Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico...

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Transcript of Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico...

Page 1: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

Product Information

Supporting healthcare professionals

Page 2: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

Rectangular taperThe rectangular cross section of the SL-PLUS MIA stem requires minimum excavation of the medullary canal.3 The cortical support at the edges provides optimum primary anchorage and leaves enough room for the bone to be supplied with nutrients from the medullary cavity.

Dual taper principleWith the precisely defined taper angle, multiple cortical contacts are achieved along the entire length of the stem. This allows the load to be transferred in both projection planes The relationship between X and Y is the same for the SL-PLUS MIA stem and SL-PLUS stem, while the design in the main anchorage zone Y has remained unchanged.

The evolution of the GOLD STANDARD™It all started with the philosophy to develop a universal hip system that can be used by young and older patients alike to relieve hip pain and restore hip motion. 8,13,17-19

The SL-PLUS™ MIA Ti/HA stem as the latest member of the SL-PLUS™ family is based on the extensively tried-and-tested Zweymüller SL-PLUS™ Standard stem with over 20 years of clinical experience.8 The SL-PLUS MIA stem was specially developed for use in minimally invasive surgical techniques. The design adaptation aimed to simplify the surgical procedure1,2,20,25 and to ensure stem implantation with reduced lateral bone resection.1,20 This will ensure better trochanteric bone stability by minimizing the risk of a fracture and guarantees maximum preservation of the tendon insertions on the greater trochanter.1,2,20

The successful biological anchoring concept, a dual-tapered straight stem with a rectangular cross section, has remained an integral part of the design.8,15-19,22,23

Thanks to the comparable design characteristics and anchorage principles, excellent clinical long-term results are expected, as with the SL-PLUS stem.

3-point locking

Cortical support along its length

X

Y

2 Product Information - SL-PLUS™ MIA Cementless Femoral Hip System

Page 3: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

Design Rationale

MIS-friendly design

The adapted design allows the broaches and the stem to be introduced in a curved manner. This reduces bone resection in the trochanteric region, maximizes preservation of the tendon insertions and protects muscles and skin.1,2,20

Pyramid shaped tip

The taper at the prosthesis tip is rounded and changes smoothly into a pyramid-shaped tip. This shall allow a physiological transfer of forces to the implant tip, which may result in reduced tension peaks in the distal diaphyseal area.

High primary stability

The dual-tapered straight stem with its rectangular cross section is based on the SL-PLUS design, which has been shown to provide excellent primary and rotational stability in the cortical bone. This, in turn, leads to favourable load distribution by transmitting it in both projection planes and minimises the risk of subsidence of the implant.

Freedom of movement

The neck is designed to provide an optimum balance between the greatest possible range of motion (ROM) and high strength. The polished surface minimises the risk of irritation in case of contact with the adjacent soft tissues or impingement with the acetabularcup.28

The point of reference

The shoulder serves as the reference point for the preoperative planning, medullary canal preparation and stem implantation. Furthermore, it contains a 6 mm extraction thread along the stem axis.

Improved secondary stability

The INTEGRATION-PLUS™ multi layer Ti/HA coating in the proximal area leads to accelerated and increased bone on-/in-growth with the aim of avoiding radiolucent lines by enhancement of load transmission in the metaphyseal region.4-9, 27

Well adapted product range

With its anatomically adapted size distribution it matches nearly every patient and helps restore the biomechanical center, offering a standard stem with a CCD angle of 131° and a lateral option with 123°.

Product Information - SL-PLUS™ MIA Cementless Femoral Hip System 3

Page 4: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

Optimal Stem RangeThe SL-PLUS MIA system offers a total of 26 stem options: 14 sizes for the Standard and 12 sizes for the Lateral option. The specific size increments were developed by a computer-assisted series of measurements, so that the system can provide an optimal fit and facilitate the intraoperative choice of the correct size. This distinct design of anatomical adapted size increments is an important advantage of this system.

