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. 2021 Feb 25;16(2):e0247412. doi: 10.1371/journal.pone.0247412

Biomechanical evaluation of high tibial osteotomy plate with internal support block using finite element analysis

Jesse Chieh-Szu Yang 1,2, Kuan-Yu Lin 3,4, Hsi-Hsien Lin 1,5, Oscar K Lee 2,6,7,*
Editor: Hans-Peter Simmen8
PMCID: PMC7906299  PMID: 33630875

Abstract

Background/Objective

High tibial osteotomy (HTO) is a common treatment for medial knee arthrosis. However, a high rate of complications associated with a plate and a significant loss of correction have been reported. Therefore, an internal support block (ISB) is designed to enhance the initial stability of the fixation device that is important for successful bone healing and maintenance of the correction angle of the osteotomy site. The purpose of this study was performed to examine if an internal support block combined with a plate reduces the stress on the plate and screw area.

Methods

Finite element models were reconstructed following three different implant combinations. Two loading conditions were applied to simulate standing and initial sit-to-stand postures. Data analysis was conducted to evaluate the axial displacement of the posteromedial tibial plateau, which represents the loss of the posteromedial tibial plateau in clinical observation. Moreover, the stresses on the bone plate and locking screws were evaluated.

Results

Compared to the TomoFix plate, the ISB reduced the axial displacement by 73% and 76% in standing and initial sit-to-stand loading conditions, respectively. The plate with an ISB reduced stress by 90% on the bone plate and by 73% on the locking screw during standing compared to the standalone TomoFix plate. During the initial sit-to-stand loading condition, the ISB reduced the stress by 93% and 77% on the bone plate and the locking screw, respectively.

Conclusion

The addition of the PEEK block showed a benefit for structural stability in the osteotomy site. However, further clinical trials are necessary to evaluate the clinical benefit of reduced implant stress and the internal support block on the healing of the medial bone tissue.

Introduction

Open-wedge high tibial osteotomy (OWHTO) is a surgical treatment for symptomatic malalignment in young and active patients [1, 2]. The initial stability of the fixation plate is critical for the successful maintenance of correction and the fusion of the osteotomy site. There are many different implants used for correcting varus deformity of the knee associated with medial compartment osteoarthritis [36]. However, a high rate of plate-related complications and a significant loss of correction have been reported [710]. Several biomechanical studies were performed to investigate the mechanical stability by finite element (FE) analyses [1114].

The goal of the current study was to compare the biomechanical features of 3 different fixation techniques in medial open-wedge HTO. The approaches included Medial High Tibial Plate (MHTP) fixation, MHTP with cannulated lag screw (CLS) fixation, and MHTP with internal support block (ISB) fixation.

Materials and methods

Generation of osteotomy finite element model

The intact left tibial model was obtained by the scan of the fourth generation Sawbones #3401 (SKU 3973, Pacific Research Laboratories, Inc., Vashon, WA, USA). The contours of the cortical and cancellous bone were used to generate the solid model in the SolidWorks CAD software (Solid Works Corp., Boston, U.S.A.). The tibial shaft is perpendicular to the ground in the sagittal plane, with a 3° varus tilting according to the general concept of the lower limb anatomy in the standing posture. Biplanar tibial tubercle preserving osteotomy was simulated for approximately 10 mm expansion at the medial osteotomy site (Fig 1) as the designated correction in OWHTO.

Fig 1. Orientation definition.

Fig 1

(a) Orientation definition; (b) The coronal view of the solid model representing a biplanar high tibial osteotomy; (c) The sagittal view of the solid model representing a biplanar high tibial osteotomy.

Generation of osteotomy finite element model with three different implant combination

This study employed an automatic mesh generation algorithm with Simulation Version 2010 software (SolidWorks Corporation, Concord, MA, USA). The following three different implant combinations were inserted into the osteotomy model (Fig 2): (A) the conventional fixator, the TomoFix (Depuy Synthes, PA, USA) was placed at the anteroposterior region of the osteotomy model, denoted as "MHTP". A total of 8 locking screws (diameter, 5 mm) were fixed in all the locking holes on the plate; (B) a cannulated lag screw (Diameter of 8mm; Stryker, MI, USA) was applied in the MHTP model to simulate the technique of opposite screw insertion, denoted as "CLS". The opposite screw was inserted from the lateral cortex to the region beneath the medial-lateral plateau, in the orientation of approximately 50 degrees oblique in the coronal plane and 38.5 degrees oblique in the transverse plane; (C) a PEEK internal block was applied in the MHTP model to determine how an internal block contributes to the stability of osteotomy model, denoted as "ISB".

