Cement Free Total Hip Replacement System Efficacy Innovation
Cement Free Hip System The ABG Cement Free Hip System is one of the foremost ranges of cementless total hip replacement prosthesis. Used extensively throughout the world it has demonstrated excellent and consistent clinical results. 1-6 Design Objectives The aims of the ABGII Hip System are to provide total hip replacement that is: 1. Long Lasting 2. Pain Free 3. Fully Functional 4. Easy to implant successfully These are intended to be achieved by re-establishing physiological load transfer in both the acetabulum and the femur through the ABGII Hip System which provides: Anatomical femoral shape with only proximal fixation Hemispherical acetabular component Titanium alloy Hydroxyapatite coating Clinical Objectives 1. Establish Excellent Primary Stability the stem shape is designed to achieve immediate primary stability. 2. Encourage Secondary Biological Fixation the prosthesis has a unique hydroxyapatite coating. This special coating encourages the formation of a biological bond with the bone and promotes the long-term stability of the implant. 3. Optimise Bone Conservation the ABGII implant, instrumentation and surgical technique intend to allow optimum conservation of bone stock. ABGII Stem and Cup System 3
Cement Free Femoral Component The ABGII femoral component s anatomical shape follows the natural contours of the femur in all three dimensions. This helps establish: Primary Stability the anatomical shape of the femoral stem allows it to adapt to the contours of the femur. Normal Physiological Loading this close three-dimensional conformity with the femur ensures that the load transfer pattern imitates the natural distribution of stress. Bone stress levels are also maintained within physiological limits, as this keeps the bone in the proximal femur healthy and reduces resorption. Proximal Load Transfer The system s biomechanics are designed to be as close as possible to those of the normal femur. To achieve this, the distal part of the stem is made undersized, purposely, and load transfer is only allowed to occur proximally. Distal contact between stem and bone is also avoided. The distal part of the stem is polished to prevent bone ongrowth in the event of any contact. This reduces stress shielding and prevents proximal bone resorption from occurring. Correct Anteversion the 5 anteversion of the neck and the 7 anteversion in the stem s metaphyseal portion help the implant follow the femur s natural form. The re-establishment of normal anatomical loading of healthy bone encourages bone remodelling around the prosthesis. It also prevents bone resorption. As a consequence, healthy bone stock is maintained around the implant long-term and a stable firmlyfixed total hip replacement is achieved. Anatomic load transfer occurs in the metaphysic The ABG design aims to re-establish anatomic load transfer 4
Cement Free Hip System Stem Features TMZF Alloy Further improves stress transfer to the proximal femur over conventional TiAl 6 V 4 alloy. Scales these are incorporated into the stem s anterior, posterior and medial surfaces. They encourage the transmission of vertical loading from the implant to the bone and reduce the dependence on friction at the hydroxyapatite surface. Hydroxyapatite Coating only applied proximally. ABG Stem Range 8 sizes Left and right implants Size (left & right) 1 2 3 4 5 6 7 8 Stem Length (mm) 100 100 110 115 120 125 135 145 Neck Length (mm) 28 28 32 32 34 34 36 38 Distal Diameter (mm) 8.5 8.5 9.0 10 11 12 13 14 Super-Polished Heads Femoral-head quality is critical in reducing material wear in hip prostheses. All Vitallium ABG heads are: Given a super-polished finish Have an average Ra value (Roughness value) of < 0.016µm Three times smoother than heads finished to current ISO standards Alumina Heads A range of Alumina Heads is also available for use with the ABGII. Made of medical grade alumina (ISO 6474), the heads have a standard V40 taper of 5 40' and 11.3mm/12.5mm spigot diameter. The surface finish and sphericity are tightly controlled to tend to provide optimal articulation with the alumina Insert. Super-Polished Heads V40 Alumina Heads 37.2 39.2 42.1 43.4 44.5 47.2 50 53.2 1 2 3 4 5 6 7 8 100 100 Ø8.5 Ø8.5 110 Ø9 115 Ø10 120 125 Ø11 Ø12 135 Ø13 145 Ø14 130 Femoral Stem ABGII Stem Range 5
