T.O.P. Acetabular Cup System

Transcription

1 T.O.P. Acetabular Cup System

2 Presented by: Waldemar Link GmbH & Co. KG Barkhausenweg Hamburg, Germany P.O. Box Hamburg, Germany Tel.: Fax:

3 Contents T.O.P. Acetabular Cup System 02 System Description 03 T.O.P. Acetabular Cup System 04 X-LINKed Polyethylene 05 Implants 05 Metal Casings 06 T.O.P. Polyethylene Inserts UHMWPE 07 T.O.P. Polyethylene Inserts X-LINKed 08 Prosthesis Heads A: BIOLOX * Ceramic 08 Prosthesis Heads B: CoCrMo 09 Instruments 09 Instrument Set for T.O.P. Acetabular Cups 12 Complementary Instrument Set for T.O.P. Acetabular Cups 15 Complementary Instrument Set for Inserter-Positioner 16 Complementary Instrument Set for LINK Acetabular Reamer 17 Surgical Technique 17 Preoperative Planning 18 Surgical Approaches 19 Preparation and Implantation 23 Accessories 23 X-ray Templates 24 Literature 25 Indications/Contraindications 26 Index Important Information *BIOLOX delta and forte are made by CeramTec GmbH, Plochingen, Germany 01

4 System Description System Description The LINK T.O.P. * Acetabular Prosthesis System was especially designed for biologically young, active patients and is the latest generation in cementless pressfit acetabular cups. Many years of experience with successful implant systems and fixation concepts as well as the latest material and coating technologies have been taken into account and used in the design of this innovative acetabular system. in standard and anti-luxation designs. Both variants therefore offer 5 grooves which enable individual alignment appropriate for every hip situation. The T.O.P. Acetabular Cup System is available in microporous primary fixation surfaces and together with the osteoconductive HX calcium phosphate coating (CaP). Due to this, optimum primary and secondary stability of the implant is possible. The mediocaudal recess protects the femoral nerve and psoas tendon whilst ensuring a wide range of movement. The UHMWPE inserts are available *Trabeculae Oriented Pattern HX Coating (calcium phosphate) vertical, crystalline coating structure IIIIIIIIIIIIIIIIIIIIIIIIIIIII IIIIIIIIIIIIIIIIIIIIIII IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII approx. 15 µm Substrate The HX Coating is an osteoconductive coating approximately 15 μm thick. The unique electrochemical coating process results in extraordinary mechanical strength of the coating, that enables it to endure the stress of implantation. The porous cell structure of approx. 160 μm on the substrate s surface is retained open, due to the thin overcoat and provides an optimal environment for osteoconduction. 02

5 System Description T.O.P. Acetabular Cup System Press-fit fixation with maximum bone contact Circular segmental rows of teeth at the cup equator increase primary stability Metal casing with pre-drilled holes for additional screw fixation Mediocaudal recess allows wider range of motion and protects the psoas tendon and femoral nerve Secure fixation of polyethylene insert to metal casing by a snap-lock mechanism T.O.P. polyethylene insert can reduce the risk of femoral head dislocation when the metal casing is placed at a steep angle, for maximum bone contact Standard polyethylene insert is used for normal position of metal casing Metal casing of titanium alloy Polyethylene inserts of UHMWPE and X-LINKed 03

6 System Description Contra-/Indications X-LINKed - highly crosslinked Polyethylene for Acetabular Cups and Inserts The LINK Acetabular Cup Portfolio covers a wide range of indications for acetabular treatment. LINK Acetabular Cups are used in many cases for both biologically young and active patients as well as older patients or in the field of surgical revision. In order to increase the range of movement and optimize joint stability, prosthesis heads with a diameter of up to 36 mm can be used with cups made from X-LINKed Polyethylene. By using X-LINKed Polyethylene, abrasive wear can be reduced significantly which can have a positive effect on the service life of the implant components. X-LINKed Polyethylene is available for following acetabular cup systems: Cementless fixation T.O.P. polyethylene inserts BetaCup polyethylene inserts Cementable fixation Lubinus Eccentric/Dysplastic Polyethylene Acetabular Cup, without snap fit IP Polyethylene Acetabular Cup FAL Polyethylene Acetabular Cup, anti-luxation option Indications/Contraindications Note: For specific indications/contraindications, see page

