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\title{Evaluation of the Quantification of Bone Ingrowth and the Influence of Stress Shieldings in Cementless Total Knee Arthroplasty: A Prospective Case â? "Control Study}
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             \author[1]{Takao  Kaneko}

             \author[2]{Takahiro  Otani}

             \author[3]{Takahide  Sunakawa}

             \author[4]{Hiroyasu  Ikegami}

             \author[5]{Yoshiro  Musha}

             \affil[1]{  Toho University School of Medicine}

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\date{\small \em Received: 13 December 2015 Accepted: 2 January 2016 Published: 15 January 2016}

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\begin{abstract}
        


There have been no manuscripts to compare the bone ingrowth between CR type (Cruciate Retaining) and PS type (Posterior Stabilized) of cementless total knee arthroplasty(porous tantalum metal modular tibial component) and evaluate by imaging the postoperative computed tomography. The purpose of this study was to clarify and compare the bone ingrowth under the peg of porous tantalum modular tibial component between CR and PS.Methods: A consercutive series of 46 total knee arthroplasties (CR:23,PS:23) were reviewed prospectively. We was divided mediolaterally into six regions under the peg of tibial component and analyzed bone mineral content/total volume (BMC/TV)values using 3D osteomorphometry software with MDCT under lower the knee every 3 months(follow-up:21 months).

\end{abstract}


\keywords{porous tantalum modular tibia cementless total knee arthroplasty analysis of three-dimensionally osteomorphometry bone mineral content/total volume (B}