Fig 2. The osteotomy model.

Fig 2

The osteotomy model with three different implant combinations: (a) The TomoFix (MHTP); (b) The TomoFix with an 8 mm cannulated lag screw (CLS); (c) the TomoFix with a PEEK internal support block (ISB).

To simplify the finite element analysis, the lower half of the surrogate bones and the threads on the screws (including the locking screws and the cannulated lag screw) were all removed. The isotropic linear homogeneous elastic material properties were assigned to different parts of the model according to the previous literature [15] as shown in Table 1. A Young’s modulus of 17,000 and 300 MPa, and Poisson’s ratio of 0.36 and 0.3 were defined for the cortical bone and the cancellous bone, respectively. The plate, locking screw, and cannulated lag screw were all defined as titanium alloy with homogeneous and linear elastic properties, and the values of Young’s modulus and Poisson’s ratio were 113 GPa and 0.33, respectively. The internal block was defined as PEEK with Young’s modulus of 3.5 GPa and Poisson’s ratio of 0.3 [16].

Table 1. Material properties specified in the finite element models.

Material Elastic modulus (MPa) Poisson’s ratio
Cancellous bone 17000 0.36
Cortical bone 300 0.30
Titanium Alloy 113000 0.33
PEEK 3.5 0.30

Loading and boundary conditions

Two different loading conditions were applied in all three models to simulate the loads in the standing posture and at the initial stage of the sit-to-stand movement. For the standing posture, a 600 N axial compressive load was applied on the full tibial plateau and the loading ratio of the medial and lateral plateau was 60 and 40%, respectively [15] (Fig 3). An additional 600-N axial compressive load was applied on the posterior half of the tibial plateau only to simulate the load at the initial stage of the sit-to-stand movement [17]. For the osteotomy model with the cannulated lag screw, a pretension force of 100 N was applied on the 8.0-mm lag screws. The screw-plate and block-bone interface was assumed to be bonded without separating and sliding. Fully constrained was applied to the distal end of the tibial osteotomy model (Fig 3).

Fig 3. Illustrations showing the ratio of the axial loads.

Fig 3

Illustrations showing the ratio of the axial loads on the quadrants of the proximal tibia.

Data analysis

Data analysis was conducted to evaluate the effect of the opposite screws and internal block on the stabilization. The axial displacement of the posteromedial tibial plateau was analyzed and compared with the osteotomy model. Each maximum Von Mises stress at the plate and locking screws was calculated in two loading conditions for three different models.

Results

Differences in axial displacement posteromedial tibial plateau

Relative loss of posterior reduction after loading was found at the posteromedial region of the tibial plateau. The values of the axial displacement were normalized in the MHTP model (with Tomofix) for the two different loading conditions. Compared with the values of the MHTP model in standing and sit-to-stand loads, the axial displacement of the tibial plateau after the lag cannulated screw insertion decreased by 11% and 18%, respectively (Fig 4). The axial displacement of the tibial plateau after the internal block insertion decreased by 73% and 76%, respectively (Fig 4).

Fig 4. The percentages of loss of posteromedial reduction.

Fig 4

The percentages of loss of posteromedial reduction on the tibial plateau, normalized by the magnitude in the osteotomy model.

Stresses on the bone plate

The percentile differences of the maximum von Mises stress on the bone plate were calculated as (σCLS-σMHTP)/σMHTP or (σISB-σMHTP)/σMHTP in two different loading conditions. The maximum stress of the bone plate after the lag cannulated screw insertion decreased by 20% and 26% in standing and sit-to-stand, respectively (Fig 5A). The maximum stress of the bone plate after the internal block insertion decreased by 90% and 93% in standing and sit-to-stand, respectively (Fig 5B).

Fig 5. The stress patterns and values on the bone plate.

Fig 5

The stress patterns and values on the bone plate in three models in the standing and sit-to-stand loading conditions.

Stress on locking screws

The percentile differences of the maximum von Mises stress on the locking screws were calculated as (σCLS-σMHTP)/σMHTP or (σISB-σMHTP)/σMHTP in two different loading conditions. The maximum stress of the locking screws after the lag cannulated screw insertion decreased by 27% and 37% in standing and sit-to-stand, respectively (Fig 6A). The maximum stress of the locking screws after the internal block insertion decreased by 73% and 77% in standing and sit-to-stand, respectively (Fig 6B).