7 Implants Metal Casings with medio-ventral recess, incl. 2 peep-hole locking screws and 4 screw-hole plugs Material: and HX Coating (calcium phosphate) Metal casings Item no. Outer Ø mm UHMWPE X-LINKed UHMWPE/ X-LINKed Polyethylene inserts for head Ø mm *These inserts show a reduced range of motion and therefore a potentially higher risk of luxation **Only X-LINKed UHMWPE/ X-LINKed X-LINKed / * / * / * 28** / / ** / ** / / / / / / / / / Fixation Screws for metal casings Material: Peep-hole locking screw for metal casing, 1 pc Material: Item no. Ø x length mm /15 5 x /20 5 x /25 5 x /30 5 x 30 05

8 Implants T.O.P. UHMWPE Inserts UHMWPE anti-luxation Material: UHMWPE Inner Ø For metal casings outer Ø mm Item no. Inner Ø mm Item no. Inner Ø mm 40* /40* # /42* /44* / / / / / / / / / / / / / / / / / / / / /68 32 standard Material: UHMWPE Inner Ø For metal casings outer Ø mm Item no. Inner Ø mm Item no. Inner Ø mm 40* /40* # /42* /44* / / / / / / / / / / / / / / / / / / / / /68 32 *These inserts show a reduced range of motion and therefore a potentially higher risk of luxation # Material wall thickness smaller than 5 mm 06

9 Implants T.O.P. UHMWPE Inserts X-LINKed anti-luxation Material: UHMWPE X-LINKed Inner Ø For metal casings outer Ø mm Item no. Inner Ø mm Item no. Inner Ø mm Item no. Inner Ø mm / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /68 36 standard Material: UHMWPE X-LINKed Inner Ø For metal casings outer Ø mm Item no. Inner Ø mm Item no. Inner Ø mm Item no. Inner Ø mm / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

10 Implants Prosthesis Heads Prosthesis heads A Material: BIOLOX forte* ceramic Item no. Head Ø mm Taper mm Neck length mm / /14 short / /14 medium / /14 long / /14 short / /14 medium / /14 long / /14 short / /14 medium / /14 long +4.0 Prosthesis heads A Material: BIOLOX delta* ceramic All components of BIOLOX forte* and BIOLOX delta* are compatible with each other. Item no. Head Ø mm Taper mm Neck length mm / /14 short / /14 medium / /14 long / /14 short / /14 medium / /14 long /04** 32 12/14 extra long / /14 short / /14 medium / /14 long /04** 36 12/14 extra long +8.0 *BIOLOX delta and BIOLOX forte are made by CeramTec GmbH, Plochingen, Germany Prosthesis heads B Material: CoCrMo alloy Item no. Head Ø mm Taper mm Neck length mm / /14 short / /14 medium / /14 short / /14 medium / /14 short / /14 medium / /14 long /04** 28 12/14 extra long / /14 short / /14 medium / /14 long /04** 32 12/14 extra long / /14 short / /14 medium / /14 long /04** 36 12/14 extra long +8.0 **On request 08