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\let\tabcellsep& 	 	 		 
\section[{I. Introduction}]{I. Introduction}\par
emented total knee arthroplasty has been considered the accepted standard with predictable and durable results  {\ref [3.4.8.9.10.16. 21.22.25.28.29}]. Cementless total knee arthroplasty have induced preservation of bone stock, shoter operating time, ease of revision. Porous tantalum has been introduced as metallic implant material for total knee arthroplasty. The high volumetric porosity (70 \textasciitilde  80\%), low modulas of elasticity (3\textasciitilde 4 MPa), and high friction characteristics of trabecular metal make it conducive for biological fixation  {\ref [17]}. Many groups have reported satisfactory outcomes with cementless total knee arthroplasty using trabecular metal monoblock tibial components that contain porous tantalum as the primary material  {\ref [5.9.14.18. 24.34}].All reports was used trabecular metal monoblock and radiostereometric results for stastical analysis. No manuscript were evaluated by imaging the postoperative computed tomography. We hypothesized that trabecular metal modular type (posterior stabilized type: PS type) is affected the influence of stress shielding with mid flextion instability. The aim of present study was to compare the bone ingrowth under the peg of trabecular metal modular tibial component between cruciate retaining type (cruciate retaining: CR type) and PS type. 
\section[{II. Material and Methods}]{II. Material and Methods}\par
From October 2011 to April 2013, 46 primary total knee arthroplasties were perfomed in 46 patients with porous tantalum modular tibial component (Trabecular Metal; Zimmer, Warsaw, IN). We divided CR and PS type selectively. In all cases, the TKA surgical procedure was performed by one author (T. K.) and was minimally invasive surgery, with a skin incision of 8-11 cm. Patient walking was permitted from the day following the operation. The Knee Society Score (KSS) and The Western Ontario Mcmaster Universities Osteoarthritis Index (WOMAC) were measured preoperarively and up to two years postoperatively by two authors (T.K and T.O). Some case in which postoperative simple X-ray examination and, 3D Planning reposition simulation postoperative evaluation (ZedKnee: LEXI. Co., Ltd, Tokyo. Japan) showed malalignment and, cases was excluded from the analysis. We dicided that inclusion criteria was that all cases of tibial component alignment was within 3°varusvalgus to neutral alignment. For determination of the ossification density at 3,6,9,12,15,18,21 months postoperatively, a phantom(Taisho-Toyama Pharm. Co., Ltd, Tokyo. Japan ) consisting of a cylinder composed of a material corresponding to cortical bone and filled with a material having a bone density corresponding to cancellous bone was placed under the knee (Fig.  {\ref 1}), and imaging was then performed by multi detector-row computed tomography (MDCT). From the obtained images, the cancellous trabecular structure was visualized three-dimensionally with 3D osteomorphometry software (TRI/3D-BON64; RATOC System Engineering Co., Ltd., Tokyo, Japan), and the structural parameters were calculated (Fig.  {\ref 2}). The structural parameters subjected to analysis were those recommended by the American Society for Bone and Mineral Research [19]: bone mineral content/total volume (BMC/TV) values, representing mineralized bone volume as a percentage of total volume. In the assessment of BMC/TV values by MDCT imaging of the proximal tibia, the joint prosthesis itself generated artifacts, which prevented accurate delineation. Therefore, the overall region was divided into 6 regions of interest (ROIs), consisting of two cylindrical volumes, each 16 mm in diameter and 8 mm in height, with their tops 0.6 mm below the medial or lateral peg, with each further divided into 2 half-cylinders. [ROI. 1 (Medial), ROI. 2 (Lateral), ROI. 3 (Medial-Anterior), ROI. 4 (Medial-Posterior), ROI. 5 (Lateral-Anterior), and ROI. 6 (Lateral-Posterior) (Fig.  {\ref 3}). Statistical analysis(SPSS version 17.0 software: SPSS, Chicago, IL, USA) was performed for relative change in ossification density ,immediately and after surgery every 3 months in each of the two groups by the Mann-Whitney U test and for comparison between the two groups by the paired t-test. P values of less than 0.05 were considered significant .This study of these patients was approved by the Institutional Review Board and they were informed of the risk of radiation exposure required 