Acetabular Cup System The principal objectives of the ABGII Cup design are to: 1. Ensure stable fixation coupled with an even transfer of load to the supporting bone. 2. Promote secondary biological bonding between the implant and the surrounding bone. 3. Minimise material wear and debris. The ABGII Cup intends to achieve these objectives as a result of its: Hemispherical Shape preserves bone stock and encourages even transfer of load to the supporting bone. Hydroxyapatite coating encourages strong, biological, secondary fixation. Circular Grooving promotes bone ingrowth. Titanium (TiAl 6 V 4 ) Alloy Shell. Duration Stabilised. Polyethylene reduces wear and increases the insert s strength and durability. ABGII shells are available in two options: ABGII No-Hole Cup The ABGII No-Hole Cup consists of a solid shell without holes. This reduces the number of edges between the shell and the polyethylene cup and reduces potential sources of wear. Rotational stability can be enhanced by means of up to five externally-fixed spikes. Their use is left to the surgeon s discretion. ABGII 5-Hole Cup The ABGII 5-Hole Cup has five clustered screw holes. Fixation is achieved by means of either spikes or screws. Any vacant holes in the cup can be sealed by the surgeon, using the ABG obturator screws. The ABG obturator screw provides a water seal to reduce migration of any wear debris that may exist. ABGII Cup Range 6
The ABGII Insert ABGII Alumina Insert Is made from Duration Stabilised Polyethylene, using standard UHMWPE. The unique packaging protects the polyethylene from oxidation and reduces wear. 9 Has a strong snap-fit locking mechanism. This ensures secure shell fixation. Twelve "scallops" provide extra rotational stability. Is available in different head sizes (22.2mm, 28mm and 32mm). These offer surgeons a wider choice of options. Is available in both standard and hooded versions. The cup insert is manufactured from the current highest purity medical grade alumina (Al 2 O 3 ISO6474), selected for its safe clinical history over 20 years of orthopaedic use and its excellent wear characteristics when combined with an alumina head. Excellent wetting and high scratch resistance result in reduced wear rates. Minimal third body wear helps prevent damage of the bearing. Corrosion resistant and bioinert alumina shows excellent long-term in-vivo stability. Alumina insert range Contains the currently maximum possible thickness of polyethylene with every size. V40 Alumina Heads ABGII Obturator, spike and screw ABGII No-Hole Cup ABGII 5-Hole Cup ABGll Cup Duration stabilised polyethylene Insert 7
The Ceramic on Ceramic Bearing Quality Assurance The alumina has a very fine grain size (< 2 microns) and high density (> 3.96g/cc) which provides excellent mechanical integrity. This is achieved by using high purity alumina powder and by using Hot Isostatic Pressing (HIPping). The micrographs below show the effectiveness of this process at removing residual pores and increasing the final density of the alumina. All batches are strictly checked at all stages: manufacturing, packaging and sterilisation. All cups and heads are also individually mechanically proof tested to ensure that any risk of mechanical failure is minimised. NON-HIP MATERIAL