original m.e. muller low profile cup surgical technique ... · 2 original m.e. müller® low...
TRANSCRIPT
Original M.E. Müller®
Low Profile Cup
Surgical Technique
Evolution of a Proven Concept
Original M.E. Müller® Low Profile Cup2
DisclaimerThis document is intended exclusively for physicians and is not intended for laypersons.
Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part.
Information contained in this document was gathered and compiled by medical experts and qualified Zimmer personnel. The information contained herein is accurate to the best knowledge of Zimmer and of those experts and personnel involved in its compilation. However, Zimmer does not assume any liability for the accuracy, completeness or quality of the information in this document, and Zimmer is not liable for any losses, tangible or intangible, that may be caused by the use of this information.
Original M.E. Müller® Low Profile Cup 3
Surgical Technique Original M.E. MüllerLow Profile Cup
Table of Content
Original M.E. Müller Low Profile Cup 4
Indications 5
Contraindications 5
Preoperative Planning 6
Surgical Technique 7
Surgical Approach 7
Exposure of the Acetabulum 7
Reaming the Acetabulum 7
Drilling Holes into the Acetabulum 8
Cleaning the Acetabulum 8
Insertion of the Bone Cement 8
Precompression of the Cement 9
Insertion and Orientation of the Cup 9
Implants 10
Combination with Rings and Cages 12
Instruments 14
Hi-Fatigue™ Bone Cement 15
Original M.E. Müller® Low Profile Cup4
Original M.E. Müller Low Profile Cup
With more than 875,000 implantations worldwide, and over 25 years of clinical use, the Original M. E. Müller® (M.E.M.) Low Profile Cup is a widely applied und trusted solution for replacement of the ace tabu lum. The cup is designed with a macrostructured surface to ensure optimal fixation in the cement mantle. The Original M.E. Müller Low Profile Cup shows excellent clinical results* and convinces surgeons by its ease of use.
* List of publications is shown in the Original M.E. Müller Low Profile Cup brochure Lit. No. 06.01601.012.
Original M.E. Müller® Low Profile Cup 5
Indications
The Original M.E. Müller Low Profile Cup is applicable for various indica-tions, ranging from simple primary cases to complex cases in revision. For best clinical results, the implant must be embedded in a stable acetabular structure. In cases of poor bone quality or deficient bone stock, the Original M.E. Müller Low Profile Cup can be combined with cages or rings to ensure optimal fixation. The system offers a cost-effective and simple solution for:
• Primary hip replacement if the bone quality is adequate and there is sufficient bone coverage
• Primary hip replacement when com-bined with an ARR-Ring (Aceta bular Roof Reinforcement Ring), e.g. for DDH cases (Developmental Dysplasia of the Hip)
• For revision cases with the use of a ring or a cage
Contraindications
The use of the Original M.E. Müller Low Profile Cup alone should not be considered in presence of poor bone quality where the use of a ring or cage is indicated.*
* For correct use of rings and cages, please refer to the respective surgical technique brochure.
Original M.E. Müller® Low Profile Cup6
Preoperative Planning
Preoperative planning is key to a good surgical outcome. Planning allows to anticipate potential surgical compli-cations while determining size and position of the implant intended to be used. In cases of acetabular dysplasia, planning is essential in deciding whether to consider the aid of grafts, rings, or cages.*
The basis for the preoperative planning is provided by X-ray images and product-specific templates. To find the correct center of rotation, and thus to ensure correct leg length, the anatomy of the healthy pelvis is first mirrored to the affected side. The template is then placed onto the patient’s radiograph to determine the correct size and position of the acetabular component. The cup should be placed at an inclination of approximately 35°–40° with reference to the pelvic line, and at approximately 15° ± 5° of anteversion. It should be noted that correct placement of the cup may also depend on positioning of the femoral component. The antetorsion of the femoral component should be in the range of 10°–15°.
Original M.E. Müller™ Low Profile Cup, Cemented
This reference number must correspond to that
of the prosthesis to be implanted. © All rights reserved,
Zimmer GmbH, CH-8404 Winterthur, Switzerland
Lit. No. 06.00807.000x – Ed. 9/2007 WL
+H8440600807000X1/$070901I07Z
15 cm
20 cm
10 cm
5 cm
10 cm 15 cm5 cm
Magnification 1.15:1
Size 38REF-Number of the Product:63.22.38 ∅ 22 Sulene-PE
Size 36REF-Number of the Product:63.22.36 ∅ 22 Sulene-PE
Size 40REF-Number of the Product:63.22.40 ∅ 22 Sulene-PE
Size 42REF-Number of the Product:63.22.42 ∅ 22 Sulene-PE63.28.42 ∅ 28 Sulene-PE01.00284.042 ∅ 28 Durasul
* For correct use of rings and cages, please refer to the respective surgical technique brochure.