Sizes Length (L) in mm

Standard Ti/HA131° CCD

Lateral Ti/HA123° CCD

01 128 75000172

0 132 75000173

1 137 75000174 7500186

2 141 75000175 7500187

3 145 75000176 7500188

4 150 75000177 7500189

5 154 75000178 7500190

6 159 75000179 7500191

7 163 75000180 7500192

8 168 75000181 7500193

9 173 75000182 7500194

10 178 75000183 7500195

11 183 75000184 7500196

12 188 75000185 7500197

4 Product Information - SL-PLUS™ MIA Cementless Femoral Hip System

Page 5: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

Pyramid shaped tip The taper at the prosthesis tip is rounded and changes smoothly into a pyramid-shaped design. This may result in reduced tension peaks in the distal diaphyseal area.

Two Offset Options The restoration of the anatomically correct offset is of prime importance and so the SL-PLUS stem is available in two offset options:

• Standard stem: 131° CCD angle

• Lateral stem: 123° CCD angle

The offset increases proportionally while the height of the rotation center remains equal for the lateralized stems, but gives an additional offset of +6 to +9mm with a ball head M/+4.

Additional Offset in mm with Lateral stem:

Sizes Ball head28 XS/-3

Ball head28 M/+4

Ball head28 XL/+12

1 +6 +6 +7

2 +6 +6 +7

3 +6 +6 +7

4 +6 +7 +7

5 +6 +7 +8

6 +7 +7 +8

7 +7 +7 +8

8 +7 +8 +8

9 +7 +8 +9

10 +8 +8 +9

11 +8 +8 +9

12 +8 +9 +9

+ Offset

Center ball

head 28/M

SL-PLUS MIA

Lateral stem

Center ball head

28/M

SL-PLUS MIA

Standard stem

Product Information - SL-PLUS™ MIA Cementless Femoral Hip System 5

Page 6: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

INTEGRATION-PLUS™: EXCELLENT PRIMARY AND SECONDARY STABILITYThe base material of the SL-PLUS MIA stem is a forged and corundum blasted Ti-6Al-7Nb alloy with a surface roughness of Ra 4-8 µm. The proximal part is additionally Vacuum Plasma Sprayed (VPS) with a 0.3 mm open-pore titanium plasma layer and a 0.05 mm hydroxyapatite (HA) layer.

Advantage of the VPS Ti/HA coating

The open-pore titanium layer more than doubles the surface and its roughness and therefore increases bone on-/in-growth.7,21

HA coating facilitates bone cell attachment and bone deposition (surface coverage), supporting osserrointegration.6,10,19,21

The bond strength of the HA coating is improved thanks to a mechanical interlock with the roughened Ti surface. This prevents coating delamination.7,10

In the event of local HA resorption, the underlying roughened Titanium-Plasma-Spray layer encourages osseointegration.7

What are the advantages of Vacuum Plasma Spraying?

Plasma spraying is a well-established coating process that is widely available and well accepted.10-12

Implant fatigue resistance superior to sintered porous surfaces7.

Increased purity and adhesive strength compared to other processes (e.g. APS Atmospheric Plasma Spray).7

The histology from an explanted SL-PLUS MIA Ti/HA stem confirms that HA can facilitate implant osseointegration in the early postoperative period:

Histology after 4 months*

Histology after 4 months*

Bone adjacent to the HA coating

Ti-base material

The magnification shows the bonegrowing through the HA coating

Electron microsope scans:

Implant cross-section showing the Ti/HA coating

Innovative Ti/HA coating of a stem surface; mean roughness Ra approx. 20–30 µm. (Stereomicrograph, x 20, SL-PLUS with INTEGRATION-PLUS)

VPS HA coating

VPS Ti porous layer

VPS Ti base layer

Ti substrate

*Image courtesy of OA Priv.-Doz. Dr. Monika Huber, SMZ Otto Wagner Hospital, Pathological- Bacteriological Institute, Vienna

6 Product Information - SL-PLUS™ MIA Cementless Femoral Hip System

Page 7: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

Clinical Results

Case follow-ups

Title / Reference N (hips) Follow-up

WEI Bo, WANG Liming, JIN Chengzhe, XU Yan. PRELIMINARY CLINICAL APPLICATION OF SL-PLUS MIA FEMORAL

STEM PROSTHESIS IN TOTAL HIP ARTHROPLASTY. Chinese Journal of Reparative and Reconstructive Surgery,