Fig 6. The stress patterns and values on the locking screws.

Fig 6

The stress patterns and values on the locking screws in three models in the standing and sit-to-stand loading conditions.

Discussion

The knee joint is one of the largest and most heavily loaded joints of the human body during daily activities [18]. The fixation device of HTO surgery is used to stabilize the opening and enhance bone union. This study used finite element analysis to evaluate the effects of the construct stress of the locking screw, plate, and wedge micromotion. For the ISB model, the screw, plate, and bone stresses of the TomoFix plate were respectively 73%, 90%, and 79% less than those of the MHTP model (Fig 7).

Fig 7. Percentages of loss of stress.

Fig 7

Percentages of loss of stress on the screw, plate, and bone, respectively.

Previous FE and biomechanical studies on the medial fixation device demonstrated good stability [19, 20]. The purpose of this study was to compare a TomoFix plate, a TomoFix plate with a lag cannulated screw, as well as a PEEK internal block inserted to support the medial opening gap, by using computational simulations. Our results showed that the stress on the implants in the CLS was lower than that in the MHTP. This observation was also reported in an FE analysis in a previous study [21]. The study demonstrated that a TomoFix with a lag cannulated screw provided a better anchorage than the plate alone, thereby displacing the stresses transmitted by body weight. The PEEK block reduced the downward displacement of the proximal tibia and screw. Therefore, the plate stress is reduced to prevent implant broken and to enhance the stability of the tibia after high tibial osteotomy.

Several limitations of the study should be further considered. Firstly, the material properties of all components in the current FE model were assigned as homogenous, isotropic, and linear elastic. This study focused on the effect of different fixation methods of HTO. The influence of simplified material properties of bony structure on simulated results can be comparatively minor. In addition, only a single Sawbone model has been considered in this study. The different geometries of real tibial bone structures would possibly be influential to biomechanical behavior after HTO. Secondly, the findings could be different in a real clinical situation even though simulated conditions reflecting clinical and surgical situations were assessed in all cases. Especially, it is difficult to define the contact conditions of a real situation by using the friction coefficient of general contact conditions. Moreover, only the standing and sit to stand loading conditions were considered. The effect of fixation approaches in walking was not considered. Lastly, The theoretical advantage in our simulated study is difficult to predict directly whether surgical complications can be avoided in the actual situation.

Conclusion

Compared to conventional fixation instrumentation, the plate/screw stress was redistributed and reduced with the combination of a PEEK internal block. However, further investigation on in vitro biomechanical tests and clinical trials will be necessary to determine whether this internal PEEK block can reduce the fracture risk on the implant and enhance the bone fusion rate in the osteotomy site.

Data Availability

All relevant data are within the manuscript.

Funding Statement

The authors received no specific funding for this work.

