CeramTec Medical Products. BIOLOX OPTION The First Choice for Hip Revision. With Case Reports

Transcription

1 CeramTec Medical Products BIOLOX OPTION The First Choice for Hip Revision With Case Reports

2 More options with BIOLOX OPTION Implant loosening The increasing numbers in primary arthroplasty, especially in younger patients, has lead to higher percentages of patients needing more than one surgical revision during the course of their lives. Aseptic loosening remains the most common cause of implant failure. The bearing couple is one of the major factors influencing the revision rate. The components most susceptible to wear are those made of polyethylene. Wear-related osteolysis and implant loosening significantly undermine the prospects for long-term implant success. MoP bearing couple after 10 years in vivo showing massive polyethylene wear, damage to the metal cup taper, and metal debris. The patient complained of implant squeaking. Source: CeramTec GmbH 2 Beyond comparison since 1974

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5 Optimized revision strategy The ceramic revision femoral ball head (BIOLOX OPTION) helps to significantly reduce the rate of wear-related osteolysis following revision hip arthroplasty. In the case of an acetabular cup revision, the surgeon has the option to use a CoP, CoXPLE or CoC bearing when a firmly fixed stem remains in situ. Thus, a bearing couple can be implanted that exhibits a Stem in situ after primary surgery (left), revision surgery using the BIOLOX OPTION system (right) Source: OA Dr. H. Hessler, Klinik für Unfall- u. Wiederherstellungschirurgie, Allgemeines Krankenkahus Celle (Germany) greater degree of wear resistance than the bearing couple used for primary hip arthroplasty. BIOLOX OPTION offers a suitable solution in the rare case of ceramic component fracture. More options for primary surgery Correcting neck length. Solving the problem of a damaged stem taper during surgery.* * The stem taper deformations are described in IFU BIOLOX OPTION. Beyond comparison since

6 Material and structure The BIOLOX OPTION system consists of 2 components: a ceramic femoral ball head and a titanium sleeve. The system s neckless design helps to prevent restrictions to range of motion. The titanium alloy TiAl 6 V 4 sleeve (a material well-proven in arthroplasty), compensates for cases of minor damage to the stem taper* and helps to ensure an even load distribution on the inside of the femoral ball head. The femoral ball head is made of the high-performance ceramic 1 The microstructure of BIOLOX delta: platelets with crackstopping function (1), aluminumoxide particle (2), zirconiumoxide particle (3) 3 Source: CeramTec GmbH 2 material BIOLOX delta, which exhibits extraordinarily high fracture strength and fracture toughness. The material s structure is enhanced by two strengthening mechanisms that help to absorb cracking energy and prevent further propagation of microcracks. BIOLOX delta is therefore much more effective than other ceramic materials at resisting and stopping crack propagation. *Greater damages to the stem taper will rule out the use of the BIOLOX OPTION system. The stem taper deformations are described in IFU BIOLOX OPTION. Material combinations From a tribological point of view, BIOLOX OPTION femoral ball heads can be used in combination with BIOLOX forte or BIOLOX delta inserts or with polyethylene or crosslinked polyethylene inserts in corresponding sizes specifically designed and approved/cleared by the authorities for this application. Other combinations of articulating materials are not recommended. 6 Beyond comparison since 1974

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9 Secure taper fixation The femoral ball heads used in the BIOLOX OPTION system were subjected to extensive testing during their development. In addition to the usual strength tests (burst load and fatigue), the system s developers focused on the establishment of a secure fixation of the ceramic femoral ball head on the outside of the sleeve and of the inside of the sleeve on the metal stem. Testing was carried out to establish an optimally secure mechanical fixation (pull-off test and rotation test) and to account for the phenomenon of fretting. On the subject of Fretting Corrosion in metal femoral ball heads, a focus remains on the micro-movements between two metal surfaces. These movements can lead to corrosion in both the wear particles and the newly altered metal surfaces. Such conditions can lead to significantly increased wear in the bearing couple (third-body wear). Some modular bearing systems with large diameter metal-on-metal articulation have exhibited higher than usual revision due to corrosion and metal debris originating from modular metal connections. Our studies address the issue of taper fretting and corrosion for large ceramic bearing with standard and newly designed experimental setup. While large metal diameter heads have been shown to be a cause for failure of THA, our results demonstrate that even large ceramic heads with a metal adapter sleeve have no significant effect on the corrosion of modular taper connections. Beyond comparison since

