Surgical technique cementless and cemented

Eco ® total hip system

Eco ® total hip system cementless and cemented

Table of contents INTRODUCTION ...................................................................................................... 1

SURGICAL TECHNIQUE ......................................................................................... 3

IMPLANTS................................................................................................................ 9

INSTRUMENTS...................................................................................................... 13

IMPORTANT MEDICAL INFORMATION................................................................ 17

Nota Bene: The described surgical technique is the suggested treatment for the uncomplicated procedure.

In the final analysis the preferred treatment is that which addresses the needs of the individual patient.

Copyright note: Cepthar®, CCI®, Dia ®, Eco ®, Betha ®, LOAD ®, implavit® and implatan® are registered trademarks of implantcast GmbH. The use and copy of the content of this brochure are only

allowed with prior permit given by the implantcast GmbH.

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Introduction Lateralisation The Eco ®-total hip system includes a complete variety of cementless and cemented hip stems for the primary treatment of the hip joint. Besides the standard stem lateralised stems are available. The modular instrumentation allows the adaptation to the patients’ anatomy and enables the surgeon to customize the treatment to the patient needs. The system includes 9 sizes of cementless and 5 sizes of cemented stems. The choice of the material for each version is based on the scientific outcome of actual hip arthroplasty. Due to this the cementless stems are made of implatan® TiAl6V4-titanium alloy, the cemented stems are made of implavit® CoCrMo alloy. Economical aspects were considered when the variety, modularity and the pricing is a topic.

cementless Eco ® hip stem

with proximal coating of pure titanium (cpti)

Offsetmass EcoFit Hip in mm

size 6,25 7,5 8,75 10 11,25 12,5 13,75 15 17,5 20standard 34,5 35,2 35,8 36,5 37,1 37,7 38,3 39 40,2 41,5lateralised 42,3 43 43,6 44,3 44,9 45,5 46,1 46,8 48 49,3

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figure 1

figure 2a

Femoral neck osteotomy Due to the preoperative planning the neck of the femur is resected (fig.1). Preparation of the acetabular bone If the preparation of the acetabular bone is necessary, please consider the surgical technique provided in conjunction with the preferred implant.

Opening of the femoral canal

Please use the special awl to open the intramedullary canal (fig. 2a).

Notice: Start to use the straight awl to open the canal laterally, so the canal is prepared in the length axis of the femur. Alternatively the special box chisel can be used (fig. 2b).

figure 2b

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Broaching of the femoral canal Begin with the smallest broach to prepare the intramedullary bone. If one of the large size stem is planned please begin with a broach which is 3 to 4 sizes smaller than the implant size. Enlarge the bone preparation with the broaches of increasing sizes until you reach the size of the preoperatively chosen stem size (fig. 3a).

Notice: The broaches should be impacted until the depth marking on the handle corresponds to the rotational centre of the hip joint (regularly the marking correspond to the tip of the greater trochanter) (fig. 3b).

If the mark reaches the tip of the greater trochanter a head of the neck length medium will meet the centre of rotation.

figure 3a

figure 3b

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figure 4a

figure 4b

figure 4c

Trial reduction Remove the broach handle (fig. 4a). Attach the trial neck ‘standard’ (fig. 4b) and the trail head (28 mm or 32 mm) of the length ‘medium’ (fig. 4c). Reduce the joint and check the range of motion as well as the stability of the joint. If necessary replace the trial neck by the trial neck ‘lateralised’ or a head of a different neck length and check again the range of motion. If sufficient stabilization is achieved, remove all instruments and trial components (fig. 4d).

figure 4d

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Implantation of the Eco ®-stem

Cementless implantation

Choose the stem of the same size as the last broach. Use the stem impactor to insert the cementless Eco ®-stem (fig. 5a and 5b). Cemented implantation Please use the stem which is one size smaller than the last broach. Please consider the table below to choose the cemented stem of the appropriated size.

broach cemented stem 7,5mm 6,25mm 8,75mm 7,5mm 10mm 7,5mm 11,25mm 10mm 12,5mm 10mm 13,75mm 12,5mm 15mm 12,5mm 17,5mm 15mm Clean and dry the intramedullary canal. Insert the bone cement and impact the cemented stem by using the special impactor. The connection between the stem and the impactor allows the adjustments of the rotational alignment.

figure 5a

figure 5b

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figure 6

figure 7

Impaction of the head It is optional to perform a final stability and range of motion test (fig 6). Therefore insert a trial head of the formally used neck length.

Clean and dry the taper (12/14) and add the original head to the tester of the stem.

Use the head implants with a few strokes of a mallet to secure the taper connection (fig. 7).

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IMPLANTS Eco ® stem, cementless, standard implatan® TiAl6V4-wrought alloy acc. to DIN ISO 5832/3 with CpTi-coating acc. to DIN ISO 5832/2 HA-coating* 3039-3062 6,25 mm 3038-3062* 3039-3075 7,5 mm 3038-3075* 3039-3087 8,75 mm 3038-3087* 3039-3100 10 mm 3038-3100* 3039-3112 11,25 mm 3038-3112* 3039-3125 12,5 mm 3038-3125* 3039-3137 13,75 mm 3038-3137* 3039-3150 15 mm 3038-3150* 3039-3175 17,5 mm 3038-3175* Eco ® stem, cementless, lateralised implatan® TiAl6V4-wrought alloy acc. to DIN ISO 5832/3 with CpTi-coating acc. to DIN ISO 5832/2 HA-coating* 3039-4062 6,25 mm 3038-4062* 3039-4075 7,5 mm 3038-4075* 3039-4087 8,75 mm 3038-4087* 3039-4100 10 mm 3038-4100* 3039-4112 11,25 mm 3038-4112* 3039-4125 12,5 mm 3038-4125* 3039-4137 13,75 mm 3038-4137* 3039-4150 15 mm 3038-4150* 3039-4175 17,5 mm 3038-4175* Eco ® stem, cemented, standard implavit® CoCrMo-casting alloy acc. to DIN ISO 5832/4 polished* 3039-6062 6,25 mm 3038-0062* 3039-6075 7,5 mm 3038-0075* 3039-6100 10 mm 3038-0100* 3039-6125 12,5 mm 3038-0125* 3039-6150 15 mm 3038-0150* Eco ® stem, cemented, lateralised implavit® CoCrMo-casting alloy acc. to DIN ISO 5832/4 polished* 3039-8062 6,25 mm 3038-1062* 3039-8075 7,5 mm 3038-1075* 3039-8100 10 mm 3038-1100* 3039-8125 12,5 mm 3038-1125* 3039-8150 15 mm 3038-1150* * The marked versions are available on special request.

HA version

polished version

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IMPLANTS EcoFit® Subsider for the use in conjunction with high polished cemented EcoFit® stems 0299-0625 Subsider 6,25 mm 0299-0750 Subsider 7,5 mm 0299-1000 Subsider 10,0 mm 0299-1250 Subsider 12,5 mm 0299-0150 Subsider 15,0 mm ic-head Biolox® forte Al2O3 acc. to DIN ISO 6474 2587-2800 28 mm, K 2587-2805 28 mm, M 2587-2810 28 mm, L 2587-3200 32 mm, K 2587-3205 32 mm, M 2587-3210 32 mm, L ic-head CoCrMo implavit® CoCrMo- wrought alloy acc. to DIN ISO 5832/12 2387-2800 28 mm, K 2387-2805 28 mm, M 2387-2810 28 mm, L 2387-2815 28 mm, XL 2387-3200 32 mm, K 2387-3205 32 mm, M 2387-3210 32 mm, L 2387-3215 32 mm, XL ic-head Titan implatan® TiAl6V4 alloy acc. to DIN ISO 5832/3 with TiN-coating 2787-2800 28 mm, K 2787-2805 28 mm, M 2787-2810 28 mm, L 2787-2815 28 mm, XL 2787-3200 32 mm, K 2787-3205 32 mm, M 2787-3210 32 mm, L 2787-3215 32 mm, XL The ic-heads of titanium and CoCrMo in the lengths of XXL and XXXL are available on special request.

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IMPLANTS ic-bipolar CoCrMo implavit® CoCrMo casting alloy acc. to DIN ISO 5832/4 und UHMW-PE (DIN ISO 5834/2) 2151-0044 28/44 mm 2151-0046 28/46 mm 2151-0048 28/48 mm 2151-0050 28/50 mm 2151-0052 28/52 mm 2151-0054 28/54 mm 2151-0056 28/56 mm 2151-0058 28/58 mm 2151-0060 28/60 mm PE-Cup Müller Typ II UHMW-PE acc. to DIN ISO 5834/2 1021-2844 28/44 mm 1021-2846 28/46 mm 1021-2848 28/48 mm 1021-2850 28/50 mm 1021-2852 28/52 mm 1021-2854 28/54 mm 1021-2856 28/56 mm 1021-2858 28/58 mm 1021-3244 32/44 mm 1021-3246 32/46 mm 1021-3248 32/48 mm 1021-3250 32/50 mm 1021-3252 32/52 mm 1021-3254 32/54 mm 1021-3256 32/56 mm 1021-3258 32/58 mm The PE Cups are available with snap mechanism to enhance the protection against subluxations Intramedullary plug UHMW-PE acc. to DIN ISO 5834/2 0299-4000 small 0299-4010 large

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INSTRUMENTS Eco ® Instrument tray 7999-7040 Standard and lateralised Eco ® Instrument tray 7999-4043 Standard and lateralised easy lock Eco ® broach 7039-3062 6,25 mm 7039-3075 7,5 mm 7039-3087 8,75 mm 7039-3100 10 mm 7039-3112 11,25 mm 7039-3125 12,5 mm 7039-3137 13,75 mm 7039-3150 15 mm 7039-3175 17,5 mm Eco ® broach handle 7516-0000 Eco ® broach handle easy lock 7512-0040 Conical bar for the broach handle 7513-9999

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INSTRUMENTS ic T-handle 4223-0023 Femoral awl 7516-0005 Box chisel 7512-1099 Eco ® trial neck 7039-1214 standard 7040-1214 lateralised Trial head 28 mm & 32 mm, with taper 12/14 small 7960-2823 medium 7960-2825 large 7960-2827 extra large 7960-2828 small 7960-3223 medium 7960-3225 large 7960-3227 extra large 7960-3228 Head impactor 7512-4444 Stem impactor 3039-0101

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INSTRUMENTS ic- bipolar tray 7960-9999 Handle for bipolar sizing tray 7960-6000 Bipolar sizing head 7960-0044 28/44 mm 7960-0046 28/46 mm 7960-0048 28/48 mm 7960-0050 28/50 mm 7960-0052 28/52 mm 7960-0054 28/54 mm 7960-0056 28/56 mm 7960-0058 28/58 mm 7960-0060 28/60 mm ic-forceps for bipolar head 7960-6010

IMPORTANT MEDICAL INFORMATION

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1. Packing unity/product name This information concerns: hip prosthesis according to ISO 5832/1, /3, /4, /11 or /12 femoral heads according to ISO 5832/1, /3, /4, /9 or /12 acetabular cups according to ISO 5832/3 or 4 acetabular cups and inlays according to ISO 5834/2 bipolar heads according to ISO 5832/1 or /3 with ISO 5832/4 acetabularcups or liners according to ISO 5834/2 Biolox® forte liners according to ISO 6474 Biolox® forte femoral heads according to ISO 6474 reconstruction acetabular implants acc. to ISO 5832/1 Cement restrictors acc. to ISO 5834/2 or gelatine Bone screws according to ISO 5832/3 or /1 Golden femoral heads are coated with a ceramic TiN-coating A few of the cemented hip prostheses are combined with centralisers of PMMA. The x-ray implants are titanium alloy according to ISO 5832/3 or 5832/1. Product name, size, article number and lot number are indicated on the product label and the enclosed interior labels. We recommend to put the interior labels onto the patient file or the surgical report.

2. Introductory remarks This prosthesis must only be implanted by persons whose skills can – due to their training, know-how and practical experience – guarantee for a proper use of the system. This user information can only provide some of the basic information necessary for the use of the product. Further information is available from the manufacturer. Prior to surgery the surgeon must work out a surgical plan comprising the dimensions of the prosthesis and the positioning of the implant components in the patient’s bone. It must be assured that: • all necessary implant components are present • the corresponding instrument set is complete

Never reused implants which have already been implanted or removed, even if it appears undamaged, former stress could have lead to conditions which might cause a mechanical defect. The use of a new prosthesis of the respectively latest type is recommended.

