CeramTec Medical Products. BIOLOX DUO Ceramic Bipolar System. Bone-sparing joint reconstruction with a maximum range of motion

Transcription

1 CeramTec Medical Products BIOLOX DUO Ceramic Bipolar System Bone-sparing joint reconstruction with a maximum range of motion

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3 BIOLOX DUO Ceramic Bipolar System Less is more BIOLOX DUO is an alternative to total hip replacement. The self-centering bipolar system leaves the acetabulum intact, thus allowing better proprioception. It provides a very large range of motion. The ceramic-ceramic wear couple drastically reduces polyethylene and metal wear debris. Consequently metal sensitivity and the risk of aseptic loosening due to polyethylene particles are also nearly prevented. The implant is particularly suitable for younger, more active patients and for patients with a sensitivity to metal. BIOLOX DUO combines the proven advantages of a modern bipolar prosthesis with the BIOLOX ceramic wear couple. 3

4 Alternative to Total Hip Replacement Compared with conventional hip replacements a bipolar system offers many important advantages: Conservation of the acetabulum Better proprioception Lower risk of dislocation Possibility of earlier mobilization Reduced surgical trauma Shorter operating time Easier surgical technique Lower risk of complications Faster rehabilitation possible Reduced cost as no acetabular shell is required Wider range of revision options 4

5 BIOLOX DUO permits a high degree of flexion with a lower risk of dislocation. 5

6 Sparing Bone, Protecting Cartilage Conservation of the acetabulum The BIOLOX DUO system is the treatment of choice for hip joint disease in which the acetabulum is intact and worth conserving. It can be used, for example, in the treatment of osteoarthritis, femoral head necrosis or femoral neck fracture. Better proprioception Minimization of surgical trauma to the joint capsule, the limbo and to the acetabulum helps to retain proprioception. This facilitates a rapid return to a physiological gait, along with the clear advantage of load bearing and muscle rehabilitation. Wider range of revision options Conservation of the acetabulum permits a wider range of revision options on the acetabular side and provides a good starting point for a revision operation, should one be needed. This increases the likelihood that the well fixed femoral stem can be left in place during a revision. 6

7 The BIOLOX DUO system is easy to assemble in situ. 7

8 The self-centering principle: The separation of the centers of rotation ensures that the bipolar shell does not tilt into an extreme varus position. Under load the shell gradually returns to its correct position. 8

9 Biomechanically Natural and Safe Stable with lower risk of dislocation The system has been designed to remain centered during normal walking and loading. The majority of the joint motion takes place in the inner bearing, between the ball head and the bipolar shell. Only at the extreme ranges of motion, for example in maximum flexion, will the bipolar shell also move. Under load the shell will gradually return to its neutral position. The extremely low friction of the articulating surface ensures that only a small amount of the motion takes place in the acetabulum, which is well-protected against erosion as a result. The large range of motion provided by the implant reduces the risk of dislocation. 9

10 Lasting Wear Resistance Wear-resistant and biocompatible BIOLOX ceramic is extremely resistant to abrasion and wear, which proves the material s suitability for use in joint replacement. Its advantages are in the bone and soft-tissue sparing design of the BIOLOX DUO system. In both the outer bearing against acetabular cartilage and the inner bearing against ceramic it creates articulations which provide long-term wear-resistance. Surface finish The outer surface of the bipolar shell articulates against the natural acetabulum; the inner surface articulates against the BIOLOX ball head. All of these ceramic surfaces are highly polished and possess extremely low surface roughness (Ra < 0.02 μm). Due to the smoothness of these surfaces and to the formation of an effective lubrication film, ceramic bearings are almost frictionless. 10

11 With conventional wear couples consisting of metal and polyethylene the release of metal ions or a material adverse reaction may occur. Ceramic-on-ceramic is extremely wear-resistant. Material adverse reactions are not known. Metal ion release is below the detection limit of analytical methods and is not clinically significant. Extremely smooth surface of a BIOLOX delta ball head. Source: CeramTec GmbH 11

12 Optimal Lubrication Excellent wettability Hydrogen bonds form between the ceramic surface and the synovial fluid. The excellent wettability of BIOLOX ceramic permits the formation of an effective lubrication film, which continuously maintains a low coefficient of friction. This property optimizes the sliding ability of the inner and outer bearings of the BIOLOX DUO system. Coupled with the self-centering design of the system, this ensures that only a small part of the joint motion is transferred to the acetabulum. Metal: 86 Ceramic: 45 The wetting angle for metal and polyethylene (left) is about twice as large as that for BIOLOX ceramic (right). The smaller the wetting angle, the better the wettability. Source: CeramTec GmbH Source: CeramTec GmbH 12

13 Well-Tolerated by the Human Body Excellent biological behavior In the long-term clinical application no adverse body reactions to ceramic particles are known. Ceramic is bioinert and biocompatible. Clinical results After more than 40 years of clinical use in total hip replacements a large number of long-term clinical reports are available for BIOLOX ceramic. With regards to the solution of the osteolysis problem, BIOLOX ceramic has prevailed as a proven alternative to metal and polyethylene wear couples. The ceramic bearing couples BIOLOX forte / BIOLOX delta have excellent wear properties. This 48 year old female patient suffered from bilateral femoral head necrosis. She was operated on in The picture shows the two BIOLOX DUO systems 11 years after implantation. 13

14 BIOLOX DUO Product Range The BIOLOX DUO system consists of three components which are assembled intraoperatively. A 28 mm BIOLOX forte ball head or a 28 mm BIOLOX delta ball head A BIOLOX forte bipolar shell with outer diameter from 42 mm to 56 mm (in 1 mm increments) A polyethylene fixation ring The BIOLOX DUO system can be combined with all hip stems, which are approved for use with the 28 mm BIOLOX forte ball heads or with the 28 mm BIOLOX delta ball heads. If necessary, the polyethylene fixation ring can be removed easily and the system can be disassembled. More Information More information about the BIOLOX DUO system including ani mated handling instructions and illustrations of biomechanics as well as abrasive and wear processes in hip replacements can be found in the BIOLOX inside App. The App is available in the App Store as well as in Google Play for Android devices. Download the BIOLOX inside App for Windows XP, Vista, 7 or 8, and Apple OS X devices at 14

15 BIOLOX delta BIOLOX forte UHMW-PE 56 15

16 CeraNews App for Apple and Android tablets and smartphones Scan the QR code CeramTec GmbH to learn more about Medical Products Division the BIOLOX DUO CeramTec-Platz 1 9 bipolar system D Plochingen Tel Fax medical_products@ceramtec.de This document is intended exclusively for experts in the field, i.e. physicians in particular, and is expressly not for the information of laypersons. The information on the products and / or procedures contained in this document is of a general nature and does not represent medical advice or recommendations. Since this information does not constitute any diagnostic or therapeutic statement with regard to any individual medical case, individual examination and advising of the respective patient are absolutely necessary and are not replaced by this document in whole or in part. The information contained in this document was gathered and compiled by medical experts and qualified CeramTec employees to the best of their knowledge. The greatest care was taken to ensure the accuracy and ease of understanding of the information used and presented. CeramTec does not assume any liability, however, for the up-to-dateness, accuracy, completeness or quality of the information and excludes any liability for tangible or intangible losses that may be caused by the use of this information. In the event that this document could be construed as an offer at any time, such offer shall not be binding in any event and shall require subsequent confirmation in writing. BIOLOX delta and BIOLOX forte ball heads and BIOLOX DUO are registered by CeramTec s customers. They are not registered / available in all countries. MT EN-01 Printed