Original M.E. Müller® Low Profile Cup 7
Surgical Technique
Surgical Approach The Original M.E. Müller Low Profile Cup can be implanted using a variety of surgical approaches. The specific ap-proach depends on the surgeon’s pref-erence and therefore may differ from the procedure shown below. Exposure of the AcetabulumA clean exposure of the acetabulum is necessary to successfully implant the cup. Fibrous, cartilaginous bone structures and osteophytes must be removed from the area, as they prevent the preparation of the acetabulum.
Reaming the AcetabulumA hemispherical acetabular cavity is prepared using hemispherical reamers. Bear in mind that the sizes of reamers don’t include the cement mantle thick-ness, i.e. for the use of a 52 mm cup, a reamer with size 54 mm is required.
Starting with the smallest reamer the acetabulum is reamed in medial direc-tion until the preplanned center of rotation is achieved (Fig. 1).
Warning: Depending on the type of reamer used, the design of cutting holes and thus the cutting behaviour can differ.
Surgeons must then adapt the orien-teation of the reamer. Then, the reamer with the size of the preselected cup is chosen to attain the zone of vascular bleeding and to form the cavity (Fig. 2).
Fig. 1
Fig. 2
Original M.E. Müller® Low Profile Cup8
Drilling Holes into the AcetabulumDepending on the size of the acetabu-lum, a number of anchorage holes are drilled along the rim of the acetabulum (Fig. 3). These holes should be around 5 mm in diameter and have a depth of around 0,5–1 cm.
Cleaning the AcetabulumBone debris from reaming and drilling is washed out. Gauze is pressed firmly into the acetabular cavity to minimize bleeding.
Insertion of the Bone CementThe gauze is removed from the ace-tabulum and the required amount of cement is packed into the area. With the use of injection or the finger-pack-ing method, cement is first placed into the anchorage holes, followed by the acetabular area (Fig. 4).
Please refer to the product usage bro-chures of the specific bone cement for more details on their usage (Lit. No. 97-1120-001-00).
Fig. 3
Fig. 4
Original M.E. Müller® Low Profile Cup 9
Precompression of the CementSurgical techniques for use of cement can vary by product; please refer to the respective cement for more details.
Insertion and Orientation Of the Cup The predetermined cup is positioned by hand on the semiviscous cement bed. It has to be pushed in first hori-zontally and then as far in a medial direction as possible (Fig. 5).
Excess cement is removed with the narrow curette (Fig. 6). With the help of a cup-positioning instrument with ring, the cup is then aligned at an angle of 35°–40° and with an anteversion of 10°–15° (Fig. 7). Continuous pres-sure is used to move the cup until it is seated evenly into the reamed ace-tabulum. The positioning top is then removed to avoid further changes of cup positioning.
The top for the impactor without rim is then used to apply pressure to the area, and excess cement is trimmed from the acetabulum (Fig. 6). Continu-ous pressure should be applied to the cup until cement polymerization is complete. A trial reduction is then performed with the implanted stem and trial heads.
Fig. 5
Fig. 6
Fig. 7
Original M.E. Müller® Low Profile Cup10
Implants
M.E. Müller® Low Profile Cup, cemented
Details
UHMW Polyethylene (Sulene® PE) Radiological mark CP Titanium (Protasul® Ti)
Size [mm] REF
361 63.22.36381 63.22.38401 63.22.4042 63.22.4244 63.22.4446 63.22.4648 63.22.4850 63.22.5052 63.22.5254 63.22.5456 63.22.5658 63.22.58– –– –– –
22 mm
Details
UHMW Polyethylene (Sulene® PE) Radiological mark CP Titanium (Protasul® Ti)
Size [mm] REF
– –– –– –421 63.28.4244 63.28.4446 63.28.4648 63.28.4850 63.28.5052 63.28.5254 63.28.5456 63.28.5658 63.28.5860 63.28.6062 63.28.6264 63.28.64
Details
UHMW Polyethylene (Sulene® PE) Radiological mark CP Titanium (Protasul® Ti)
Size [mm] REF
– –– –– –– –441 63.32.44461 63.32.4648 63.32.4850 63.32.5052 63.32.5254 63.32.5456 63.32.5658 63.32.5860 63.32.6062 63.32.6264 63.32.64