11 Instruments Instrument Set for T.O.P. Acetabular Cups Item no. Instrument Set for T.O.P. Acetabular Cup System, complete, for heads Ø 24 and 28 mm /01 Set in standard containers N21 on 2 trays with product illustrations and storage racks /03 Standard container N21, empty, 575 x 275 x 130 mm, aluminium lid and closed base, incl. 5 disposable filters and 10 disposable seals /01 Upper tray, empty, perforated stainless steel, 550 x 265 x 50 mm /01 Lower tray, empty, perforated stainless steel, 550 x 265 x 50 mm X-LINKed Item no. Instrument Set for T.O.P. Acetabular Cup System, complete, for heads Ø 22 und 28 mm /02 Set in standard containers N21 on 2 trays with product illustrations and storage racks UHMWPE /03 Standard container N21, empty, 575 x 275 x 130 mm, aluminium lid and closed base, incl. 5 disposable filters and 10 disposable seals /01 Upper tray, empty, perforated stainless steel, 550 x 265 x 50 mm /01 Lower tray, empty, perforated stainless steel, 550 x 265 x 50 mm 09

12 Instruments /01 Upper tray, empty, perforated stainless steel, 550 x 265 x 50 mm Hex screwdriver, hex width 3.5 mm, 250 mm /02 Impactor handle for T.O.P. metal casings (for use right and left), 375 mm consisting of: Alignment rod 45º straight 120 mm Alignment rod 55º angled 120 mm Pendulum - Positioning guide for pendulum 70 mm Hex screwdriver for peep-hole locking screw of metal casing, hex width 2.5 mm, 240 mm Inserter positioner for polyethylene inserts* UHMWPE (for /02) X-LINKed (for /01) Item no. Inner Ø mm Length mm Item no. Inner Ø mm Length mm / / / / Impactor plates fitting on impactor handle for metal casings Item no. Diameter mm Item no. Diameter mm / / / / / / / / / / / / / / /54 54 *Dismantling ring, see complementary instrument set page 15 10

13 Instruments /01 Lower tray, empty, perforated stainless steel, 550 x 265 x 50 mm Handle for cup trials, 360 mm Cup trials for metal casings Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / / / / / / / /54 54 Trial inserts standard, corr. to polyethylene insert Item no. Inner Ø mm Outer Ø mm Item no. Inner Ø mm Outer Ø mm /40* / /42* / /44* / /40** / /42** / /44** / / / / / / / Trial inserts anti-luxation, corr. to polyethylene insert Item no. Inner Ø mm Outer Ø mm Item no. Inner Ø mm Outer Ø mm /40* / /42* / /44* / /40** / /42** / /44** / / / / / / / *Contained in the instrument set for UHMWPE ( /02) **Contained in the instrument set for X-LINKed PE ( /01) 11

14 Instruments Complementary Instrument Set for T.O.P. Acetabular Cups Trial inserts, inner diameter 32 mm UHMWPE Item no. Complementary Instrument Set, complete, trial inserts inner Ø 32 mm /10 Set in standard container N11, on a tray with product illustrations and storage racks /03 Standard container N11, empty, 575 x 275 x 100 mm /21 Tray, empty, 550 x 265 x 50 mm /32 Inserter-Positioner for acetabular cups, 460 mm, for 32 mm Trial inserts standard, corr. to polyethylene insert, inner Ø 32 mm Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / /60 60 Trial inserts anti-luxation, corr. to polyethylene insert, inner Ø 32 mm Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / /

15 Instruments Complementary Instrument Set for T.O.P. Acetabular Cups Trial inserts, inner diameter 32 mm X-LINKed Item no. Complementary Instrument Set, complete, trial inserts inner Ø 32 mm /15 Set in standard container N11, on a tray with product illustrations and storage racks /03 Standard container N11, empty, 575 x 275 x 100 mm /16 Tray, empty, 550 x 265 x 50 mm /32 Inserter-Positioner for acetabular cups, 460 mm, for 32 mm Trial inserts standard, corr. to polyethylene insert, inner Ø 32 mm Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / / / /58 58 Trial inserts anti-luxation, corr. to polyethylene insert, inner Ø 32 mm Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / / / /

16 Instruments Complementary Instrument Set for T.O.P. Acetabular Cups Trial inserts, inner diameter 36 mm X-LINKed Item no. Complementary Instrument Set, complete, trial inserts inner Ø 36 mm /20 Set in standard container N11, on a tray with product illustrations and storage racks /03 Standard container N11, empty, 575 x 275 x 100 mm /21 Tray, empty, 550 x 265 x 50 mm /36 Inserter-Positioner for acetabular cups, 460 mm, for 36 mm Trial inserts standard, corr. to polyethylene insert, inner Ø 36 mm Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / /60 60 Trial inserts anti-luxation, corr. to polyethylene insert, inner Ø 36 mm Item no. Outer Ø mm Item no. Outer Ø mm / / / / / / / / /

17 Instruments Complementary Instrument Set for T.O.P. Acetabular Cups Item no. Complete Complementary Instrument Set for Anchoring Screws /01 Set in semi-container H11, on a tray with product illustrations and storage racks /03 Semi-container H11, empty, stainless steel, 275 x 275 x 100 mm /02 Tray, empty, perforated stainless steel, 265 x 265 x 50 mm /01 Flexible drill for anchoring screws: mm, Ø 3.2 mm 160 mm, Jacobs Chuck fitting /02 Flexible drill for anchoring screws: mm, Ø 3.2 mm 170 mm, Jacobs Chuck fitting /05 Drill guide, for flexible drills, 290 mm /02 Hex screwdriver, flexible, for anchoring screws, hex width 3.5 mm, 290 mm Complementary Instrument Set for Inserter-Positioner Item no. Dismantling ring For inserter-positioner /11 head Ø 22 mm / /12 head Ø 24 mm / /14 head Ø 28 mm / /15 head Ø 32 mm / /16 head Ø 36 mm /36 15

18 Instruments Complementary Instrument Set for LINK Acetabular Reamers Item no. Complete Complementary Instrument Set Acetabular Reamers /22 Set in standard container N11, on a tray with product illustrations and storage racks /03 Standard container N11, empty, 575 x 275 x 100 mm /14 Tray, empty, 550 x 265 x 50 mm B* Shaft with handle for acetabular reamer, 312 mm, fittings optional Acetabular reamer heads, interchangeable Item no. Reamer Ø mm Item no. Reamer Ø mm / / / / / / / / / / / / / / / / /01 Handle for B-H, fittings optional *How to order: E = with Jacobs Chuck fitting B C D E H Hudson Harris AO Jacobs Chuck Zimmer 16

19 Surgical Technique Preoperative Planning To ensure the best possible treatment results, the appropriate implant should be selected during preoperative planning. Special T.O.P. X-ray templates are available in standard 1.1:1. Together with an up-to-date plain X-ray of the pelvis, the X-ray templates are a practical aid to enable determination of the surgical intervention and of the correct implant size. The aim of preoperative planning is to establish the approximate size of the implant required and the optimal position in which to place it. Surgical complications should be avoided by means of careful planning. In principle, a load-bearing, stable acetabular fossa and solid lateral osseous coverage is desirable. To achieve a press-fit with primary stability, the osseous circumference of the acetabulum must be well preserved. The inclination of the shell should not be significantly above or below 45. The anteversion should not be significantly above or below 15. Placement outside of these boundaries will result in reduced range of motion and could subsequently lead to subluxation and/or dislocation of the joint. 17

20 Surgical Technique Surgical Approaches The choice depends on the surgeon s experience and his/her decision based on the individual situation. The following approaches are common: antero-lateral Watson Jones (A) direct lateral Hardinge (B) postero-lateral Moore (C) A: Watson Jones B: Hardinge C: Moore 18

21 Surgical Technique Preparation and Implantation 1 Dislocation of the Hip Joint After dislocation of the femoral head, the femoral neck and the proximal rim of both trochanters are exposed and existing osteophytes of the femoral head removed. 2 and 3 Femoral Head Resection During the preoperative planning the osteotomy site is determined by applying tangents as shown in illustrations (3). The line of the resection on the isthmus corresponds to the line connecting the intersections points of the tangents. The distance from the base of the major trochanter is usually 1.5 cm. 1.5 cm 19