10 CASE REPORTS OF HIP REVISIONS WITH BIOLOX OPTION by Luigi Zagra, MD 10 Beyond comparison since 1974

11 Case Report Case 1: Revision to CoXPE after acetabular loosening of a MoM THA Source: Courtesy of Luigi Zagra, MD, PhD, CeraNews 2010 p. 20f Diagnosis: 72-year-old female, severe Alzheimer disease, no other co-morbidities. Operated 2 years earlier, left THA with MoM bearing (Fig 1). The patient is painful since the operation, now shows great difficulties in walking with weight bearing. The cup looks completely loose, acetabular osteolysis. Indication for revision of the cup, the stem looking well fixed. The patient is at risk for post-operative dislocation because of the neurological disease (poor compliance) and because of the large diameter metal femoral ball head. For this reason another large femoral ball head or, alternatively, a double-mobility bearing is indicated. Treatment: Postero-lateral approach, cup revision with hemispherical porous cup, size 54 and XPE liner. The stem was absolutely stable and the metal femoral ball head exchanged for a 36mm BIOLOX OPTION femoral ball head with an XL neck. Immediate full weight bearing, no more pain, no dislocations. Membranes with evidence of metallosis were present (Fig. 2). Pre-op X-ray Post-op X-ray 1 2 Source: Courtesy of Luigi Zagra, Beyond MD, PhD, comparison CeraNews since p. 20f 11

12 Case Report Case 2: Revision to CoC after acetabular loosening of a CoP THA Source: Courtesy of Luigi Zagra, MD, PhD, CeraNews 2010 p. 20f Diagnosis: 49-year-old male, 11 years after left THA with 28mm CoP (Fig 1). The hip was painful under full weight bearing. The CT scan clearly showed osteolysis around the screws of the cup and in the proximal part of the femur (Fig 2a 2c). Indication for revision at least of the liner and of the femoral ball head or, preferably, for an exchange of the cup and converting to a hard-on-hard bearing. Treatment: Postero-lateral approach. The cup was not stable, the stem was well fixed. Revision of the cup with a high porosity implant and a CoC BIOLOX delta bearing (36mm BIOLOX OPTION femoral ball head with L neck, Fig. 3). Accurate debridement of the membranes inside the cysts. Pre-op X-ray Post-op X-ray Pre-op CT scan 1 3 2a 2b 2c 12 Source: Courtesy of Luigi Zagra, Beyond MD, comparison PhD, CeraNews since p. 20f

13 Case Report Case 3: Revision to CoP after ceramic fracture Source: Courtesy of Luigi Zagra, MD, PhD, CeraNews 2010 p. 20f Diagnosis: 71-year-old female, 12 years after a right THA with CoC (sandwich ceramic liner). Sudden appearance of noise and hip pain. Fig 1a shows the X-ray one year before the event and Fig 1b the recent X-ray. A CT scan was performed (Fig 2), confirming the fracture of the ceramic liner. Indication for revision as soon as possible, exchange of the liner and probably of the femoral ball head, which is usually damaged in such cases. Treatment: Postero-lateral approach. Removal of all the ceramic fragments and of the rest of the liner (the sandwich is easy to remove with a small chisel). Aggressive debridement of the periarticular soft tissues in order to remove the membranes and all the small ceramic fragments and washings. Removal of the screws from the metal-back of the cup. The cup and the stem look absolutely stable, but the femoral ball head is obviously macroscopically damaged and must be exchanged. Implantation of a PE liner and of a 32mm BIOLOX OPTION femoral ball head, XL neck to improve stability (Fig 3, 4). X-ray one year before the event 1a The red arrow points to ceramic fragments. 1b 2 The CT scan confirms the fracture of the liner The new liner with a BIOLOX OPTION femoral ball head Post-op X-ray 3 4 Source: Courtesy of Luigi Zagra, Beyond MD, comparison PhD, CeraNews since p. 20f 13