28 mm 32 mm
1 Must be used in combination with cages and rings.
Original M.E. Müller® Low Profile Cup 11
Details
Durasul®
Radiological mark CP Titanium (Protasul® Ti)
Size [mm] REF
– –– –– –48 05.95001.05050 05.95001.05152 05.95001.05254 05.95001.05356 05.95001.05458 05.95001.05560 05.95001.05662 05.95001.05764 05.95001.058
M.E.Müller® Low Profile Cup, cemented
Details
Durasul® Radiological mark CP Titanium (Protasul® Ti)
Size [mm] REF
42 01.00284.04244 01.00284.04446 01.00284.04648 01.00284.04850 01.00284.05052 01.00284.05254 01.00284.05456 01.00284.05658 01.00284.05860 01.00284.06062 01.00284.06264 01.00284.064
28 mm
Details
Durasul®
Radiological mark CP Titanium (Protasul® Ti)
Size [mm] REF
– –44 01.00324.04446 01.00324.04648 01.00324.04850 01.00324.05052 01.00324.05254 01.00324.05456 01.00324.05658 01.00324.05860 01.00324.06062 01.00324.06264 01.00324.064
32 mm 36 mm
EO EO EO
Original M.E. Müller® Low Profile Cup12
1 With a 2 mm cement layer2 With a 1 mm cement layer
Ref.Number Ring OuterDiameter (mm)
PE CupDiameter(mm)
Sulene PE22 mm
Sulene PE28 mm
Sulene PE32 mm
Durasul28 mm
Durasul32 mm
Durasul36 mm
36 97.36.49 42 362 63.22.36 – – – – –
38 97.38.49 44 361
382
63.22.3663.22.38
––
––
––
––
––
40 97.40.49 46 381
402
63.22.3863.22.40
––
––
––
––
––
42 97.42.49 48 401
422
63.22.4063.22.42
–63.28.42
––
–01.00284.042
––
––
44 97.44.49 50 421
442
63.22.4263.22.44
63.28.4263.28.44
–63.32.44
01.00284.04201.00284.044
–01.00324.044
––
46 97.46.49 52 441
462
63.22.4463.22.46
63.28.4463.28.46
63.32.4463.32.46
01.00284.04401.00284.046
01.00324.04401.00324.046
––
48 97.48.49 54 461
482
63.22.4663.22.48
63.28.4663.28.48
63.32.4663.32.48
01.00284.04601.00284.048
01.00324.04601.00324.048
–05.95001.050
50 97.50.49 56 481
502
63.22.4863.22.50
63.28.4863.28.50
63.32.4863.32.50
01.00284.04801.00284.050
01.00324.04801.00324.050
05.95001.05005.95001.051
52 97.52.49 58 501
522
63.22.5063.22.52
63.28.5063.28.52
63.32.5063.32.52
01.00284.05001.00284.052
01.00324.05001.00324.052
05.95001.05105.95001.052
54 97.54.49 60 521
542
63.22.5263.22.54
63.28.5263.28.54
63.32.5263.32.54
01.00284.05201.00284.054
01.00324.05201.00324.054
05.95001.05205.95001.053
56 97.56.49 62 541
562
63.22.5463.22.56
63.28.5463.28.56
63.32.5463.32.56
01.00284.05401.00284.056
01.00324.05401.00324.056
05.95001.05305.95001.054
58 97.58.49 64 561
582
63.22.5663.22.58
63.28.5663.28.58
63.32.5663.32.58
01.00284.05601.00284.058
01.00324.05601.00324.058
05.95001.05405.95001.055
Original M.E. Müller Low Profile CupsOriginal M.E. Müller Ring
Principle
Combination with Rings and Cages
Choice of Original M.E. Müller Low Profile Cup size• Biggest size applicable must corres-
pond to the nominal number of the respective ring or cage (i.e. cup dia-meter of maximum 50 mm is allowed to use with a cage or ring size 50)
• Otherwise use 1–2 sizes smaller than the nominal number indicated on the ring or cage
Choice of reamer• Always use final reamer size of
+4 mm with respect to the final cup diameter
• This will result in a true diameter of +6 mm to consider the application of a 2 mm cement mantle
Original M.E. Müller® Low Profile Cup 13
Ref. Number Cage Outer Diameter (mm)
Cage Inner Diameter (mm)
PE Cup Diameter (mm)
Sulene22 mm
Sulene28 mm
Sulene32 mm
Durasul28 mm
Durasul32 mm
Durasul36 mm
40 01.00191.1401
01.00191.2402
46 42 383
404
63.22.3863.22.40
––
––
––
––
––
44 01.00191.1441
01.00191.2442
50 46 423
444
63.22.4263.22.44
63.28.4263.28.44
–63.32.44
01.00284.04201.00284.044
–01.00324.044
––
50 01.00191.1501
01.00191.2502
56 52 483
504
63.22.4863.22.50
63.28.4863.28.50
63.32.4863.32.50
01.00284.04801.00284.050
01.00324.04801.00324.050
05.95001.05005.95001.051
56 01.00191.1561
01.00191.2562
62 58 543
564
63.22.5463.22.56
63.28.5463.28.56
63.32.5463.32.56
01.00284.05401.00284.056
01.00324.05401.00324.056
05.95001.05305.95001.054
62 01.00191.1621
01.00191.2622
68 64 603
624
––
63.28.6063.28.62
63.32.6063.32.62
01.00284.06001.00284.062
01.00324.06001.00324.062
05.95001.05605.95001.057
1 Left cage2 Right cage
The size of the inlay should be chosen to be either the same size as the shell or smaller.
The thickness of the cement mantle varies accordingly.3 With a 2 mm cement mantle4 With a 1 mm cement mantle
Burch-Schneider™ Reinforcement Cage Original M.E. Müller Low Profile Cups
Ref. Number Ring Outer Diameter (mm)
PE Cup Diameter (mm)
Sulene PE22 mm
Sulene PE28 mm
Sulene PE32 mm
Durasul28 mm
Durasul32 mm
Durasul36 mm
36 94.16.23-36 42 362 63.22.36 – – – – –
38 94.16.23-38 44 361
382
63.22.3663.22.38
––
––
––
––
––
40 94.16.23-40 46 381
402
63.22.3863.22.40
––
––
––
––
––
42 94.16.23-42 48 401
422
63.22.4063.22.42
–63.28.42
––
–01.00284.042
––
––
44 94.16.23-44 50 421
442
63.22.4263.22.44
63.28.4263.28.44
– 63.32.44
01.00284.04201.00284.044
–01.00324.044
––
46 94.16.23-46 52 441
462
63.22.4463.22.46
63.28.4463.28.46
63.32.4463.32.46
01.00284.04401.00284.046
01.00324.04401.00324.046
––
48 94.16.23-48 54 461
482
63.22.4663.22.48
63.28.4663.28.48
63.32.4663.32.48
01.00284.04601.00284.048
01.00324.04601.00324.048
–05.95001.050
50 94.16.23-50 56 481
502
63.22.4863.22.50
63.28.4863.28.50
63.32.4863.32.50
01.00284.04801.00284.050
01.00324.04801.00324.050
05.95001.05005.95001.051
52 94.16.23-52 58 501
522
63.22.5063.22.52
63.28.5063.28.52
63.32.5063.32.52
01.00284.05001.00284.052
01.00324.05001.00324.052
05.95001.05105.95001.052
54 94.16.23-54 60 521
542
63.22.5263.22.54
63.28.5263.28.54
63.32.5263.32.54
01.00284.05201.00284.054
01.00324.05201.00324.054
05.95001.05205.95001.053
56 94.16.23-56 62 541
562
63.22.5463.22.56
63.28.5463.28.56
63.32.5463.32.56
01.00284.05401.00284.056
01.00324.05401.00324.056
05.95001.05305.95001.054
58 94.16.23-58 64 561 582
63.22.5663.22.58
63.28.5663.28.58
63.32.5663.32.58
01.00284.05601.00284.058
01.00324.05601.00324.058
05.95001.05405.95001.055
60 94.16.23-60 66 581
602
63.22.58–
63.28.5863.28.60
63.32.5863.32.60
01.00284.05801.00284.060
01.00324.05801.00324.060
05.95001.05505.95001.056
62 94.16.23-62 68 601
622
––
63.28.6063.28.62
63.32.6063.32.62
01.00284.06001.00284.062
01.00324.06001.00324.062
05.95001.05605.95001.057
64 94.16.23-64 70 621
642
––
63.28.6263.28.64
63.32.6263.32.64
01.00284.06201.00284.064
01.00324.06201.00324.064
05.95001.05705.95001.058
Reinforcement Ring with Hook
1 With a 2 mm cement layer
2 With a 1 mm cement layer
Original M.E. Müller Low Profile Cups
Original M.E. Müller® Low Profile Cup14
Instruments
for Original M.E. Müller Low Profile Cups
Tray instruments for low profile cup (complete)
ZS01.00245.626
Tray instruments for low profile cup (empty)
01.00245.627
Insert for tray instruments for
low profile cup (empty)
01.00245.628
Standard tray cover
01.00029.031
Cup impactor, curved
75.00.39
Cup impactor, straight
75.00.49
Positioning guide 40°
75.85.19
Positioning bar
75.85.00
Cup inserting device for cemented cups
(inner diameter)
∅ 22 mm 75.00.33
Top for impactor
black
∅ 22 mm 78.22.51*
blue
∅ 28 mm 78.28.51
green
∅ 32 mm 78.32.51
∅ 36 mm 05.95001.060*
Positioning top for low profile cups
blue
∅ 28 mm 75.28.94
green
∅ 32 mm 75.32.94*
black
∅ 36 mm 05.95001.059*
Positioning top for low profile cups, black
∅ 22 mm 75.22.94
* On special request
Test cup, low profile
∅ 36 mm 54.36.08
∅ 38 mm 54.38.08
∅ 40 mm 54.40.08
∅ 42 mm 54.42.08
∅ 44 mm 54.44.08
∅ 46 mm 54.46.08
∅ 48 mm 54.48.08
∅ 50 mm 54.50.08
