Orthopaedics
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Restoration
®Acetabular Wedge Augment System
Design Rationale
Material
The Restoration Acetabular Wedge Augments are manufactured from patented Tritanium1Advanced
Fixation Technology. Tritanium is created using com-mercially pure Titanium (CPTi)—a biologically compatible material. The Titanium matrix, resulting in a porous bulk foam structure, closely resembles trabecular bone (Figure 1).2
Wedge Augment material characteristics include: Average Porosity: 63%3
Coefficient of friction: 1.014
Advanced Fixation– Tritanium Porous Technology,
optimized screw placement
Versatility– Broad range of implant sizes, adaptable implant geometry and orientation for various defects
Simplicity– Minimal bone removal, simplified trial to implant placement, intuitive and streamlined instrumentation
Restoration Acetabular Wedge
Augments, united with Tritanium,
Trident, MDM and X3 technologies,
is an evolutionary advantage in
Total Hip Arthroplasty
Advanced Fixation
Versatility
Simplicity
Restoration Acetabular Wedge Augments are designed to aid in the reconstruction of minimal to severe bone defects. They provide intraoperative flexibility through optimized screw placement and versatile implant siz-ing and positionsiz-ing.
Ancillary Fixation
Each Wedge Augment is designed to optimize the number of screw hole options and screw placement to provide enhanced initial stability of the augment.5Each
screw hole allows for a varying degree of angulation, up to 18°, to help achieve purchase with good bone. Either GAP (2080-00XX) or Osteolock (5260-5-0XX) 6.5mm screws can be used to obtain rigid fixation of the Wedge Augment against host bone.
Restoration Acetabular Wedge Augment Trials Final
Construct
Use of K-wires to place Restoration Acetabular Wedge Augment
Instrumentation
Ease of Use
The Restoration Wedge Augment instruments, encom-passed in a single tray, are simple and easy to use for trialing and implantation. The system is streamlined to include Wedge Augment Trials and a small number of Core Instruments for procedural simplification. The Wedge Augment Trials mimic the geometry of the implants and are color-coded according to OD size. Each trial has the same screw hole configuration as the implant to serve as a visual aid for the location of screws.
Simplified Placement
The Restoration Acetabular Augment system was designed with provisions for Kirschner Wires (K-wires) to simplify the placement of the trials and to help the surgeon replicate trial positioning with the implant.
66mm OD 62mm OD 58mm OD
Restoration Acetabular Wedge Augment Optimized screw hole placement Restoration Modular Cone Body Restoration Modular Conical Distal Stem 18 Wedge Sizes in 3 Thicknesses Up to 18° of angulation Tritanium Advanced Fixation Technology
Product Specifications
The Wedge Augments are offered in 18 differ-ent sizes consisting of six outer diameter (OD) sizes. The OD sizes range from 46mm to 66mm in 4mm increments. The correspon-ding inner diameter (ID) for each size is 2mm larger than the OD. For each wedge augment, there are three thickness options. See Table 1.
Table 1
Wedge Features
Tritanium bulk foam
Range of OD sizes and thickness for spectrum of defects
Optimized screw holes
K-Wire holes for simplified placement
Outer Inner No. of Diameter Diameter Thickness Screw Catalog # (mm) (mm) (mm) Holes 5096-4615 46 48 15 3 5096-4620 46 48 20 4 5096-4625 46 48 25 4 5096-5015 50 52 15 3 5096-5020 50 52 20 4 5096-5025 50 52 25 4 5096-5415 54 56 15 4 5096-5420 54 56 20 6 5096-5425 54 56 25 6 5096-5815 58 60 15 6 5096-5820 58 60 20 6 5096-5825 58 60 25 6 5096-6215 62 64 15 6 5096-6220 62 64 20 8 5096-6225 62 64 25 8 5096-6615 66 68 15 6 5096-6620 66 68 20 8 5096-6625 66 68 25 8
Restoration Acetabular Wedge Augment Specifications
K-wire Holes
The Restoration Modular Stem System
Advanced
Bearing Options
MDM X3
The MDM X3 Mobile Bearing Hip System is the latest addition to Stryker’s comprehensive solution for both primary and revision total hip arthroplasty (THA). MDM X3 is designed to address stability,6implant
longevity7and advanced fixation—helping orthopaedic
surgeons with a wide breadth of reconstruction chal-lenges they may face in hip surgeries.
Tritanium, Trident and X3
Tritanium Advanced Fixation Technology, developed from commercially pure Titanium (CPTi)—a biologi-cally compatible material, is applied to Stryker’s Multi-Hole shell to aid in revision THA.