HIP MATERIAL Alumina Insert prior to proof testing Non-HIP material cut in cross section. Area featured was remote from the edge of the sample. Magnification x4000 HIP material cut in cross section. Area featured was close to the sample edge. Magnification x4000 Material Performance Alumina is well reputed as a high performance structural ceramic for engineering bearings. This is because of its intrinsic properties of hardness and potential for a high surface polish. The hardness of alumina is approximately 2000 Vickers, almost 10 times higher than cobalt chrome (350 Vickers). This makes it very abrasion resistant and can be polished to Ra < 0.02 microns. This results in the excellent wear data shown in the graph below. Conventional polyethylene (PE) on ceramic bearings offer historically low wear due to the scratch resistance of ceramic heads. However ceramic on ceramic couples demonstrate dramatic improvements in wear patterns (some 300 times less wear). This low ceramicceramic wear has also been reported in clinical wear measurements 6. Risk of any fracture has been significantly reduced by careful design of the acetabular system and through repeated mechanical testing (both static and fatigue). 3 6 mm /10 cycles (equivalent to 1 year) 40 35 30 25 20 15 10 5 0 Irradiated PE / Metal Irradiated PE / Ceramic Metal / Metal Ceramic / Ceramic 8
The Ceramic on Ceramic Bearing The mechanical relationship between the metal cup and alumina insert is fundamental to the long-term stability of the implant. The ABGII Cup s internal shape has been designed to optimise the overall mechanical strength of the system. The conical junction (Morse taper) of the ABGII aluminaalumina cup enables a direct and secure mechanical fit of the two components. The micro-textured interior cup surface helps to distribute stresses evenly across the metal/alumina interface. The ABGII Cup rim has been designed to be elevated above the alumina insert circumference to protect the ceramic from stem impingement. The contact of the stem with the ceramic insert has been seen as a significant reason for failure of other Ceramic-Ceramic systems. 4,11 The Range Of Motion (R.O.M.) of the system has been optimised and a minimum of 126 is achievable. This is in line with physiological requirements to provide full mobility for the patient. The design of the ABGII Cup prevents any impingement with the alumina insert R.O.M. Cup/Insert Size Selection Five Insert sizes are available for combination with eleven ABGII Ceramic-Ceramic cup sizes. An insert size can be used with more than one cup size as shown below. 28mm Reference 49307037 49307039 49307041 49307048 49307052 Alumina Insert ABGII The ABGII Ceramic-Ceramic System provides a minimum Range of Motion (R.O.M.) of 126 Compatible with ABGII cups Outer Diameter (mm) 46, 48, 50 52, 54 56, 58 60, 62 64, 66 32mm Reference Available in a 49306041 49306048 49306052 Alumina Insert ABGII specific pack N.A. including both Compatible with ABGII cup and insert cups Outer Diameter (mm) 52, 54 56, 58 60, 62 64, 66 9
ABG Clinical and Radiological Results The design of the ABGII Femoral Stem is based on the well established ABG HA-Coated Femoral Stem. Clinical studies of the ABG Hip System show excellent results in both the short and medium term. 1-6 As many as 95% of patients were found to be completely painfree after 6-7 years. In one followup study (at 6-7 years), 98% of the patients achieved Merle d Aubigné scores of 17 or above (18 = maximum score) when assessed for total function. In nearly 95% of cases, radiological analysis of the acetabulum confirmed the presence of normal bone in all zones. These successful outcomes fully support the rationale behind the design of the ABG implant. Radiological analysis of the femur showed cancellous densification