\section[{III. Results}]{III. Results}\par
No significant difference was recognized in age and Body mass index, gender, knee society score, between two groups before the operation (Table  {\ref .} 1).No osteoporosis therapeutic agent was administered in the two groups .There were no significant difference in KSS and WOMAC at 1-year follow-up between the two groups (Table  {\ref .} 2). No prosthetic fracture and prosthetic migration and prosthetic infection were detected during the follow-up periods. At 3.6.9.12.15.18.21 months after operation, the BMC/TV values in ROI. 1 (Medial) was no significant difference in the two groups (Fig .  {\ref 4}). The BMC/TV values in ROI. 2 (Lateral) was significant higher in PS type than CR type at 3 and 18. 21 months after operation (p<0.01, p<0.05. Fig . \hyperref[fig_1]{5}).\par
The BMC/TV values in ROI. 3 (medial-anterior) and ROI.4 (Medial-Posterior) was no significant difference in both group at all periods after operation (Fig . \hyperref[fig_2]{6}.7). The BMC/TV values in ROI.5 (Lateral-Anterior), and ROI.6 (Lateral-Posterior) was significant higher in PS type than CR type at 3.18.21 months after operation (p<0.01, p<0.05. Fig. \hyperref[fig_4]{8}.9). The monoblock type consists of a porous tantalum ingrowth surface compression molded into it and two hexagonal porous tantalum pegs for initial stability. The modular type consists of a titanium alloy modular tray with a porous tantalum layer that also includes two hexagonal pegs and includes a central boss (small circular peg) in the central posterior of the tray that is used with a lock down screw \hyperref[b10]{[11]}. Early migration for porous tantalum monoblock tibial component was not continue but soon stabilized \hyperref[b11]{[12]}. Porous tantalum increased initial stability and accerated bone ingrowth and retented of bone stock through reduced stress shielding  {\ref [20]}. The flexibility of porous tantalum modular tibial component plate may produce radiolucencies at higher rate and it exhibited higher bone ingrowth than porous tantalum monoblock tibial component and implantation time was positively correlated with bone ingrowth for monoblock tibial components  {\ref [13.30]}.We evaluated the bone mineral content/total volume (BMC/TV) values between CR and PS type of porous tantalum modular tibial component up to twenty one months. In the current study, No manuscript were evaluated the BMC/TV values of CR and PS type by imaging the postoperative computed tomography. 
\section[{IV. Discussion}]{IV. Discussion}\par
The relationship between CR and PS type had the same factor for postoperative activites and accuracy position of total knee arthroplasty. There were siginificantly higher BMC/TV values for PS type than CR type in ROI.2.4.6 (Lateral, Lateral-Anterior, Lateral-Posterior) at three and eighteen , twenty one months after operation. We did not find a significant difference in the relative change in BMC/TV values in ROI.1.3.5 (Materal, Materal-Anterior, Materal-Posterior) between PS and CR type postoperatively. The presents study suggests that PS type associated with the post-cam mechanism was caused reactively higher BMC/TV values than CR type, associated with bone sclerotic change in medial tibial plateau for medial knee osteoarthritis at 3 months. We discussed that trabecular metal modular tibia (PS type) with midflextion instability was caused reactive cancellous stabilized and not occurred the influence of stress shieldings in lateral site under peg of tibial component than CR type, postoperative 18 months later. The present study had several limitations that should be considered. First, this study was prospective study, but patients could not be randomized. Additional research is required to determine the long-term benefits of porous tantalum modular tibial component for CR and PS type. Second, there are a relatively small size with short term follow up. Thid, computed tomography was not perfomed before operation, furthermore BMC TV values was not measured in view of radiation exposure. In present study we recongnized that trabecular metal modular tibia (PS type) was not affected the influence of stress shieldings.in spite of than CR type, post-operative 18 months later to 21 months. 