22 Surgical Technique 4 Exposure and Reaming of Acetabulum Depending on the approach used, the leg is turned so that the acetabulum is well exposed. The initial reamer size corresponds to the width of the acetabular cup entrance. Then reamers with increasing diameters are applied until areas of bloody subchondral compacta become visible but without compromising the supportive structure for secure anchoring of the metal casing. It is essential to keep the reamer head absolutely steady. 5 Determination of Cup Size The cup trial is used to determine the size of metal casing required as the reamed cavity may be larger than was originally intended. As soon as the cup trial is firmly seated in the reamed acetabulum the corresponding size of the metal casing is to be selected. The metal casings are 2 mm larger than the corresponding reamer resulting in a stable press-fit. If bone quality is poor the surgeon may choose a cup diameter that is 2 mm larger for secure anchorage. 6 Implantation of Metal Casing The metal casing is attached to the appropriate impactor plate, which is fixed to the impactor handle, and driven into the prepared acetabulum. The rim of the casing should be parallel to the acetabular entrance plane for secure seating in the surrounding bone. 20

23 Surgical Technique 7 Positioning of the Metal Casing The metal casing is aligned for 45 or 55 cup inclinations using an alignment rod which must be attached to the impactor handle. The alignment rod is at an angle of 90 to the body s axis in each case. To achieve 15 anteversion a positioning guide T with pendulum S is available for patients in a supine position (T parallel to S). For patients in a lateral position the impactor handle should be moved 15 in a ventral direction. T S Alignment rods exchangable Attention: The entrance plane of the acetabulum and the position of the implanted metal casing determine the choice of UHMWPE insert. An entrance angle of approx. 55 requires a T.O.P. anti-luxation insert. A standard insert must be chosen, however, if the angle is approx. 45 in order to avoid impingement during abduction. 8 Closure of the Peep-Hole Locking Screw After impaction the central hole is closed with the peep-hole locking screw. If additional bone screws are used the locking screws must first be removed from inside the cup. 21

24 Surgical Technique 9 and 10 Trial Reduction The plastic trial insert is placed in the metal casing. The pin at the upper rim of the metal casing fits into one of the five notches of the plastic trial insert. Its position depends on the individual case. In a normal case, the pin is placed in the central notch. The trial reduction indicates the correct positioning of the trial insert and the head-neck length. 11 T.O.P. Polyethylene Insert After removal of the bone compressor the T.O.P. insert (or standard insert) is impacted according to the position determined during the trial reduction. The pin secures the cup against rotation. 12 The T.O.P. Acetabular Cup in situ. 22

25 Accessories X-ray Templates Item no / /01 X-ray templates for T.O.P. Acetabular Cup System Tilastan, cementless, 110% actual size, 2 sheets for polyethylene inserts standard outer Ø mm, head Ø mm für polyethylene inserts standard outer Ø mm, head Ø mm UHMWPE X-LINKed Item no / /02 X-ray templates for T.O.P. Acetabular Cup System Tilastan, cementless, 110% actual size, 2 sheets for polyethylene inserts anti-luxation outer Ø mm, head Ø mm for polyethylene inserts anti-luxation outer Ø mm, head Ø mm UHMWPE X-LINKed Instructions for Cleaning and Maintenance Specific instructions for instruments are available on request from customer@linkhh.de 23

