Case #1 (Insertion Instruments) Exact General Case #2 (Extraction Instruments) Exact Bi-Metric Tapered Reamer Case Bi-Metric XR X-Ray Templates CDH (6mm 11mm) 120% mag SPP/RPP (7mm 16mm) 120% mag CDH (6mm 11mm) 110% mag SPP/RPP (7mm 16mm) 110% mag Additional Instruments Included in Bi-Metric XR Instrument Cases Exact Broach Handle X Femoral Resection Guide X Greater Trochanter Stop 9

12 references & additional support material 1. Anthony, P.; et al.: Localized Endosteal Bone Lysis in Relation to the Femoral Components of Cemented Total Hip Arthroplasties. J. Bone Joint Surg., B: , November, Bourne, R.B.; et al.: Ingrowth Surfaces: Plasma Spray Coating to Titanium Alloy Hip Replacements. CORR, 298: 37 46, Clinical Evaluation of Titanium Alloy Cementless Total Hip Replacement: A 1 5 Year Multi-Center Study. Biomet, Inc., Clinical Report, Davey, J.R.; Tozakoglou, E.: The Role of Lateral Offset Stems. Orthop. Trans., 22(1): 273, DeHeer; et al.: Differential Activation of Macrophages by Wear Debris. Trans. Retrieval Symposium of the Society for Biomaterials, 85, Evans, J.: Outcome of a Tapered, Titanium, Proximal Load-Bearing Non- Cemented Femoral THA Component: A Minimum 5-Year Follow-Up Study. Presented at AAOS, New Orleans, LA, March 19 23, Head, W.C.: Mallory-Head Porous Press-Fit Primary Hip Replacement. Presented at the Tenth Annual International Symposium: New Developments in Total Joint Reconstruction, Lake Tahoe, Nevada, June 14 16, Head, W.C.; Mallory, T.H.; Emerson Jr., R.H.: The Proximal Porous Coating Alternative for Primary Total Hip Arthroplasty. Orthop., 22: 813, Horowitz, S.; et al.: Microphage Exposure to Polymethyl Methacrylate Leads to Mediator Release and Injury. J. Orthop. Research, 9(3): , Jiranek, W.: The Bi-Metric Component at 8 11 Years. Presented at the 98 Harvard Hip Course. 11. Keisu, K.; Orozco, F.; Sharkey, P.; Hozack, W.; Rothman, R.: Primary Cementless Total Hip Arthroplasty in Octogenarians. J. Bone Joint Surg., 83- A: 359, Mallory, T.H.: Minimum 10-Year Results of a Tapered Cementless Femoral Component in Total Hip Arthroplasty. Presented at Festschrift Celebration, May 2001 to be published in J. Arthroplasty. 13. Mallory, T.H.; et al.: Clinical and Radiographic Outcome of a Cementless Titanium Plasma-Spray Coated Total Hip Arthroplasty Femoral Component: Justification for Continuance of Use. Presented at the Annual Meeting of the AAOS, Orlando, FL, February, Maloney, W.; et al.: Fibroblastic Response to Particulate Metallic Debris. Trans. Retrieval Symposium of the Society of Biomaterials, 34, Mauerhan, D.R.; Mesa, J.; Gregory, A.; Mokris, J.: Integral Porous Femoral Stem 5 to 8 Year Follow-up Study. J. of Arthroplasty, 12(3): , Meding, J.B.: Minimum Ten-Year Follow-Up of a Straight-Stemmed, Plasma- Sprayed, Titanium-Alloy, Uncemented Femoral Component. Presented at AAOS, San Francisco, CA, February 28 March 4, Symposium: Porous Coating Methods: The Pro s and Cons. Contemporary Orthop., 27(3): , Tanzer, M.; et al.: The Progression of Femoral Cortical Osteolysis in Association with Total Hip Arthroplasty Without Cements. J. Bone Joint Surg., 74-A: March, This brochure is intended for international use only. Some of the information contained herein may pertain to products, indications for use of products and/or therapies that are available only outside the United States of America and are not cleared or approved for marketing by the United States Food and Drug Administration. This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. M 2 a-taper, Bi-Metric, Bi-Metric XR, Exact, PPS and Interlok are trademarks of Biomet Manufacturing Corp. DrivenByEngineering P.O. Box 587, Warsaw, IN ext Biomet Orthopedics, Inc. All Rights Reserved Form No. Y-INT-091/051506/Japan

13 126.5 º RPP º RPP º SPP º CDH The Bi-Metric XR Hip Series implants offer four distinctive design strategies for restoration of lateral offset.

14 Key Design features: 3 Bi-planar taper provides enhanced proximal stress off-loading and initial implant stability. Forged titanium for better biocompatibility and a lower modulus of elasticity for enhanced load transfer. Standard proximal profile (SPP), reduced proximal profile (RPP) and CDH implant geometries. Two neck angles of 131.5º and 126.5º accommodate more varus neck angles and allow for lateralization and proper joint restoration. Polished proximal geometry for reduced wear on the neck. Reduced trapezoidal neck to increase range of motion and reduce risk of impingement. Manufactured with state-of-the-art solid modeling and net-shaped forgings. The titanium plasma spray porous coating s structure acts as a potential barrier to the migration of particulate debris and provides rotational stability and proven long-term fixation. Seven neck lengths allow for accurate leg length adjustment. Medialization of the insertion hole facilitates implant insertion without interference of the greater trochanter. Exact Instrumentation for intraoperative flexibility.