\section[{V. Conclusions}]{V. Conclusions}\par
This study revealed that trabecular metal modular tibia (PS type) with midflextion instability was caused reactive cancellous stabilized and not occurred the influence of stress shielding in lateral site under peg of tibial component than CR type postoperative 18 months later. 
\section[{VI. Acknowledgments}]{VI. Acknowledgments}\par
The authors gratefully acknowledge the valuable contributions of Eriko Yamaguchi, and Norihiko Kono M, D and Nobuhito Nango Ph,D in perfoming independent radiographic analysis.       \begin{figure}[htbp]
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\tabcellsep \multicolumn{2}{l}{cementless porous-coated anatomic knee knee}\tabcellsep \multicolumn{3}{l}{Orthop Scand 66; 513.}\\
\tabcellsep \multicolumn{2}{l}{prostheses. J Bone Joint Surg Br 77 (2); 236.}\tabcellsep \multicolumn{4}{l}{27. Pulido L, Abdel MP, Lewallen DG (2014). The Mark}\\
\tabcellsep \multicolumn{2}{l}{16. Laskin RS. The Genesis total knee prosthesis (2001)}\tabcellsep \multicolumn{2}{l}{Coventry}\tabcellsep Award:\tabcellsep Trabecular\tabcellsep Metal\tabcellsep Tibial\\
\tabcellsep \multicolumn{2}{l}{a 10-year follow up study. Clin Orthop Relat Res}\tabcellsep \multicolumn{4}{l}{Components Were Durable and Reliable in Primary}\\
\tabcellsep 388: 95-102.\tabcellsep \tabcellsep \multicolumn{4}{l}{Total Knee Arthroplasty: A Randomized Clinical}\\
\tabcellsep \multicolumn{2}{l}{17. Levine B, Della Valle CJ, Jacobs JJ (2006)}\tabcellsep \multicolumn{4}{l}{Trial. Clin Orthop Relat Res [Epub ahead of}\\
\tabcellsep \multicolumn{2}{l}{Applications of porous tantalum in total hip}\tabcellsep \multicolumn{4}{l}{print]?SYMPOSIUM?2014}\tabcellsep KNEE\tabcellsep SOCIETY\\
\tabcellsep \multicolumn{2}{l}{arthroplasty. J Am Acad Orthop Surg 14; 646.}\tabcellsep \multicolumn{3}{l}{PROCEEDING.}\\
\tabcellsep \multicolumn{2}{l}{18. Levine BR, Sporer S, Poggie RA, Della Valle CL,}\tabcellsep \multicolumn{4}{l}{28. Pavone V, Boettner F, Fickert S, Sculco TP (2001)}\\
\tabcellsep \multicolumn{2}{l}{Jacobs JJ (2006)Experimental and clinical}\tabcellsep \multicolumn{4}{l}{Total condylar knee arthroplasty:a long-term follow}\\
\tabcellsep \multicolumn{2}{l}{performance of porous tantalum in orthopaedic}\tabcellsep \multicolumn{4}{l}{up. Clin Orthop Relat Res 388:18-25.}\\
Year 2016\tabcellsep \multicolumn{2}{l}{surgery. Biomaterials 27: 4671-4681. 19. Levitz CL. Lotke PA, Karp JS (1995) Long-term changes in bone mineral density following tibia after total knee arthroplasty. Clin Orthop Relat Res 321:}\tabcellsep \multicolumn{4}{l}{29. Rodriguez JA,Bhende H,Renawat CS (2001)Total condylar knee replacement A 20-year followup study. Clin Orthop Relat Res 388:10:17 30. Stilling M, Madsen F (2011) Superior fixation of}\\
\tabcellsep 68.\tabcellsep \tabcellsep \multicolumn{4}{l}{pegged trabecular metal over screw-fixed pegged}\\
\tabcellsep \multicolumn{2}{l}{20. Li MG, Nilsson KG (2000) Changes in bone mineral}\tabcellsep \multicolumn{4}{l}{porous titanium fiber mesh: A randomized clinical}\\
Volume XVI Issue I Version I\tabcellsep \multicolumn{2}{l}{density at the proximal tibia after total knee arthroplasty. A 2-year follow-up of 28 knees using energy X-ray absorptiometry. J Orthop Res 18:40 21. Lombardi AV Jr, Berasi CC, Berend KR (2007) Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty 22 (4 suppl 1): 25-29. 22. Milchteim C, Unger AS (2011) Cementless fixation in high performance knee design. Tec Knee surg 10: 136-142. 23. Minoda Y, Kobayashi A, Ikebuchi M, Iwaki H, Inori F, Nakamura H (2013) Porous Tantalum tibial component prevents periprosthic loss of bone}\tabcellsep \multicolumn{4}{l}{RSA study on cementless tibialcomponents. Acta Orthop 82 (2): 177-186. 31. Wang CJ, Wang JW, Ko JY, Weng LH, Huang CC (2006) Three-year changes in bone mineral density around the knee after a six-month course of oral alendronate following total knee arthroplasty. A prospective randomized study. J Bone Joint Surg Am; 88; 267. 32. Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS (2003)The effect of alendronate on bone mineral density in the part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone}\\