26 Literature Literature C.F.P. Hip Prosthesis System Catalog: 671en Lubinus SP II Catalog: 642en 24

27 Indications/Contraindications Acetabular Cup Prosthesis Heads Products T.O.P. Acetabular Cup System BIOLOX forte* + delta* Prosthesis Heads A Prosthesis Heads B General Indications Mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures X X X Indications Primary and secondary coxarthrosis X X X Osteoarthritis X X X Necrosis of the femoral head X X X Femoral neck fractures X X X Revision after implant loosening X* X X Contraindications Poor general state of health X X X Acute and chronic infections, local and systemic X X X Allergies to (implant) materials X X X Distinctive muscular-, nerve-, vascular or other diseases which put the affected limb at risk X X X Insufficient/inadequate bone mass- or quality which prevents a stable anchor of the prosthesis X X X Acetabulum fracture X Relative Contraindications Adiposity X X X Lacking or foreseeable not assured compliance X X X Foreseeable overload/overstressing of the joint prosthesis X X X Osteoporosis X Acetabular defects X *Dependent on bone condition Please note: These indications/contraindications refer to standard cases. The ultimate decision on whether or not an implant is suitable for a patient must be made by the surgeon based on his/her individual analysis and his/her experience. *BIOLOX delta and BIOLOX forte are made by CeramTec GmbH, Plochingen, Germany 25

28 Index Numerical Index... page / / , 13, 14, / /40, / /44 to / /48 to / /52 to / /40, / /44 to / /48 to / /52 to / /01 to / /01 to / /01 to / /01, / /01, / /01 to / /01 to / /01 to / /01 to / /01 to / /01 to / /11 to / /22 to / / , / /38 to / / B-H /01, / / / page / / / / / / / , / , / , /40 to / /40 to / /48, / /52 to / , /52 to / /40 to / /40 to / /48, / /52 to / , /52 to / / /40 to / /40 to / / / / / /15 to / /40 to / /46 to / /52 to / /40 to / /01, / /01, / /40 to / /46 to / /52 to /

29 27

30 28

31 Important Information Please note the following regarding the use of our implants: 1. Choosing the right implant is very important. The size and shape of the human bone determine the size and shape of the implant and also limit the load capacity. Implants are not designed to withstand unlimited physical stress. Demands should not exceed normal functional loads. 2. Correct handling of the implant is very important. Under no circumstances should the shape of a finished implant be altered, as this shortens its life span. Our implants must not be combined with implants from other manufacturers. The instruments indicated in the Surgical Technique must be used to ensure safe implantation of the components. 3. Implants must not be reused. Implants are supplied sterile and are intended for single use only. Used implants must not be reused. 4. After-treatment is also very important. The patient must be informed of the limitations of the implant. The load capacity of an implant cannot compare with that of healthy bone! 5. Unless otherwise indicated, implants are supplied in sterile packaging. Note the following conditions for storage of packaged implants: Avoid extreme or sudden changes in temperature. Sterile implants in their original, intact protective packaging may be stored in permanent buildings up until the Use by date indicated on the packaging. They must not be exposed to frost, dampness or direct sunlight, or mechanical damage. Implants may be stored in their original packaging for up to 5 years after the date of manufacture. The Use by date is indicated on the product label. Do not use an implant if the packaging is damaged. 6. Traceability is important. Please use the documentation stickers provided to ensure traceability. 7. Further information on the material composition is available on request from the manufacturer. Follow the instructions for use! Waldemar Link GmbH & Co. KG, Hamburg All content in this catalog, including text, pictures and data, is protected by law. Every instance of use, whether in part or in whole and which is not permitted by law, is subject to our prior consent. In particular, this applies to the reproduction, editing, translation, publishing, saving, processing, or passing on of content stored in databases or other electronic media and systems, in any manner or form. The information in the catalogs is solely intended to describe the products and does not constitute a guarantee. The Surgical Technique described has been written to the best of our knowledge and belief, but it does not relieve the surgeon of his/her responsibility to duly consider the particularities of each individual case. Unless otherwise indicated, all instruments are made of surgical stainless steel.

32 LINK 672_T.O.P._Impl. Instr. OP_en_ _003 Waldemar Link GmbH & Co. KG Barkhausenweg Hamburg, Germany P.O. Box Hamburg, Germany Tel.: Fax: