Cementless femoral stem type SF

Transcription

1 Cementless femoral stem type SF Cementless Femoral Hip Joint Components ARTHROPLASTY

2 Implant Description Surgical Technique Instrumentation Set Catalogue Preface The cementless stem of a total hip joint replacement type SF of the 2nd generation was designed using the latest knowledge and experience with cementless endoprostheses. It is made of titanium alloy and the most modern technology of surfacing with CNC-controlled machines is used during its manufacturing. The surface is conditioned with plasma coating of bioactive titanium oxide layer that ensures full biocompatibility of the implant. The instruments ensure easy implantation and thorough fixation. A wide size series available makes it possible to solve almost every case of first implantation. IN GENERAL The cementless stem type SF of the 2nd generation is used in the first implantation of total hip joint replacement and is intended for biologically younger patients with good vitality and probability of good integration of the implant with the bone tissue. The complete set of cementless total hip joint replacement consists of a femoral component (stem), a head and an acetabular component (cup). The set can be combined without limitation within the whole supplied size series. A head with 12/14 taper can be fixed on the stem. The diameter of the head is determined by the corresponding inside diameter of the articulation insert. Characteristics of the implant: MASSIVE STEM Guarantees the possibility of repeated high strain without fatigue breaks. PERFECTLY ADJUSTED MEDULLARY CANAL Excellent primary fixation. BIOACTIVE SURFACE COATING Verified fast secondary fixation by osteointegration. CYLINDRICAL DISTAL TAIL-PIECE Optimal adjustment of shape of the medullary cavity. COLLARFREE OPTION Easy implantation and perfect fitting without the necessity of osteotomy line adjustment. 2

3 Cementless total hip joint replacement type SF of the 2nd generation Solution for biologically younger patients ARTICULATION SURFACES: CERAMICS CROSSLINKED UHMWPE Reduction of abrasive wear and osteolysis limitation. NEW PE-LINER WITH TWELWE-EDGED PROFILE Easy insertion of the liner into the covering in its whole circumference. SHORTER STEM, TAPERED IN THE PROXIMAL PART Can be used also in MIS surgeries. ACETABULAR CUP WITH FIXATION SCREWS Possibility of rotation-proof fixation. OPTIMAL SET AS TO ITS PRICE/PERFORMANCE RATIO 3

4 Implant Description Surgical Technique Instrumentation Set Catalogue Examples of supplied templates for comparison with X-ray pictures HEAD Ø 28 TROCHANTER STANDARD STEM TAPERED STEM TOTAL HIP JOINT REPLACEMENT STEM S.F. Ø 11 SIZE 2 MAGNIFIED BY 20% FOR COMPARISON WITH X-RAY PICTURE SCALE: 1,20 : 1 4

5 HEAD Ø 28 TROCHANTER STANDARD STEM TAPERED STEM TOTAL HIP JOINT REPLACEMENT STEM S.F. Ø 17 SIZE 8 MAGNIFIED BY 20% FOR COMPARISON WITH X-RAY PICTURE SCALE: 1,20 : 1 5

6 Implant Description Surgical Technique Instrumentation Set Catalogue Surgical technique general principles 6 Before any surgery of total hip joint replacement, it is necessary to make a presurgery planning that will enable us to determine the correct size of both the acetabular and the femoral components. Moreover, due to the fact that femoral components are available in standard or tapered modifications, we must know the mediolateral width of the metaphysis in order to select the appropriate type. An X-ray picture of the pelvis and of both hip joints in two projections must be available for the pre-surgery planning in order to determine the metaphysis width. Templates supplied by the manufacturer are used for planning of size of both components. To determine the size of the components, these templates are placed over X-ray pictures with the same magnification. The correct size of the femoral component is determined when the stem on the template fills completely the medullary canal on the X-ray picture and, in the isthmus area, has a good contact with the endosteal bone in the extension of 1-2 cm. The choice between standard or tapered types is made following the same procedure on the dorsoanterior picture of the hip, again trying to achieve an optimal contact with endosteal edges of the metaphysis. The surgery of the total hip joint replacement may be carried out using any approach according to the surgeon s habitual practice. At the usual antero-lateral approach, first resect the head with the neck and then proceed to surfacing and prosthetic replacement of the acetabular cup. Adjustment of the femur medullary canal and insertion of the femoral component is thus carried out only after the acetabular phase is completed. On the contrary, at the postero-lateral approach, we first dislocate the head backwards and then we open the medullary cavity in fossa piriformis using a perforator, without resecting the head. Subsequently, the medullary canal is shaped to the selected size and only then the osteotomy at the neck basis is carried out and the head is removed. We therefore perform the adjustment and replacement of the acetabular cup only after the preparation of the femur medullary canal. After the acetabular component is inserted, we finally implant the stem into the prepared medullary canal of the femur. The primary fixation of both components achieved during the surgery is reinforced as the bone tissue grows into the porous titanium surface coating, the so-called secondary fixation. This is achieved progressively in weeks following the implantation of the replacement. After this period, the implant is usually firmly connected with the surrounding bone. A perfect primary fixation of the stem is ensured as the diameter of the stem is 0,5 mm larger than the milled medullary canal. A table of correct relations between the instruments used for surfacing of the femur medullary canal and the inserted implants is given here for clarity: Diameter of milling cutters [mm] STEM Diameter of femoral stem [mm] 10,5/10 11,5/11 12,5/12 13,5/13 14,5/14 15,5/15 16,5/16 17,5/17 18,5/18

7 Surgical Technique 1. Perforation of corticalis Perforator 1 shall be used only at posterior approach when the patient is positioned on his/her side (Fig. 1). At antero-lateral approach, this instrument is not used after the resection of the head. When using the perforator, the hole must be located in fossa piriformis. 1 Fig Resection of the head The head is resected using an oscillatory saw (Fig. 2). In case of a posterior approach, the head is resected only after the use of the perforator (1) 1 and of the milling cutters (3) 3 to 12 with cylindrical stem according to point 3. The perforator and the cutters can be fixed into the T handle 2. Fig. 2 Numbers marked ( ) correspond to the cassette lay-out (see page 12). 7

8 Implant Description Surgical Technique Instrumentation Set Catalogue 3. Widening of entrance to the metaphysis part of the canal A window-chisel 16 is used to widen the metaphysis part of the medullary canal under the osteotomy line (Fig. 3). The point of the chisel must run along the interior lateral surface of the cortical bone. The orientation of the chisel must keep the planned anteversion of the femoral component (10 to 15 ). 16 Fig Milling of the medullary canal Special milling cutters 3 to 12 with cylindrical stem are used to mill the medullary canal (Fig. 4). First, milling cutters of 8mm in diameter are used, followed by 10mm cutters corresponding to the stem size 10. The following cutters are graded by 1mm up to 18mm in diameter. Milling is done gradually up to the diameter corresponding to the selected implant. A strip on the cutters indicates the milling depth. We recommend to follow the use of the 12mm milling cutters by an adjustment of the upper part of the medullary canal using a rasp of the same size (see next point of the surgery procedure). Ø8 strip 3 Ø10 18 strip 4 12 Fig. 4 8

9 5. Preparation of the medullary canal The final preparation of the medullary canal is carried out using a set of rasps 17 to 34 (Fig. 5), with shape corresponding to the metaphysis profile of the femur and size 0.5 mm smaller than the size of the implant. Rasps are available in tapered option (designated ML) and broader option (designated S). They are used depending on the anatomical condition of the upper end of the femur, i.e. on the mediolateral size of the metaphysis. The diameter of the largest rasp is determined by the size of the milled medullary canal. The depth of the rasp insertion is determined when the rasp ratchet part enters fully into the osteotomy line. We recommend to follow the use of the 12 mm milling cutters (6) 6 by an adjustment of the upper part of the medullary canal using a rasp of the same size. The same procedure is observed after the use of other milling cutters, i.e. 13mm 7, 14mm 8 etc., in order to avoid excessive milling of the medullary canal under the metaphysis in the isthmus area, where it would be possible to insert the cylindrical part of the stem, but the upper part of the stem with the sprayed coating surface would exceed the size of the metaphysis if its diameter were too narrow and its perfect insertion so that upper skew edge of plasma spray coating attains to the same level with an osteotomy line. To remove the rasp from the medullary canal it is necessary to fix the handle 35 with the extractor pin 45 again on the rasp (Fig. 5) Fig Milling of the fitting surface Possible adjustment of the surface after osteotomy can be made using disk cutters 13 fixed in a driller, or possibly by hand cutting with the cutters fixed into the T -handle 2. Fig. 6 9

10 Implant Description Surgical Technique Instrumentation Set Catalogue 7. Preliminary test of articulation (on the rasp) Preliminary articulation is carried out using a plastic testing head 37 to 40 fixed on the cylindrical neck of the rasp (Fig. 7). Testing heads are available in four options differing by the neck length S, M, L, XL. These heads are intended for test of articulation into testing inserts of cementless cup covering. To remove the rasp from the medullary canal we use the handle 35 with the extractor pin 45 (see Fig. 5) Fig Insertion of femoral component The cementless endoprosthesis is inserted into the femur using the stopper 14, inserted into the hole of 4 mm in diameter in the stem axis. The component is inserted first by hand and then with the stopper until firm fitting on the femoral calcar is achieved (Fig. 8). If necessary, the inserter 36 fixed in a hole in the proximal part of the stem can be used to position the endoprosthesis during its insertion Fig. 8

