EVOLUTION® BIOFOAM® BROCHURE
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Evolution Evolution® BioFoam® Tibial System Medial-Pivot Knee System For Cementless Tibial Fixation Fixation with Bite

TABLE OF CONTENTS 2 Introduction 3 Rising Demands for Cementless Fixation 4 MicroPort Orthopedics’ Legacy in Cementless TKA 6 Clinical Success of BioFoam® Fixation 7 RSA Data Summary 8 True Trabecular Architecture 9 Compressive Strength 10 Frictional Properties 11 Economic and Procedural Benefits Introduction Total knee arthroplasty has long been accepted as a means of relieving pain and providing patients with a long-term solution for osteoarthritis of the knee. However, with the advent of newer technologies in the orthopedic industry, TKA has subsequently become more readily demanded by a...

Rising Demands for Cementless Fixation Kurtz et al. reviewed the US National Inpatient Sample in 2006 and reported that approximately 70,000 TKA’s were performed for patients under the age of 55 years. Extrapolating trends in the ever-growing demand of TKA, Kurtz et al. projected that by 2030 there could be up to one million TKA’s performed in the US for patients under 55 years.1 Figure 1 In 2014 Meehan et al. conducted a study from the California Patient Discharge Database of over 120,000 TKA’s determining there is a 4.7 times greater risk of revision due to aseptic loosening in patients...

MicroPort Orthopedics’ Legacy in Cementless TKA Since the early 1980’s with the launch of Dr. Leo Whiteside’s cementless Ortholoc® I Knee System, MicroPort Orthopedics (formerly Wright® Medical Technologies) has been a pioneer in the field of cementless TKA. The Ortholoc® and Advantim® tibial bases were reported in CORR to have 98.6% survivorship at 18 years for loosening.6 The addition of BioFoam® Cancellous Titanium to the eMP™ Medial-Pivot Knee System is the next generation in cementless TKA designs.  Addition of pegs, screwholes, and cylindrical stem. Fins angled posterior for...

Evolution® Medial-Pivot with BioFoam®  Clinical success of Advance® BioFoam® continued into Evolution® tibial component.  Modular system offering customizable fixation.  Screw and screwhole bases available. Advance® Medial-Pivot with BioFoam® Tibial System  Highly porous cancellous titanium on modular tibial component.

Clinical Success of BioFoam® Fixation Initial and short-term fixation of cementless tibial implant is critical to early patient satisfaction and long-term biologic ingrowth. A recent 2015 study by Waddell et al demonstrated strong evidence early radiographic and functional outcomes.7 Early radiographic and functional outcomes of a cancellous titanium-coated tibial component for total knee arthoplasty D. D. Waddell1 • K. Sedacki2 • Y. Yang2 • D. A. Fitch2 Study Highlights:  104 TKA’s performed in 85 subjects by four surgeons  Subjects were evaluated preoperatively, and at 6, 12, and 24...

RSA Data Summary 2 Year Clinical Report using RSA to Evaluate Fixation of the BioFoam® Advance® Total Knee Arthroplasty Components with and without Screw Augmentation8 Figure 3 Report Highlights:  49 subjects were assessed at 6, 12, and 24 months.  Pattern of initial fixation followed by stabilization.  Low bone mineral density (BMD) changes over the two years.  Migration was found to be not significantly different from the Trabecular Metal™ Tibial Component.  Addition of screw fixation did not significantly improve fixation over the two years. Maximum Total Point Motion (mm) No Screws...

True Trabecular Architecture The structure of BioFoam® Cancellous Titanium acts as a biological scaffold designed to allow fast, fluid bone ingrowth. Osteoblasts are able to cling to the course titanium struts; conducting angiogenesis through the interconnecting pores.9 These same biologic pathways allow the body to create a living implant/bone interface leading to longer implant survivorship. Looks like bone, acts like bone.  60-70% Porous16  Full Interconnecting Porosity  Manufactured from Commercially Pure (CP) Titanium Metal  Osteoconductive Matrix

Compressive Strength Cancellous or trabecular bone is composed of a network of rod- and plate-like elements that provide porous macrostructure for blood vessels and marrow. Trabecular bone accounts for only 20% of total bone mass, but has nearly ten times the surface area of compact bone.10 PORE CELL The structure of BioFoam® Cancellous Titanium resembles that of trabecular bone. The pore cell size averages 530μm and the diameter of interconnecting pores averages 200μm.16 Figure 4 The porosity is between 60-70%, demonstrating equivalent compressive and flexural strength to commercially...

Frictional Properties Roughened to Enhance Immediate Fixation  Coarse Struts “Bite” into bone  Provides initial Scratch-fit 100X Magnification BioFoam® Cancellous Structure BioFoam® Roughened Bone Interface High Coefficient of Friction11  Coefficient of friction of BioFoam® cancellous titanium, Trabecular Metal™ (Zimmer Inc., Warsaw, IN), Titanium plasma spray, and Titanium porous sintered beads. Figure 6  Ten artificial bones tested on a biaxial test machine.  65 N vertical load applied to contacting surfaces.  Horizontal displacement was applied at a rate of 0.025 mm/sec. Trabecular...

Economic and Procedural Benefits OR Efficiency and Cost Savings  Kamath et al. reported an average 12 minutes less of tourniquet time with cementless fixation.12  Shippert et al. reviewed time-dependent costs at 100 US hospitals and determined an average cost per minute of $62.13 By extrapolating these examples and analyzing the savings generated by time gained, cementless TKA could save on average nearly $750 per case. No Change to Technique  Cemented and cementless femoral and tibial preparation utilizes the same instrumentation with screwless fixation.

References 1. Kurtz et al. Future young patient demand for primary and revision joint replacement: national projections from 2010 to 2030. Clin Orthop Relat Res. 2009 Oct; 467(10):2606-12. 2. Freeman MA, Pinskerova V. The movement of the knee studied by magnetic resonance imaging. Clin Orthop Relat Res. 2003;410:35-43. 3. Meehan et al. Younger Age Is Associated with a Higher Risk of Early Periprosthetic Joint Infection and Aseptic Mechanical Failure After Total Knee Arthroplasty. J Bone Joint Surg Am, 2014 Apr 02; 96 (7): 529 -535 . http://dx.doi.org/10.2106/JBJS.M.00545. 4. Duffy et al....