3. Packaging and sterility All implant components are packaged separately in sealed triple-peel pouches or double blister packaging. Metal components have been sterilized by gamma radiation (min. 25 kGy). All polyethylene components have been sterilised by EtO-Gas or by gamma radiation (min. 25 kGy). The individual sterlisation method is indicated on the product labelling. The red point on the second protective cover indicates the performed radiation sterilisation and the green point for EtO sterilisation. The outer cover is for protection only. Please always take note of the expiry date, indicated behind the symbol . . After expiry of this date the product must not be implanted any more.

4. Resterilisation

The manufacturer only guarantees for implants which have been implanted directly after removal of the original packaging. We do not accept any reliabilities for resterilised products.

The following recommendations are only provided for your information: Implants must not be resterilised

• if they consist of Polyethylene or DLPLA or gelatine, partly or

entirely, • if they are coated, partly or entirely, • if they have any kind of defect, no matter of what kind or size, • if they have been implanted before. Resterilisation is to be performed by autoclave. Sterilization quality must be secured by appropriate test procedures. Original packaging must not be reused and must be replaced by appropriate autoclave packaging. Implants must never be sterilized assembled (e.g. head and shaft). This can lead to (possibly invisible) component defects. All coated and polished surfaces are to be protected during resterilisation. Standard cleaning methods offer no guarantee for the removal of pollution from porous surfaces. The correct setting of the autoclave must be checked regularly.

5. Operation and storage The implant should always be kept in its original packaging, in an adequate storing room for sterile products. Before use of the implant the packaging must be checked for damages. The product remains sterile as long as the packaging has not been opened or damaged and before passing the expiry date. When removing the implant from the packaging please make sure that the actual implant corresponds to the information given on the label on the cover (concerning lot-no. and size). Please follow the appropriate aseptic instructions when removing the packaging from the implant. The implant surface is extremely sensitive. The implants must not get in touch with objects which may damage their surface. Manipulation or bending of an implant can not only shorten its lifetime, under stress it can also cause an implant failure, immediately or after a certain period of time. Any manipulation of the implant affects its performance and must therefore be avoided. Before implantation the implant must be checked visually for possible defects. Damaged implants must not be used. The use of bone cement is subject to the operational instructions of the respective manufacturer. Bone cement must not get in touch with or remain on the sensitive articular surface, neither intraoperatively nor postoperatively. All extruded cement must be carefully removed to make sure no remains can migrate to the articular surface. This could lead to increased wear or to severe damage and failure of single implant components. For cementless insertion a solid fixation during the surgical procedure is of major importance for the success of the operation. The fixation of the femoral shaft within the prepared femur must be performed under pressure (press fit). This requires a precise handling and the use of special instruments. A reliable fit of the cone interfaces can only be achieved if the surfaces of the femoral head and the cone of the respective prosthesis are completely intact. Both cones must in any case correspond in size. Ceramic heads must only be attached to brand new cones. The cone of the respective prosthesis must be cleaned and dried before being attached. For an intraoperative femoral head exchange a metal head must be selected, provided that the cone of the prosthesis shows no signs of damage. Should a cone damaged, the prosthesis must be replaced.

IMPORTANT MEDICAL INFORMATION

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6. Compatibility The latest manufacturing and testing procedures guarantee for a compatibility of any ic-implant with another ic-implant of corresponding size (diameter, cone-dimensions, inlay-size etc.), regardless their manufacturing date. The correspondence of the exterior diameter of the acetabular and femoral head components (28 and 32 mm), as well as of the cones of head and shaft (cone 12/14) must always be carefully checked. For one and the same acetabular type there are often several inlay-types available (different interior diameters). The ic-acetabular inlays must only be combined with ic-metal components of the same type. All ic hip stems or acetabulum shells are certified for the use of Biolox® forte ceramic heads or liners. Moreover, due to standardization on the endoprosthesis market, the ic-implants are compatible to and can replace those of other manufacturers and distributors. On request, the manufacturer can give information on the compatibility to a certain product. If there is any doubt, the diameter of the articular surfaces and the fit of the femoral heads (exterior diameter) and acetabuli (interior diameter) should be checked or made sure with the respective instruments before the actual insertion.