14 CASE REPORTS OF HIP REVISIONS WITH BIOLOX OPTION by Fritz Thorey, MD, PhD 14 Beyond comparison since 1974

15 Case Report Case 1: Revision to CoC after acetabular loosening of a CoP THA Source: Courtesy of Fritz Thorey MD, CeraNews 2010 p. 22f Diagnosis: Female patient, 45 years, BMI 27, 7 years after primary THA with acetabuloplasty after dysplastic osteo arthritis, BIOLOX forte femoral ball head (32mm), PE insert, aseptic loosening of the cup (Fig. 1). Treatment: Surgical treatment algorithm for this diagnosis: removal of the cup, synovectomy, removal of possible PE particles, lavage. After revision: threaded cup because of defect at the anterior part of the acetabulum, removal of the screws and lateral bone, BIOLOX forte insert, BIOLOX OPTION femoral ball head (32mm, size M). X-ray after 12-month follow-up, patient is fine (Fig. 2). Pre-op X-ray Post-op X-ray 1 2 Source: Courtesy of Fritz Beyond Thorey MD, comparison CeraNews since p. 22f 15

16 Case Report Case 2: Revision to CoP (dysplasia insert) after repeated dislocations Source: Courtesy of Fritz Thorey MD, CeraNews 2010 p. 22f Diagnosis: Male patient, 76 years, BMI 32, 6 years after primary THA via posterior approach, threaded cup, BIOLOX forte femoral ball head (32mm), BIOLOX forte insert, repeated posterior dislocation of the right hip (Fig. 1). Treatment: Removal of BIOLOX forte femoral ball head and BIOLOX forte insert, implantation of PE insert with posterior shoulder to prevent dislocation. BIOLOX OPTION femoral ball head (32mm, size L). X-ray after 9-month follow-up, patient is fine (Fig. 2). Pre-op X-ray Post-op X-ray Source: Courtesy of Fritz Beyond Thorey MD, comparison CeraNews since p. 22f

17 Case Report Case 3: Revision to short stem implant with CoP after ceramic fracture Source: Courtesy of Fritz Thorey MD, CeraNews 2010 p. 22f Diagnosis: Male patient, 60 years, BMI 29, 14 months after primary THA, short stem, threaded cup, BIOLOX forte insert, BIOLOX forte femoral ball head (32mm) (Fig. 1). Decentration of head center, fracture of insert due to trauma, ceramic particles in hip joint (Fig. 2 u. 3). Treatment: Surgical treatment algorithm for this diagnosis: Removal of all ceramic particles, lavage, fluoroscopy to find most of the particles. Surgical technique and procedure: Synovectomy, if cup is not damaged => ceramic insert, if cup has a small damage => PE insert. After revision: PE insert (Cup remained and taper slightly scratched), BIOLOX OPTION femoral ball head (32mm, size M). Remaining ceramic particles in soft tissue around hip joint. X-ray after 7-month follow-up, patient is fine (Fig. 4 u. 5). Postoperative x-ray after primary surgery Pre-op X-rays X-rays after 7-month follow-up Source: Courtesy of Fritz Beyond Thorey MD, comparison CeraNews since p. 22f 17

18 BIOLOX OPTION Your option To use a CoP, a CoXLPE or a CoC bearing couple in the case of a firmly fixed stem that is to remain in situ* To optimize the bearing couple To offer additional options in primary surgery To opt for an appropriate solution in the rare case of a ceramic component breakage Notice BIOLOX OPTION ball heads and sleeves may only be used in combination with femoral stems and stem tapers specifically designed for this combination by the implant manufacturer in cooperation with CeramTec. Stem taper deformations are described in the IFU of BIOLOX OPTION. Greater damages to the stem taper will rule out the use of the BIOLOX OPTION system. Important: please keep in mind that there is no international standard defining the design of the stem taper or their nomenclature. For this reason ANY reference to stem tapers such as 12/14, 10/12 etc. does not necessarily mean that their design is identical. From the tribological point of view, BIOLOX OPTION ball heads can be used in combination with BIOLOX forte or BIOLOX delta inserts or with polyethylene or crosslinked polyethylene inserts in corresponding sizes specifically designed and approved/cleared by the authorities for this application. Other combinations of articulating materials are not recommended. Regulatory guidelines as well as the instructions for use of the implant manufacturers in this regard must always be followed. * The stem taper deformations are described in IFU BIOLOX OPTION. 18 Beyond comparison since 1974

19 BIOLOX OPTION Product Portfolio BIOLOX OPTION ball heads Inserts: BIOLOX delta Inserts: BIOLOX forte (production only on request) from 28/35 to 28/39 28/37, from 28/41 to 28/52 from 32/39 to 32/52 from 32/41 to 32/52 from 36/44 to 36/52 from 36/48 to 36/52 from 40/48 to 40/52 only in combination with monoblock inserts only in combination with monoblock inserts Inserts: PE / XPE BIOLOX delta BIOLOX forte PE/XPE BIOLOX OPTION ball heads and sleeves Taper Diameter (mm) Taper Angle 8/ / / The BIOLOX OPTION system is available for the sizes in the table. S M L XL Beyond comparison since

20 References: 1. Preuss R, Lars Haeussler K, Flohr M, Streicher RM. Fretting Corrosion and Trunnion Wear - Is it Also a Problem for Sleeved Ceramic Heads? Semin Arthroplasty 2012;23: Literature: Catonné Y, Lazennec JY, Nogier A, Fourniols E, Masson B. Revision strategy after metal on metal THR failure: Conversion to ceramic on ceramic. Benazzo F, Falez F, Dietrich M (eds). Bioceramics and Alternative Bearings in Joint Arthroplasty, Steinkopff Verlag Darmstadt, 2006: Cooper HJ, Della Valle CJ, Berger RA, Tetreault M, Paprosky WG, Sporer SM, Jacobs JJ. Corrosion at the Head-Neck Taper as a Cause for Adverse Local Tissue Reactions after Total Hip Arthroplasty. The Journal of Bone & Joint Surgery 2015;94; online : Flohr M, Preuss R, Streicher RM. Fretting and corrosion testing of sleeved modular ceramic heads under in-vivo like conditions. In: Abstract ed, 2013 Gallo J, Barry GS, Lostak J, Janout M. Advantages and disadvantages of ceramic on ceramic total hip arthroplasty: A review. Biomed Pap Med Fac Univ Palacky Olomouc Czech Republic 2012;156: Güttler T. Experience with BIOLOX OPTION revision heads. In: Benazzo F, Falez F, Dietrich M, eds. Bioceramics and Alternative Bearings in Joint Arthroplasty: Steinkopff Verlag Darmstadt, 2006 Helwig P, Konstantinidis L, Hirschmuller A, Bernstein A, Hauschild O, Sudkamp NP, Ochs BG. Modular sleeves with ceramic heads in isolated acetabular cup revision in younger patients-laboratory and experimental analysis of suitability and clinical outcomes. Int Orthop 2013;37:15-9 Hintner M, Kaddick C, Usbeck S, Scheuber L, Streicher RM What an Orthopedic Surgeon Should Know: Selection of a Bearing Couple in Case of Revision After a Fractured Ceramic Component. Semin Arthroplasty 2012;23: Jack CM, Molloy DO, Walter WL, Zicat BA, Walter WK. The use of ceramic-on-ceramic bearings in isolated revision of the acetabular components. Bone Joint J 2013;95-B:333-8 Kemp MA, Mitra A, da Costa TM, Spencer RF Bearing exchange in the management of pseudotumours. Ann R Coll Surg Engl 2013;95: Kim Y, Kim YH, Hwang KT, Choi IY Isolated acetabular revision with ceramic-on-ceramic bearings using a ceramic head with a metal sleeve. J Arthroplasty 2014;online accepted manuscript. Knahr K, Pospischill M. Revision strategies in total hip arthroplasty with respect to articulation materials. Benazzo F, Falez F, Dietrich M (eds). Bioceramics and Alternative Bearings in Joint Arthroplasty, Steinkopff Verlag, 2006: Knahr K, Pospischill M. Strategies for Head and Inlay Exchange in Revision Hip Arthroplasty. In: Chang JD, Billau