References

  • 1.Amis AA. Biomechanics of high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013;21(1):197–205. 10.1007/s00167-012-2122-3 [DOI] [PubMed] [Google Scholar]
  • 2.Pape D, Seil R, Adam F, Kohn D, Lobenhoffer P. Bildgebung und präoperative Planung der Tibiakopfosteotomie. Orthopäde. 2004,33:122–34. 10.1007/s00132-003-0585-0 [DOI] [PubMed] [Google Scholar]
  • 3.Pape D, Lorbach O, Schmitz C, Busch LC, Van Giffen N, Seil R, et al. Effect of a biplanar osteotomy on primary stability following high tibial osteotomy: a biomechanical cadaver study. Knee Surg Sports Traumatol Arthrosc. 2010;18(2):204–11. 10.1007/s00167-009-0929-3 [DOI] [PubMed] [Google Scholar]
  • 4.Pape D, Kohn D, van Giffen N, Hoffmann A, Seil R, Lorbach O. Differences in fixation stability between spacer plate and plate fixator following high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013;21(1):82–9. 10.1007/s00167-011-1693-8 [DOI] [PubMed] [Google Scholar]
  • 5.Watanabe K, Kamiya T, Suzuki D, Otsubo H, Teramoto A, Suzuki T, et al. Biomechanical stability of open-wedge high tibial osteotomy: comparison of two locking plates. Open J Orthop. 2014;4(10):257–61. [Google Scholar]
  • 6.Burchard R, Katerla D, Hammer M, Pahlkotter A, Soost C, Dietrich G, et al. Intramedullary nailing in opening wedge high tibial osteotomy-in vitro test for validation of a method of fixation. Int Orthop. 2018;42(8):1835–43. 10.1007/s00264-018-3790-5 [DOI] [PubMed] [Google Scholar]
  • 7.Cotic M, Vogt S, Hinterwimmer S, Feucht MJ, Slotta-Hus-penina J, Schuster T, et al. A matched-pair comparison of two different locking plates for valgus-producing medial open-wedge high tibial osteotomy: peek-carbon composite plate versus titanium plate. Knee Surg Sports Traumatol Arthrosc. 2014,23(7):2032–40. 10.1007/s00167-014-2914-8 [DOI] [PubMed] [Google Scholar]
  • 8.Nelissen EM, van Langelaan EJ, Nelissen RG. Stability of medial opening wedge high tibial osteotomy: a failure analysis. Int Orthop. 2010,34:217–23. 10.1007/s00264-009-0723-3 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 9.Schroter S, Gonser CE, Konstantinidis L, Helwig P, Albrecht D. High complication rate after biplanar open wedge high tibial osteotomy stabilized with a new spacer plate (position HTO plate) without bone substitute. Arthroscopy. 2011,27:644–52. 10.1016/j.arthro.2011.01.008 [DOI] [PubMed] [Google Scholar]
  • 10.Valkering KP, van den Bekerom MP, Kappelhoff FM, Albers GH. Complications after tomofix medial opening wedge high tibial osteotomy. J Knee Surg. 2009,22:218–25. 10.1055/s-0030-1247752 [DOI] [PubMed] [Google Scholar]
  • 11.Izaham R, Kadir MR, Rashid AH, Hossain G, Kamarul T. Finite element analysis of Puddu and Tomofix plate fixation for open wedge high tibial osteotomy. Injury. 2012,43:898–902. 10.1016/j.injury.2011.12.006 [DOI] [PubMed] [Google Scholar]
  • 12.Luo CA, Hua SY, Lin SC, Chen CM, Tseng CS. Stress and stability comparison between different systems for high tibial osteotomies. BMC Musculoskelet Disord. 2013,14:110. 10.1186/1471-2474-14-110 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13.Pauchard Y, Ivanov TG, McErlain DD, Milner JS, Giffin JR, Birmingham TB, et al. Assessing the local mechanical environment in medial opening wedge high Tibial osteotomy using finite element analysis. J Biomech Eng. 2015,137(3):031005. 10.1115/1.4028966 [DOI] [PubMed] [Google Scholar]
  • 14.Luo CA, Hua SY, Lin SC, Chen CM, Tseng CS. Placement-induced effects on high tibial osteotomized construct—biomechanical tests and finite-element analyses. BMC Musculoskelet Disord. 2015,16:235. 10.1186/s12891-015-0630-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Jang YW, Lim D, Seo H, Lee MC, Lee OS, Lee YS. Role of an anatomically contoured plate and metal block for balanced stability between the implant and lateral hinge in open-wedge high-tibial osteotomy. Arch Orthop Trauma Surg. 2018,138(7):911–20. 10.1007/s00402-018-2918-9 [DOI] [PubMed] [Google Scholar]
  • 16.Vadapalli S, Sairyo K, Goel VK, Robon M, Biyani A, Khandha A, et al. Biomechanical rationale for using polyetheretherketone (PEEK) spacers for lumbar interbody fusion-a finite element study. Spine. 2006,31:E992–8. 10.1097/01.brs.0000250177.84168.ba [DOI] [PubMed] [Google Scholar]
  • 17.Yang JCS, Chen CF, Lee OK. Benefits of opposite screw insertion technique in medial open-wedge high tibial osteotomy: A virtual biomechanical study. Journal of Orthopaedic Translation. 2020,20:31–36. 10.1016/j.jot.2019.06.004 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18.Potočnik B, Zazula D, Cigale B, Heric D, Cibula E, Tomažič T. A patient-specific knee joint computer model using MRI data and ‘in-vivo’ compressive load from the optical force measuring system. Journal of Computing and Information Technology–CIT. 2008,16:209–22. [Google Scholar]
  • 19.Golovakhsmall a CML, Orljanski W, Benedetto KP, Panchenko S, Buchler P, Henle P, et al. Comparison of theoretical fixation stability of three devices employed in medial opening wedge high tibial osteotomy: a finite element analysis. BMC Musculoskelet Disord. 2014,15:230. 10.1186/1471-2474-15-230 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20.Luo CA, Hwa SY, Lin SC, Chen CM, Tseng CS. Placement induced effects on high tibial osteotomized construct—biomechanical tests and finite-element analyses. BMC Musculoskelet Disord. 2015,16:235. 10.1186/s12891-015-0630-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 21.Yang CS, Chen CF, Lee OK. Benefits of opposite screw insertion technique in medial open-wedge high tibial osteotomy: A virtual biomechanical study. Journal of Orthopaedic Translation. 2020,20:31–6. 10.1016/j.jot.2019.06.004 [DOI] [PMC free article] [PubMed] [Google Scholar]

Decision Letter 0

Hans-Peter Simmen

23 Dec 2020

PONE-D-20-23602

Biomechanical Evaluation of High Tibial Osteotomy Plate with Internal Support Block Using Finite Element Analysis

PLOS ONE

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Reviewer #1: The manuscript evaluates the effects of an internal support block on the stresses on bone plate and locking screws. This manuscript covers an interesting topic and is worth considering. However, there are some important issues about the details of the research. Critiques of the revised manuscript and suggestions for the authors are given below:

1. (Lane 69) The geometric information of the left tibial sawbone is not clear. Is this model developed based on medical images? If so, basic information about the patient/volunteer is needed, such as, age, weight, injury history, etc. If this model is previously published, please add a reference, or clarify what is #3401; Sawbones, WA, United States.

2. (Lane 96) Please justify that isotropic linear homogeneous elastic material model is appropriate. It might be more accurate to model the bone as elastic-plastic material according to other studies.

For example:

Tippanagoudar, Naveen, and A. Krishna. "Finite element analysis of tibia bone." Int J Eng Sci Comput 8.12 (2018): 19534-7.

Untaroiu, Costin D., Neng Yue, and Jaeho Shin. "A finite element model of the lower limb for simulating automotive impacts." Annals of biomedical engineering 41.3 (2013): 513-526.

3. (Lane 111) Please provide a reference for the initial load of sit-to-stand movement (600N axial load).

4. (Lane 120) It is unclear why the displacement of the posteromedial tibial plateau, stresses of the bone plate and locking stews were selected to be compared in this study. What are the effects of these parameters on clinical treatments?

5. (Lane 126-149) The results were only compared relatively (only percentile differences were shown). Please also show the absolute values. For example, the maximum stress of the bone plate. This data will provide more confidence to this study.

6. (Figure 1) It will be also helpful to show the size of the bone in figure 1, not only the size of the opening wedge.

Reviewer #2: In this evaluation the authors have compared three different types of fixation after high tibial osteotomy (HTO) by a finite element model.

The evaluation is purely based on a computed simulation. In their results the authors demonstrate that with an internal support block that is placed into the osteotomy the axial displacement is reduced by 18% in standing and 100% in a sit-to-stand loading condition.

Critical comment

It is difficult to say whether finite element models are able to simulate complex biomechanical conditions like weight bearing and loading after HTO.

The authors have compared three different models of high tibial osteotomy. Since the conclusions of the study are based purely on the simulation of loading the HTO, the authors have to demonstrate more in detail the reliability of their calculations.

The first model is an open osteotomy without any additional implants but plate and screws and is comparable to date standard procedure.

The second construct is an osteotomy with an additional lag screw that is placed with a 90° angulation to the osteotomy. The role of the lag screw is difficult to understand. This lag screw augments the compression forces on the osteotomy. As a lag screw this screw does not give any additional stability to the construct.

A) Therefore the authors have to explain why they have analysed this construct.

In their third model they have virtually placed an internal block of PEEK in the osteotomy to augment the stability with respect to compression forces. For the mechanical stability it makes a difference if the block is placed exactly on the cortex of the medial tibia or in the cancellous bone area.

B) It should be explained where the block is placed exactly in the tibial area.

A last question is whether a simple compression by standing or by a sit-to-stand procedure is simulated or if repeated loadings have been calculated. In order to simulate the real stress on such a construct repeated loading has to be taken into consideration. Only by such a biomechanical simulation it can be excluded that the internal block does not lose function when it is continuously pressed into the bone.

C) Is the model calculated with continuous loading and unloading?