∅ 52 mm 54.52.08
∅ 54 mm 54.54.08
∅ 56 mm 54.56.08
∅ 58 mm 54.58.08
∅ 60 mm 54.60.08
∅ 62 mm 54.62.08
∅ 64 mm 54.64.08
Original M.E. Müller® Low Profile Cup 15
Hi-Fatigue™* Bone CementFunction and Sense of Hi-Fatigue Bone Cement
Bone cement, in general, is a synthetic plastic material which is based on resin and related to acrylic glass. It is used:• For fixation of artificial joints1 • For the transfer load from the
implant to bone• As a shock absorber
Apart from anchoring the prosthesis, bone cement fulfils the function of transmitting the operating forces onto a bigger surface. Furthermore it acts as drug carrier (Hi-Fatigue G Bone Cement) and helps keeping the bone in a vital condition. The handling of bone cement is described mainly in four phases: mixing phase, waiting phase, application phase and setting phase. Zimmer brings in an additional, very important phase: the transport and storage phase. All of these phases are influenced by temperature and humidity.
Fatigue TestingDue to its unique formulation, Hi-Fatigue Bone Cement exhibits outstanding improvement in dynamic mechanical properties. This optimal characteristic results in greater reliability under long-term cyclical loading.
ViscosityThe special viscosity properties of Hi-Fatigue Bone Cement provide optimal handling without pre-chilling. The comfortable mixing phase of the cement with low-viscosity properties is followed by a short waiting time to “dough up.” The effective handling time results in an improved work-ability of the Hi-Fatigue Bone Cement.
Broad Spectrum of KillHi-Fatigue G Bone Cement contains Gentamicin, which has a broad spectrum of kill covering gram-posi-tive and gram-negative bacteria.2 As a premixed formulation, Hi-Fatigue G provides a homogenous cement/antibiotic mixture and saves valuable OR time.
Outstanding Release CharacteristicsHi-Fatigue G Bone Cement provides high local concentration of Gentami-cin. With 0.55 grams of Gentamicin, Hi-Fatigue G releases antibiotic over several days to reduce the risk of infection.3
Hi-Fatigue Bone Cement – Ideal Formula for SuccessHi-Fatigue Bone Cement can be applied universally in the ortho pedic world and offers a multiplicity of advantages:• Improved dynamic mechanical
properties• Optimal handling characteristics• Short mixing and waiting phase• Long working phase• Processing without precooling• Ideal for minimally invasive surgery
Ordering Information
Article Quantity REF
Hi-Fatigue 1x40 00-1120-140-01
Hi-Fatigue 2x40 00-1120-240-01
Hi-Fatigue G 1x20 00-1121-120-01
Hi-Fatigue G 2x20 00-1121-220-01
Hi-Fatigue G 1x40 00-1121-140-01
Hi-Fatigue G 2x40 00-1121-240-01
* Hi-Fatigue™ is a trademark of aap Biomaterials GmbH & Co. KG
1 Ascherl Rudolf. Science of Bone Cement, Ortho Supersite
2 Foerster, G. v., Buchholz, H. W., Heinert, K.: Die infizierte Huftendoprothese-Spätinfektion nach der 6. postoperativen Woche. In: Cotta, H., Braun, A. (Hrgs.), 124–135, 1988.
3 Data on file (aap Biomaterials GmbH & Co. KG)
Contact your Zimmer representative or visit us at www.zimmer.com
Copy
righ
t 200
9 by
Zim
mer
Gm
bH
Prin
ted
in S
wit
zerla
nd
Subj
ect t
o ch
ange
wit
hout
not
ice
Lit.No. 06.01600.012 – Ed. 01/2009 ZHUB
+H84406016000121/$090101A09S