occurring in the metaphyseal area (particularly in Gruen zones 2 and 6); minimal proximal bone resorption; the presence of reactive lines (in Gruen zones 3, 4 and 5), and and the absence of radiolucent line at the interface bone/implant in the zones covered by the HA coating. These findings suggest that ABG stems achieve strong proximal fixation with no distal load transfer, resulting in strong healthy bone in the metaphyseal region. Considering the cup side, nothing has been detected on X-rays, with the absence of radiolucent line at the interface bone/implant in the 3 zones of Charnley. ABGII French Clinical Study: Total Merle d Aubigné score for the cup (with Duration PE) at 5 year follow-up (765 cases) 6 X-rays featuring the ABGII cup and stem at 5 years postop 10 ABGII French Clinical Study: Total Merle d Aubigné score for the stem at 5 year follow-up (1364 cases) 6
Densitometry Densitometry analysis of hips implanted with the ABG Hip System, compared with their contralateral hips shows that bone density around the prosthesis remains relatively unchanged compared to the unoperated side (b and d). This demonstrates that the design objectives to establish physiological load transfer have been achieved. Any significant change in load transfer would result in a difference in bone density. 3,12 a Densitometry (Lunar) at 5 years. Comparison with nonoperated opposite side. Metaphyseal region: - 10% calcium loss in the trochanteric region, Zone 1; 25% loss at the calcar, Zone 7-12 - 25% increase in calcium content in Zones 2 and 6 b c d Densitometry (Lunar) at 5 years. Diaphyseal region: - Very little change in Zones 3, 4, and 5 A consecutive study has been realised on the ABGII, comparing it with the original ABG design. This study has shown a substantial improvement of the proximal bone stock preservation (zones 1 and 7), confirming the philosophy behind the design change. 19 Mean perioprosthetic bone loss from baseline for distal, proximal and all Green zones combined 11
Acetabular Components ABGII 5-HOLE CUP 48401042 42MM 48490042 48401044 44MM 48490044 48401046 46MM 48490046 48401048 48MM 48490048 48401050 50MM 48490050 48401052 52MM 48490052 48401054 54MM 48490054 48401056 56MM 48490056 48401058 58MM 48490058 48401060 60MM 48490060 48401062 62MM 48490062 48401064 64MM 48490064 48401066 66MM 48490066 48401068 68MM 48490068 48401070 70MM 48490070 48401072 72MM 48490072 48401074 74MM 48490074 ABGII NO-HOLE CUP 48402042 42MM 48490042 48402044 44MM 48490044 48402046 46MM 48490046 48402048 48MM 48490048 48402050 50MM 48490050 48402052 52MM 48490052 48402054 54MM 48490054 48402056 56MM 48490056 48402058 58MM 48490058 48402060 60MM 48490060 48402062 62MM 48490062 48402064 64MM 48490064 48402066 66MM 48490066 48402068 68MM 48490068 48402070 70MM 48490070 FOR USE WITH ABGII NO-HOLE CUPS CATALOGUE NUMBER 48402008 ABGII NO-HOLE SPIKE FOR USE WITH ABGII 5-HOLE CUPS CATALOGUE NUMBER 48400000 ABG OBTURATOR SCREW 48400007 ABG CUP SPIKE 7MM 48400009 ABG CUP SPIKE 9MM 48406512 ABG CUP SCREW 12MM 48406515 ABG CUP SCREW 15MM 48406520 ABG CUP SCREW 20MM 48406525 ABG CUP SCREW 25MM 48406530 ABG CUP SCREW 30MM 48406535 ABG CUP SCREW 35MM 48406540 ABG CUP SCREW 40MM 48406545 ABG CUP SCREW 45MM 48406550 ABG CUP SCREW 50MM 48406555 ABG CUP SCREW 55MM ABGII INSERTS, DURATION STABILISED UHMWPE (Only for use with ABGII Cups) 22.2MM STANDARD 48442242 42MM 48482242 48442244 44MM 48482244 48442246 46MM 48482246 48442248 48MM 48482248 48442250 50MM 48482250 48442252 52MM 48482252 48442254 54MM 48482254 48442256 56MM 48482256 48442258 58MM 48482258 48442260 60MM 48482260 48442262 62MM 48482262 48442264 64MM 48482264 48442266 66MM 48482266 48442268 68MM 48482268 48442270 70MM 48482270 28MM STANDARD 48442846 46MM 48482846 48442848 48MM 48482848 48442850 50MM 48482850 48442852 52MM 