K, eds. Bioceramics and Alternative Bearings in Joint Arthroplasty, Steinkopff Verlag, 2007 Lazennec JY, Boyer P, Rousseau MA, Rangel A, Ducat A, Sariali E. Revision Strategy and Clinical Results with Alumina Matrix Composite Revision Ball Heads: A 2 Years Follow-up Preliminary Study. Cobb J (ed). Modern Trends in THA Bearings Material and Clinical Performance, Springer Verlag Berlin Heidelberg, 2010: Lazennec JY, Boyer P, Rousseau MA, Ducat A, Gozalbes V, Rangel A, Cantone Y. Ceramic strategy for cup revisions: minimum 3 year follow-up with alumina matrix composite ball heads and sleeves. In: 12th EFORT Congress Copenhagen, 1-4 June 2011, Abstract 1278 ed, Merkert P. The Concept of CeramTec to Offer Ball Heads Dedicated to Hip Revision Demands. In: Lazennec J, Dietrich M, eds. Bioceramics in Joint Arthroplasty: Steinkopff Verlag, 2004 Mittelmeier W. Interview: Highly Resistant. New option for revision hip surgery. In: CeraNews 2006/01, engl. ed, 2006:4. O Brien ST, Burnell CD, Hedden DR, Brandt JM Abrasive wear and metallosis associated with cross-linked polyethylene in total hip arthroplasty. J Arthroplasty 2013;28: Pignatti G, Stagni C, Dallari D, Bochicchio V, Raimondi A, Giunti A. Modular neck and ceramic on ceramic coupling in revision total hip arthroplasty. Benazzo F, Falez F, Dietrich M (eds). Bioceramics and Alternative Bearings in Joint Arthroplasty, Steinkopff Verlag Darmstadt, 2006: Streicher RM, Flohr M, Preuss R. Frictional Torque and Fretting Corrosion of Large Ceramic Ball Heads used with Titanium Conversion Sleeves. In: 59th ORS 2013, Abstract ed, 2013 Streicher RM, Scheuber L, Flohr M, Preuss R. Fretting und Korrosion - ein Problem beim BIOLOX- OPTION-System? In: CeraNews 2/2013 ed, 2013:18-9. Thorey F, Sakdinakiattikoon M, Thiengwittayaporn S, Windhagen H. Early Results of Revision Hip Arthroplasty Using a Ceramic Revision Ball Head. Semin Arthroplasty 2011;22: Traina F, Tassinari E, De Fine M, Bordini B, Toni A Revision of Ceramic Hip Replacements for Fracture of a Ceramic ComponentAAOS Exhibit Selection. The Journal of Bone and Joint Surgery (American) 2011;93:e147-e149. Whittingham-Jones P, Mann B, Coward P, Hart AJ, Skinner JA Fracture of a ceramic component in total hip replacement. Journal of Bone & Joint Surgery, British Volume 2012;94-B: Yoo JJ, Yoon PW, Lee YK, Koo KH, Yoon KS, Kim HJ Revision total hip arthroplasty using an alumina-on-alumina bearing surface in patients with osteolysis. J Arthroplasty 2013;28: Zywiel MG, Brandt JM, Overgaard CB, Cheung AC, Turgeon TR, Syed KA Fatal cardiomyopathy after revision total hip replacement for fracture of a ceramic liner. Bone Joint J 2013;95-B:31-7. CeraNews App for Apple and Android tablets and smartphones Scan the QR code to learn more about BIOLOX OPTION high performance ceramics CeramTec GmbH Medical Products Division CeramTec-Platz 1 9 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. Some products or combinations are not approved for use in US or other countries. Please ask your Sales Representative if the products are available in your market. (Review: September 2014) MT EN Loopkomm Infomarketing Printed in Germany