March 2013, Vol. 27, No.325

38 13.6 months

J. E. Brandenberg, U. Steiger. The SL-Plus-Mia-stem – Results after 1000 implantations. Deutscher Ärzte-Verlag

OUP, 2012; 1 (5).23

1’000 5 years

G. Pflüger. 4 Jahre minimal-invasive HTEP mit dem SL-MIA-Schaft. Was hat sich bewährt? Was hat sich

geändert? JATROS Unfallchirurgie & Sporttraumatologie 2, 201022

200 1 year

G. Pflüger, S. Junk-Jantsch, J. Bonomo. The bioactive hydroxypaptite coated SL-PLUS TiHA MIA stem in MIS.

Clinical and radiological results after minimally invasive THR. Poster SICOT 2010.5

1’865 1 year

S. Junk-Jantsch, G. Pflüger. MIS and the Demands onBearing Couples, Bioceramics and Alternative Bearings in

Joint Arthroplasty. Ceramics in Orthopaedics 2007, pp. 329-340.1

342 NA

Preop: Female patient, 57 years, right hip

Preop: Male patient, 81 years, left hip

6 days post-op: SL-PLUS MIA Ti/HA w. BICON-PLUS

3 months follow-up: SL-PLUS MIA w. R3 following THA on the left hip.

3.5 years post-op: well osseointegrated SL-PLUS MIA stem with a visible mini sclerosis around the Ti/HA coated area

3 months follow-up: SL-PLUS MIA w. R3 implanted following THA on the left hip.

Case 1 (Courtesy of Primarius Univ.-Prof. Dr. med. Peter Ritschl, Vienna)

Case 2 (Courtesy of Primarius Univ.-Prof. Dr. med. Peter Ritschl, Vienna)

Product Information - SL-PLUS™ MIA Cementless Femoral Hip System 7

Page 8: Product Information · Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics

References1. S. Junk-Jantsch, G. Pflüger. MIS and the Demands on Bearing Couples, Bioceramics and Alternative Bearings Joint Arthroplasty. Ceramics in Orthopaedics 2007, pp 329-340 [abstract]. 2. J. E. Brandenberg, U. Steiger. The SL-Plus-Mia-stem – Results after 1000 implantations. Deutscher Ärzte-Verlag, OUP, 2012; 1 (5). 3. Todd V. Swanson. The Tapered Press Fit Total Hip Arthroplasty. A European Alternative. The Journal of Arthroplasty Vol. 20 No. 4 Suppl. 2 2005. 4. K.A. Zweymüller. Bony Ongrowth on the Surface of HA-Coated Femoral Implants: An X Ray Analysis. Z Orthop Unfall 2012; 150: 27–31. 5. S. Junk-Jantsch, G. Pflüger. The bioactive hydroxyapatite coated SL-PLUS TiHA MIA® stem in MIS. Clinical and radiological results after minimally invasive THR. Poster SICOT 2010. 6. Z. Strnad, J. Strnad, C. Povýšil, K. Urban. Effect of plasma sprayed hydroxyapatite coating on osteoconductivity of commercially pure titanium implants. Int. J. Oral. Maxillofac Implants Vol.15, No. 4, 2000. 7. Hans Schmotzer, Sara Ulrich. Osseointegration. Different surface textures and coatings of cementless orthopaedic implants. July 2000. 8. K. Zweymüller. Good results with an uncoated grit-blasted tapered straight stem at ten years. Interact Surg (2007) 2: 197–205. 9. W. Steens, A. G. Schneeberger, R. Skripitz, P. Fennema, C. Goetze. Bone remodeling in proximal HA-coated versus uncoated cementless SL-Plus femoral components: a 5-year follow-up study. Arch Orthop Trauma Surg. 2010. 10. H. Gruner. Plasma spraying for medical application. European Cells and Materials Vol. 10. Suppl. 1, 2005 (page 1). 11. J. A. N. Shepperd, H. Apthorp. A contemporary snapshot of the use of hydroxyapatite coating in orthopaedic surgery., JBJS 2005. 12. Antonio Herrera, Jesús Mateo, Jorge Gil-Albarova, et al. Cementless Hydroxyapatite Coated Hip Prostheses., Hindawi Publishing Corporation BioMed Research International, Volume 2015, Article ID 38646. 13. Saverio Affatato, Saverio Comitini, Matteo Fosco, Aldo Toni, Domenico Tigani. Radiological identification of Zweymüller-type femoral stem. International Orthopaedics (SICOT) 2016. 14. Panagiotis Korovessis, Thomas Repantis, Andreas ZaWropoulos. High medium-term survivorship and durability of Zweymüller-Plus total hip arthroplasty. Arch Orthop Trauma Surg (2011) 131:603–611. 15. Gerold Labek, Simon Kovac, Vesna Levasic, Wolfgang Janda, Luigi Zagra. The outcome of the cementless tapered SL-Plus stem: an analysis of arthroplasty register data. International Orthopaedics (SICOT) (2012) 36:1149–1154. 16. Peteris Studers, Danils Belajevs, Vitolds Jurkevics, Peteris Likums. Ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population. International Orthopaedics (SICOT) 2015. 17. Jan Schmolders, Grigoris Amvrazis, Peter H. Pennekamp, et al. Thirteen year follow-up of a cementless femoral stem and a threaded acetabular cup in patients younger than fifty years of age. International Orthopaedics (SICOT) 2016. 18. Egbert J. D. Veen, Joost C. M. Schrier, Esther Van’t Riet, Mark J. Breslau, Alexander F. W. Barnaart. Outcome of the Cementless Zweymüller BICON-PLUS Cup and SL-PLUS Stem in the Very Elderly Individuals. Geriatric Orthopaedic Surgery & Rehabilitation, 2016, Vol. 7(2) 74-80. 19. Karsten Ottink, Lex Barnaart, Robin Westerbeek, Karin van Kampen, Sjoerd Bulstra, Hans-Peter van Jonbergen. Survival, clinical and radiological outcome of the Zweymüller SL/Bicon-Plus total hip arthroplasty: a 15-year follow-up study. Hip Int 2015; 25 (3): 204-208. 20. G. Pflüger, S. Junk-Jantsch, V. Schöll. Adaptation of the Zweymüller stem (SL-PLUS® stem) for minimally invasive hip surgery: Experiences after 1½ year. Poster EFORT 2007. 21. F. Lintner, M. Huber, G. Böhm, K. Zweymüller. The Ti/hydroxyapatite-coated PLUS hip endoprosthesis stem: Is a coating necessary? 25 years of Biologic Fixation, Elsevier 2007. 22. G. Pfluger, S. Junk-Jantsch, J. Bonomo. 4 Jahre minimal-invasive HTEP mit dem SL-MIA-Schaft. Was hat sich bewährt? Was hat sich geändert? JATROS Unfallchirurgie & Sporttraumatologie 2, 2010 23. J. E. Brandenberg, U. Steiger. The SL-Plus-Mia-stem – Results after 1000 implantations. Deutscher Ärzte-Verlag OUP 2012; 1 (5) 24. Smith & Nephew Bone&JointOutcome SL-PLUS, Vol 04, No 02, Sep 2017 25. WEI Bo et al. Preliminary Clinical Application of SL-PLUS MIA Femoral Stem Prosthesis in Total hip Arthroplasty. Chinese Journal of Reparative and Reconstructive Surgery, March 2013, Vol. 27, No.3 [abstract]. 26. Huber et al. Histology Of Tissue Adjacent To Proximally Hydroxyapatite Coated Femoral Endoprosthesis Stems. Poster EFORT 2017. 27. Haffner et al. Clinical and radiological outcomes following THA using the Hydroxyapatite-Coated SL-PLUS◊ MIA Stem. 2 to5 year analysis of a 10-Year, prospective, multi-centre, uncontrolled, observational trial. Poster EFORT 2017. 28. Olivier Guyen, Vincent Pibarot, Gualter Vaz, Christophe Chevillotte, Jacques Be´jui-Hugues. Use of a Dual Mobility Socket to Manage Total Hip Arthroplasty Instability. Clin Orthop Relat Res (2009) 467:465–472.

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