7. Indications Prior to the decision to implant an arthroplasty the results of all examinations must be considered thoroughly. An arthroplasty is only indicated if the prospective success of all other conservative and surgical therapeutical alternatives is considerably lower than that of an arthroplasty. Careful preoperative planning and a precise surgical technique are necessary to obtain optimal results. In order to minimize the danger of postoperative complications different factors must be considered, i.e. the anatomical stress situation, the soft tissue basis and the features of the bony implant bearing. On the basis of the a.m. principles indications for an arthroplasty are: • severe articular destruction with considerably restricted

mobility, if other therapeutical steps are not promising. • a prospective long-life result of the planned implantation also

with respect to the patient’s weight, age and physical activity. • severe arthropathy due to degenerative and rheumatoid

arthritis, articular fractures or osteonecrosis. • postoperative conditions requiring revision surgery after

operations with or without implantation of an arthroplasty.

8. Contraindications The lifetime of an endoprosthesis can be limited because of biological, material-specific and biomechanical factors. Therefore the indication of an arthroplasty must be carefully considered for obese patients, in cases of extraordinary stress on the articulation due to excessive physical activity and for any patient below 60 years of age. Moreover, special attention must be directed to patients with allergies to one or several component materials and to patients suffering from mental illness or neurosis, which may affect their ability to follow the restrictions in activity. Further, the success of the operation can be affected by • acute or chronical infections • extensive bone defects or inadequate bone quality, making the

implantation or a solid primary fixation of the implant impossible • neurogenous arthropathy • severe myopathy, neuropathy or angiopathy of the respective

extremity • prospective overload or excessive forces on the implant • excessive physical activity or strain • accidental falling or other joint resultant forces

• severe osteoporosis • bone tumors in the implant fixation area • severe deformity or defective axial position • metabolic disorders/allergies • drug addiction and abuse (alcohol!) The patient must be informed about the implant’s stress limitations and the possible consequences resulting from the a.m. conditions with regard to the surgical success. Stress bearing of an implant can never be the same as for a healthy physiological bone structure. The patient must be warned of the consequences of excessive stress on the implant especially before the end of the postoperative healing process. All information given to the patient should be documented in writing by the surgeon.

9. Complications The complications and negative consequences listed below are some of the most typical and most common adverse effects of hip surgeries: • device component loosening, distortion or fracture. These

effects rarely occur and are normally caused by one or several of the mentioned loosening factors, listed above or below,

• under contraindications and warnings, • acute postoperative wound infection and delayed infection,

possibly leading to sepsis, • migration or subluxation of the implant resulting in reduced

mobility, • increased or decreased leg length or bone wear, • bone fractures due to unilateral stress bearing, • cardiovascular disorders, e.g. thrombosis and embolism, • wound haematoma and delayed healing process, • temporary or persistent neurological disorders, • tissue reaction due to allergies or foreign body-reactions

caused by frictional particles, • myositis ossificans. Please give us notice in the case of any complications related to the use of our implants and instruments. Manufacturer and distributor of the system cannot accept any reliability for any complications or negative effects arising from mistakes in indication, from improper surgical techniques, inadequate material selection or handling or from asepsis. All these effects are subject to the surgeons’s responsibility.

implantcast GmbH Lüneburger Schanze 26 D-21614 Buxtehude, Germany phone : +49 4161 744 0 fax : +49 4161 744 200 e-mail: info@implantcast.de internet :www.implantcast.de

0123 Technical modifications are subject to change without notice. All implants have been developed, manufactured and tested according to latest technical standards. No part of this document may be duplicated without prior consent of implantcast GmbH.

Your local distributor:

implantcast GmbH Lüneburger Schanze 26

D-21614 Buxtehude Germany

phone: +49 4161 744-0 fax: +49 4161 744-200

e-mail: info@implantcast.de internet: www.implantcast.de E

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