48482852 48442854 54MM 48482854 48442856 56MM 48482856 48442858 58MM 48482858 48442860 60MM 48482860 48442862 62MM 48482862 48442864 64MM 48482864 48442866 66MM 48482866 48442868 68MM 48482868 48442870 70MM 48482870 48442872 72MM 48482872 48442874 74MM 48482874 32MM STANDARD 48443250 50MM 48483250 48443252 52MM 48483252 48443254 54MM 48483254 48443256 56MM 48483256 48443258 58MM 48483258 48443260 60MM 48483260 48443262 62MM 48483262 48443264 64MM 48483264 48443266 66MM 48483266 48443268 68MM 48483268 48443270 70MM 48483270 48443272 72MM 48483272 48443274 74MM 48483274 22.2MM HOODED 48452242 42MM 48492242 48452244 44MM 48492244 48452246 46MM 48492246 48452248 48MM 48492248 48452250 50MM 48492250 48452252 52MM 48492252 48452254 54MM 48492254 48452256 56MM 48492256 48452258 58MM 48492258 48452260 60MM 48492260 48452262 62MM 48492262 48452264 64MM 48492264 48452266 66MM 48492266 48452268 68MM 48492268 48452270 70MM 48492270 28MM HOODED 48452846 46MM 48492846 48452848 48MM 48492848 48452850 50MM 48492850 48452852 52MM 48492852 48452854 54MM 48492854 48452856 56MM 48492856 48452858 58MM 48492858 48452860 60MM 48492860 48452862 62MM 48492862 48452864 64MM 48492864 48452866 66MM 48492866 48452868 68MM 48492868 48452870 70MM 48492870 48452872 72MM 48492872 48452874 74MM 48492874 32MM HOODED 48453250 50MM 48493250 48453252 52MM 48493252 48453254 54MM 48493254 48453256 56MM 48493256 48453258 58MM 48493258 48453260 60MM 48493260 48453262 62MM 48493262 48453264 64MM 48493264 48453266 66MM 48493266 48453268 68MM 48493268 48453270 70MM 48493270 48453272 72MM 48493272 48453274 74MM 48493274 12
ABGII Ceramic-Ceramic Components CUP (CERAMIC) NO HOLE AND HOLED CUPS FOR CERAMIC REFERENCE REFERENCE TRIAL SIZE HOLED NO HOLE 4930-0-046 4930-0-146 4849-0-046 46MM 4930-0-048 4930-0-148 4849-0-048 48MM 4930-0-050 4930-0-150 4849-0-050 50MM 4930-0-052 4930-0-152 4849-0-052 52MM 4930-0-054 4930-0-154 4849-0-054 54MM 4930-0-056 4930-0-156 4849-0-056 56MM 4930-0-058 4930-0-158 4849-0-058 58MM 4930-0-060 4930-0-160 4849-0-060 60MM 4930-0-062 4930-0-162 4849-0-062 62MM 4930-0-064 4930-0-164 4849-0-064 64MM 4930-0-066 4930-0-166 4849-0-066 66MM CERAMIC (ALUMINA) INSERTS 28MM REFERENCE TRIAL SIZE 4930-7-037 4930-5-037 FOR OD 46, 48, 50MM 4930-7-039 4930-5-039 FOR OD 52, 54MM 4930-7-041 4930-5-041 FOR OD 56, 58MM 4930-7-048 4930-5-048 FOR OD 60, 62MM 4930-7-052 4930-5-052 FOR OD 64, 66MM CERAMIC (ALUMINA) INSERTS 32MM REFERENCE TRIAL SIZE 4930-6-041 4930-6-141 FOR OD 56, 58MM 4930-6-048 4930-6-148 FOR OD 60, 62MM 4930-6-052 4930-6-152 FOR OD 64, 66MM 4930-1-152 4930-6-241 FOR OD 52MM (PACK INSERT + HOLED CUP) 4930-2-152 4930-6-241 FOR OD 52MM (PACK INSERT + NON HOLED CUP) 4930-1-154 4930-6-241 FOR OD 54MM (PACK INSERT + HOLED CUP) 4930-2-154 4930-6-241 FOR OD 54MM (PACK INSERT + NON HOLED CUP) Please note that Cr-Co stems such as the EON (127 and 132 ), the Definition PM, the Reliance PF and Reliance CM are not compatible with the ABGII cups with ceramic (alumina) inserts. 13
Femoral Components ABGII FEMORAL STEMS WITH HA COATING LEFT IMPLANT SIZE REFERENCE 48450201 1 48450202 2 48450203 3 48450204 4 48450205 5 48450206 6 48450207 7 48450208 8 HEADS V40 (5 40 ) Vitallium REFERENCE HEAD NECK DIAMETRE DIAMETRE (MM) (MM) 6260-4-122 22.2 0 6260-4-222 22.2 3 6260-5-028 28-4 6260-5-128 28 0 6260-5-228 28 4 6260-5-628 28 6 6260-5-328 28 8* 6260-5-032 32-4 6260-5-132 32 0 6260-5-232 32 4 6260-5-332 32 8* RIGHT IMPLANT SIZE REFERENCE 48450101 1 48450102 2 48450103 3 48450104 4 48450105 5 48450106 6 48450107 7 48450108 8 RETENTIVE TRIAL HEAD REFERENCE DIAMETRE NECK (MM) LENGTH (MM) 62648122 22.2 0 62648222 22.2 +3 62648028 28-4 62648128 28 0 62648228 28 +4 62648628 28 +6 62648328 28 +8 6264928 28-2.7 62648032 32-4 62648132 32 0 62648232 32 +4 62648332 32 +8 Ceramic REFERENCE HEAD NECK DIAMETRE DIAMETRE (MM) (MM) 6565-0-028 28-2.7 6565-0-128 28 0 6565-0-228 28 4 6565-0-032 32-4 6565-0-132 32 0 6565-0-232 32 4 6565-0-036 36-5 6565-0-136 36 0 6565-0-236 36 5 * +8 Heads can be used only with stem sizes 2 to 8. 14