Trident, an evolutionary shell design with over 10 years of clinical history, has demonstrated the lowest revision rate (2.4%) among cementless cups at five years according to the 2010 National Joint Registry of England and Wales.8
Both the Tritanium and Trident Acetabular Systems feature a patented15locking mechanism that
outper-forms competitive designs in laboratory testing,9and is
designed to minimize backside wear9and maximize
jump distance for increased stability.10Compatible with
X3 Advanced Bearing Technology, Tritanium and Trident provide solutions for the range of hip surgeries.
The Power of X3
The patented16X3 Advanced Bearing Technology
is designed to minimize the risk of wear and con-sequently help prolong the life of the implant.7,11
X3 has demonstrated a 97% reduction in wear compared to conventional polyethylene.11
Advanced
Femoral Options
Restoration Modular
The Restoration Modular Stem System is designed to allow surgeons to independently achieve the main goals of hip surgery—attain solid fixation and restore hip biomechanics,12all with a straightforward set of
instrumentation.
Versatility
System addresses femoral Type 1 through Type 4 revisions13,14
Stability
Designed to allow for restoration of proper biome-chanics through independent adjustment of leg length, offset and version12
Simplicity
Simple, straightforward instrumentation to allow for OR efficiency
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trade-marks or service trade-marks: MDM, Osteolock, Restoration, Stryker, Trident, Tritanium, X3. All other tradetrade-marks are trademarks of their respective owners or holders.
Literature Number:LRWS-B KAM/GS 8/11 165 Copyright © 2011 Stryker Printed in USA. References 1. US Patent #7,458,991, 7,740,795, 7,674,426.
2. Ricci J. L., Kauffman J., Jaffe W., et al., “Comparison of Osseointegration and Bone Adhesion to Commercially Pure Titanium and Titanium Alloy,” 23rd Ann. Mtg. Society for Biomaterials, 1997.
3. Stryker Test Report RD-10-044 4. Stryker Test Report RD-07-077 5. Stryker Test Report RD-10-050
6. Heffernan, C. , Bhimji, S., Macintyre, J., et al. (2011). Development and Validation of a Novel Modular Dual Mobility Hip Bearing. ORS Annual Meeting Poster #1165.
7. Herrera, L., Lee, R., Longaray, J., et al. (2010). Edge Loading Wear due to Inclination Angle for Three Contemporary Hip Bearings. 56th Annual ORS Meeting. Poster #2259.
8. The National Joint Registry of England and Wales, Annual Report 2010. Table 3.3. Based on revision rates according to cup brands for primary hip replacement procedures, undertaken between 1st April 2003 and 31st December 2009, which were linked to a HES/PEDW episode.
9. Litsky, AS, et al., “Micromotion between the Cup and the Liner in Modular Acetabular Prostheses,” 1999 Society for Biomaterials, 25th Annual Meeting Transactions.
10. Nevelos, J., Bhimji, S., Macintyre, J., et al. (2010). Acetabular Bearing Design has a Greater Influence on Jump Distance than Head Size. 56th Annual ORS Meeting: Poster #2028.
11. Stryker Orthopaedics Restoration® ADM X3® 28 mm ID acetabular inserts made of X3® Gas Plasma Sterilized UHMWPE, show a 97% reduction in volumetric wear rate versus 28 mm ID Restoration® ADM Duration Gamma Radiation Sterilized UHMWPE. Both ADM constructs utilized a 54mm OD shell and the inserts were approximately 9.9 mm thick. Testing was conducted under multi-axial hip joint simulation for 5 million cycles using a 28mm CoCr modu-lar femoral head articulating counterface and calf serum lubricant. Volumetric wear rates were 109.7±6.0 mm3/106cycles
and -1.03 ± 3.8 mm3/106cycles for Duration and X3 polyethylene insert test samples. Although in-vitro hip wear
simula-tion methods have not been shown to quantitatively predict clinical wear performance, the current model has been able to reproduce correct wear resistance rankings for some materials with documented clinical results.1-3
[1] Wang, A, et. al., Tribology International, Vol. 31, No. 1-3: 17-33, 1998. [2] Essner, A. et. al., 44th Annual Meeting, ORS, New Orleans, Mar. 16-19, 1998: 774. [3] Essner, A. et. al., 47th Annual Meeting, ORS, San Francisco, Feb. 25-28, 2001: 1007.
12. Goldberg G, Hozack WJ. Modular Stems for Revision of Peri-prosthetic Hip Fractures: Indications and Technique. Seminars in Arthroplasty 2006 17: 15-17.
13. Patel PD, Klika AK, Murray TG, Elsharkawy KA, Krebs VE, Barsoum WK. Influence of Technique With distally fixed Modular Stems in Revision Total Hip Arthroplasty. Journal of Arthroplasty 2010. 25: 926-931.
14. Holt G, McCaul J, Jones B, Ingram R, Stark A. Outcome After Femoral Revision Using the Restoration Cone / Conical Femoral Revision Stem. OrthoSuperSite. January 2011.
15. US Patent # 6,475,243.
16. US Patents # 7,517,919 , 7,714,036.
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