11 9. Final test of articulation (of the femoral component) The final test of articulation is carried out using a test or a polyethylene articulation liner. One of the four testing plastic heads 41 to 44 is used for this test of articulation (Fig. 9) and an appropriate metal or ceramic head is selected on the basis of this test. 10. Articulation of the endoprosthesis Final articulation is carried out using the head inserting instrument 15 (Fig. 10). 15 XL L M S Fig. 9 Fig Final result of the surgery Position when the head has been articulated into the acetabular cup (Fig. 11). Fig.11 11

12 Implant Description Surgical Technique Instrumentation Set Catalogue Instrumentation set The set of instruments is placed in two cassettes allowing a clear lay-out of the instruments not only during transportation, storage and preparation, but also during the surgery. The lay-out of the instruments in the sieve cassette corresponds to pictures in the surgical technique manual. During transportation, the cassettes are placed in a container allowing sterilization INSTRUMENTS FOR APPLICATION OF CEMENTLESS STEM TYPE SF LAY-OUT CASSETTE I Denomination Qty Order number Cassette with lay-out of instruments I Perforator for femoral stem T-handle with triangular head Milling cutters (CSC) cylindrical ø 8 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 10 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 11 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 12 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 13 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 14 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 15 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 16 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 17 mm triangular end (Synthes) Milling cutters (CSC) cylindrical ø 18 mm triangular end (Synthes) Disc cutters Stopper for femoral stem type SF Head inserting instrument Note: The cassette lay-out has only an informative character and may be amended depending on inovation changes carried out. 12

13 INSTRUMENTS FOR APPLICATION OF CEMENTLESS STEM TYPE SF LAY-OUT CASSETTE II Denomination Qty Order number Cassette with lay-out of instruments II Window-chisel for femoral stem Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/S, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp for cementless femoral stem type SF/ML, size Rasp handle 2 pcs Femoral stem inserter Trial head 28 for rasp femoral stem type SF and Poldi, size S Trial head 28 for rasp femoral stem type SF and Poldi, size M Trial head 28 for rasp femoral stem type SF and Poldi, size L Trial head 28 for rasp femoral stem type SF and Poldi, size XL Trial head diameter 28mm, cylindrical 12/14 for femoral stem, size S Trial head diameter 28mm, cylindrical 12/14 for femoral stem, size M Trial head diameter 28mm, cylindrical 12/14 for femoral stem, size L Trial head diameter 28mm, cylindrical 12/14 for femoral stem, size XL Extractor pin

14 Implant Description Surgical Technique Instrumentation Set Catalogue Implants The stem of a total hip joint replacement destined for implantation without bone cement is made of titanium alloy Ti6AI4V. It is supplied in two modifications: S standard one and ML mediolateral tapered one. The ML option is destined for a thigh bone with metaphysis narrow in mediolateral diameter, as shown by X-ray picture in dorso-anterior projection. Each stem is available in 9 sizes with diameter from 10 to 18 mm, graded by 1 mm. The upper part of the stem is covered by a plasma porous coated titanium layer. The stems are manufactured without collar. The neck is ended by a 12/14 taper (EURO). The CD angle of the endoprosthesis is 135 degrees. Stem type SF Taper 12/ S standard Size ØD / ØD 1 Order [mm] number 10/S 10,5 / /S 11,5 / /S 12,5 / /S 13,5 / /S 14,5 / /S 15,5 / /S 16,5 / /S 17,5 / /S 18,5 / Ø D Ø D 1 Size ML mediolateral ØD / ØD 1 [mm] 10/ML 10,5 / 10 11/ML 11,5 / 11 12/ML 12,5 / 12 13/ML 13,5 / 13 14/ML 14,5 / 14 15/ML 15,5 / 15 16/ML 16,5 / 16 17/ML 17,5 / 17 18/ML 18,5 / 18 Order number

15 Combination of SF stem with other implants manufactured by BEZNOSKA company Cementless acetabular cup type SF Cemented acetabular cup type 02 Stem type SF Cemented acetabular cup type Poldi Metal head Reconstruction acetabular cage type BS Cobalt head Oval acetabular cup type TC Ceramic head Revision acetabular cup type RSC 15

16 THE EUROPEAN REGIONAL DEVELOPMENT FUND AND THE MINISTRY OF INDUSTRY AND TRADE OF THE CZECH REPUBLIC SUPPORT INVESTMENT IN YOUR FUTURE. Dělnická 2727, Kladno, Czech Republic tel.: , GSM: fax: ,