Biography 1. Short-term results of Hydroxyapatite-coated primary total hip arthroplasty. Rossi P, et al. Clinical Orthopaedics. 310: pp 98-102. 1995. 2. Hydroxyapatite-coated hip prostheses. Early results from an international study. Tonino A.J, et al. Clinical Orthopaedics 312: pp 211-225, 1995. 3. ABG Prosthesis - Results at 5 years. Nourissat C, et al. Cahiers d'enseignement de la SOFCOT 50pp 208-219 (French) 1994 or Cahiers d'enseignment de la SOFCOT 51: pp227-238 (English) 1995. 4. The histology of the interface between bone and Hydroxyapatite in the ABG hip prosthesis. Adrey J, et al. Cahiers d'enseignment de la SOFCOT 50 pp 139-147 (French) or Cahiers d'enseignment de la SOFCOT 51: pp 149-157 (English) 1995. 5. ABG Cement free hip international multicentre study 5 year follow up. 1996 Stryker publication. 6. ABG II Cementless system ABG Group data, publication pending. 7. Hydroxyapatite treatment and properties. The P-factors. Doyle C. Cahiers d'enseignment de la SOFCOT 50 pp 26-28 (French) 1994 or Cahiers d'enseignment de la SOFCOT 51: pp 30-32 (English) 1995. 8. TMZF A Beta Titanium Alloy for Orthopaedic Implants. Stryker publication 1996. 9. DURATION A stabilised UHMWPE with superior oxidation, creep and wear resistance - technical development and scientific evaluation. Stryker publication 1996. 10. The Histology around Hydroxyapatite coated Total Hip Implants. Tonino A. Efort Barcelona 97 abstract. 11. Histological analysis of the bone-prosthesis interface after implantation in humans of prostheses coated with Hydroxyapatite. Frassinet P, et al. J Orthop Surg 7: pp246-253, 1993. 12. Bone remodelling around uncemented femoral hip implants with Hydroxyapatite coating. Massari L, et al. Stryker publication 1998. 13. On the Material and Tribology of Alumina-Alumina Coupling for Hip Joint Prostheses - A. Walter - Clinical Orthopaedics and Related Research 282 p31-46, 1992. 14. Role of Ceramic Implants Design & Clinical Success with Total Hip Prosthetic Ceramic-to-Ceramic Bearings - I.C. Clarke - Clinical Orthopaedics and Related Research 282 p. 19-30, September 1992. 15. Analysis of Retrieved Alumina Ceramic Components from Mittelmeier Total Hip Prostheses -J. Nevelos, E. Ingham, C. Doyle, J. Fisher, A. Nevelos - J Biomaterials (20), 1833-1840, 1999. 16. Wear of Ultra-High Molecular Weight Polyethylene Acetabular Cups in a Physiological Hip Joint Simulator in the Anatomical Position using Serum as a Lubricant - R.Y. Bigsby, C.S. Hardaker, J. Fisher - Proc Inst Mech Eng H, 211(3):265-9, 1997. 17. Influence of Acetabular Cup Angle on the Wear of Biolox forte Alumina/Alumina Hip Joints in a Physiological Hip Stimulator - J. Nevelos, E. Ingham, C. Doyle, A. Nevelos, J. Fisher - Trans 45th ORS - USA, 1999. 18. Hip Simulator Wear Evaluation of Metal Total Hip Replacement Systems - V. Krishna Polieni, Aiguo Wang - Cas Stark RD 98-012 - September 3, 1998. 19. The Influence of Implant Design on Periprosthetic Bone, Remodelling of two types of Uncemented HA-Coated Hip Stems. A Two-Year Follow-Up Study using dexa A. Tonino et al Publication pending - 2005. Stryker SA Cité-Centre Grand-Rue 90 1820 Montreux Switzerland t : +41 21 966 12 01 f : +41 21 966 12 00 www.europe.stryker.com http://www.abg2hip.com This document is intended solely for the use of healthcare professionals. The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Products referenced with designation are trademarks of Stryker. Products referenced with designation are registered trademarks of Stryker. Literature Number: ABGBR02E03 MTX/GS 09/06 Copyright 2006 Stryker