D D D D )\tabcellsep \multicolumn{2}{l}{mineral density after total knee arthroplasty for five years-A matched cofort stydy. J Arthroplasty}\tabcellsep \multicolumn{4}{l}{Joint Surg Am 85; 2121. 33. Wegzyn J. Roux JP, Arlot ME, Boutroy S, Vilayphiou}\\
(\tabcellsep 28?1760-1764.\tabcellsep \tabcellsep \multicolumn{4}{l}{N, Guyen O, Delmas PD, Chapurlat R, Bouxsein L}\\
\tabcellsep \multicolumn{2}{l}{24. Niemelainen M, Skytta ET, Remes V (2014) Total}\tabcellsep \multicolumn{4}{l}{(2011) Determinants of Mechanical behavior of}\\
\tabcellsep \multicolumn{2}{l}{knee arthroplasty with an uncemented trabecular}\tabcellsep \multicolumn{4}{l}{human lumbar vertebrae after simulated mild}\\
\tabcellsep \multicolumn{2}{l}{metal tibial component: a registry-based analysis. J}\tabcellsep \multicolumn{4}{l}{fracture. J Bone Miner Res 26(4):739-746.}\\
\tabcellsep Arthroplasty 29(1):57.\tabcellsep \tabcellsep \multicolumn{4}{l}{34. Wilson DA, Richardson G, Hennigar AW, Dunbar MJ}\\
\tabcellsep \multicolumn{2}{l}{25. Pavone V, Boettner F, Fickert S, Sculco TP (2001)}\tabcellsep \multicolumn{4}{l}{(2012) Continued stabilization of trabecular metal}\\
\tabcellsep \multicolumn{2}{l}{Total condylar knee arthroplasty:a long-term follow}\tabcellsep tibial\tabcellsep \multicolumn{2}{l}{monoblock}\tabcellsep total\tabcellsep knee\tabcellsep arthroplasty\\
\tabcellsep \multicolumn{2}{l}{up. Clin Orthop Relat Res 388: 18-25}\tabcellsep \multicolumn{4}{l}{components at 5 years-measured with radiostereo-}\\
\tabcellsep \multicolumn{2}{l}{26. Petersen MM, Nielsen PT, Lauritzen JB, Lund B}\tabcellsep \multicolumn{4}{l}{metric analysis. Acta Orthop 83?36-40.}\\
\tabcellsep \multicolumn{2}{l}{(1995) Changes in bone mineral density of the}\tabcellsep \tabcellsep \tabcellsep \\
\tabcellsep \multicolumn{2}{l}{proximal tibia after uncemented total knee}\tabcellsep \tabcellsep \tabcellsep \\
\tabcellsep Subject preoperative data\tabcellsep CR type (n=23)\tabcellsep \multicolumn{2}{l}{PS type (n=23)}\tabcellsep \tabcellsep P value\\
\tabcellsep Age.mean ± SD years\tabcellsep 75.4 ± 5.2\tabcellsep \multicolumn{2}{l}{76.1 ± 4.8}\tabcellsep \tabcellsep 0.328\\
\tabcellsep Sex (women/men)\tabcellsep 22 / 1\tabcellsep \tabcellsep 22 / 1\tabcellsep \tabcellsep >0.999\\
\tabcellsep BMI,mean ± SD kg/m²\tabcellsep 26.3 ± 2.2\tabcellsep \multicolumn{2}{l}{25.2 ± 3.1}\tabcellsep \tabcellsep 0.253\\
\tabcellsep Knee Society Score Knee ± SD points Function ± SD points\tabcellsep 51.2 ± 9.6 44.2± 7.2\tabcellsep \multicolumn{3}{l}{48.6 ± 10.2 45.9 ± 8.4}\tabcellsep 0.321 0.289\\
\tabcellsep Femoro-tibial angle ± SD degree\tabcellsep 192.1 ± 9.2\tabcellsep \multicolumn{3}{l}{190.9 ± 8.1}\tabcellsep 0.271\end{longtable} \par
  {\small\itshape [Note: H]} 
\caption{\label{tab_1}Table 1 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{2} \par 
\begin{longtable}{P{0.4209369024856596\textwidth}P{0.1722753346080306\textwidth}P{0.1722753346080306\textwidth}P{0.08451242829827917\textwidth}}
Subject preoperative data\tabcellsep CR type (n=23)\tabcellsep PS type (n=23)\tabcellsep P value\\
Knee Society Score\tabcellsep \tabcellsep \tabcellsep \\
Symptoms(25)\tabcellsep 18.3 ± 4.3\tabcellsep 20.1 ± 4.4\tabcellsep 0.328\\
Patient satisfaction(40)\tabcellsep 23.3 ± 8.8\tabcellsep 24.1 ± 8.1\tabcellsep 0.420\\
Patient expectation(15)\tabcellsep 9.24 ± 3.2\tabcellsep 10.1 ± 2.8\tabcellsep 0.364\\
Functional activities(100)\tabcellsep 61.4 ± 14.2\tabcellsep 64.1 ± 16.9\tabcellsep 0.348\\
± SD points\tabcellsep \tabcellsep \tabcellsep \\
WOMAC Score\tabcellsep \tabcellsep \tabcellsep \\
Pain(20)\tabcellsep 12.3 ± 5.8\tabcellsep 11.6 ± 6.0\tabcellsep 0.410\\
Stiffness(8)\tabcellsep 6.71 ± 1.2\tabcellsep 5.89 ± 1.8\tabcellsep 0.483\\
Daily activities\tabcellsep 48.7± 14.2\tabcellsep 47.3± 13.9\tabcellsep 0.332\\
±SD points\tabcellsep \tabcellsep \tabcellsep \\
Hip-Knee-Ankle angle ±SD angle\tabcellsep 178.2 ± 2.3\tabcellsep 177.9 ± 1.7\tabcellsep 0.509\\
Condylar-twist\tabcellsep \tabcellsep \tabcellsep \\
angle(CTA)\tabcellsep 3.47 ± 1.9\tabcellsep 3.59 ± 1.1\tabcellsep 0.441\\
±SD angle\tabcellsep \tabcellsep \tabcellsep \end{longtable} \par
 
\caption{\label{tab_2}Table 2 :}\end{figure}
 			\footnote{© 2016 Global Journals Inc. (US)} 		 		\backmatter  			 
\subsection[{Conflict of interest}]{Conflict of interest}\par
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