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Reviewer #1: No

Reviewer #2: No

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PLoS One. 2021 Feb 25;16(2):e0247412. doi: 10.1371/journal.pone.0247412.r002

Author response to Decision Letter 0


4 Feb 2021

Replies to reviewer #1

We would like to thank the reviewer for the great assistance in revising our manuscript entitled “Biomechanical evaluation of high tibial osteotomy plate with internal support block using finite element analysis” (PONE-D-20-23602). The comments were very helpful for making this manuscript more presentable. We have reviewed the comments carefully and have made corrections accordingly. All the newly added texts are underlined and marked in blue color in the revised manuscript. We hope the reviewer will find the revision satisfactory. Below, we reply to the reviewer's comments point-by-point.

1. (Lane 69) The geometric information of the left tibial sawbone is not clear. Is this model developed based on medical images? If so, basic information about the patient/volunteer is needed, such as, age, weight, injury history, etc. If this model is previously published, please add a reference, or clarify what is #3401; Sawbones, WA, United States.

Reply: Thank you for your comment. Sawbones #3401 (Pacific Research Laboratories, Inc., Vashon, WA, USA) is the fourth generation composite tibia designed to mimic the human tibia and usually used in the biomechanical test. The 3D CAD model was created from a scanned composite tibia obtained by Pacific Research Laboratories. A more detailed description of the 3D model of Sawbones #3401 has been added in the revised manuscript (Lane 69).

2. (Lane 96) Please justify that isotropic linear homogeneous elastic material model is appropriate. It might be more accurate to model the bone as elastic-plastic material according to other studies. For example: Tippanagoudar, Naveen, and A. Krishna. “Finite element analysis of tibia bone.” Int J Eng Sci Comput 8.12 (2018): 19534-7. Untaroiu, Costin D., Neng Yue, and Jaeho Shin. "A finite element model of the lower limb for simulating automotive impacts." Annals of biomedical engineering 41.3 (2013): 513-526.

Reply: Thank you for your comment. We agree with the reviewer that it might be more accurate to model the bone as elastic-plastic material. Therefore, the additional limitations described above were added in the revised manuscript (Lane 196).

3. (Lane 111) Please provide a reference for the initial load of sit-to-stand movement (600N axial load).

Reply: Thank you for your comment. The referenced literature for the loading condition of the sit-to-stand movement was added in the revised manuscript (Lane 267, Reference #17).

4. (Lane 120) It is unclear why the displacement of the posteromedial tibial plateau, stresses of the bone plate and locking screws were selected to be compared in this study. What are the effects of these parameters on clinical treatments?

Reply: The change in height at the posteromedial tibial plateau was the index of construct stability. Maximal von Mises stresses at screws and plates were the indices of implant and bone failure. The above three indices were chosen because stable correction, early full weight-bearing, and bone union after medial open-wedge HTO are essential to achieve the goal of enhanced recovery after surgery.

5. (Lane 126-149) The results were only compared relatively (only percentile differences were shown). Please also show the absolute values. For example, the maximum stress of the bone plate. This data will provide more confidence to this study.

Reply: Thank you for your comment. The absolute values have been added to Figure 4 to Figure 6. Additionally, some numbers of the percentile differences of results have been corrected in the revised manuscript.

6. (Figure 1) It will be also helpful to show the size of the bone in figure 1, not only the size of the opening wedge.

Reply: Thank you for your comment. More information about the tibia size has been added to Figure 1.

Replies to reviewer #2

We would like to thank the reviewer for the great assistance in revising our manuscript entitled “Biomechanical evaluation of high tibial osteotomy plate with internal support block using finite element analysis” (PONE-D-20-23602). The comments were very helpful for making this manuscript more presentable. We have reviewed the comments carefully and have made corrections accordingly. All the newly added texts are underlined and marked in blue color in the revised manuscript. We hope the reviewer will find the revision satisfactory. Below, we reply to the reviewer's comments point-by-point.

1. It is difficult to say whether finite element models are able to simulate complex biomechanical conditions like weight bearing and loading after HTO.

Reply: Thank you for your comment. The additional limitation was added in the revised manuscript (Lane 202).

2. The authors have compared three different models of high tibial osteotomy. Since the conclusions of the study are based purely on the simulation of loading the HTO, the authors have to demonstrate more in detail the reliability of their calculations.

Reply: Thank you for your comment. The following figures show the validation of the current study in terms of result convergence and construct stiffness. The construct stiffness of MHTP converges to 1644 N/ mm until the element number reached about 262, 582 (left of the figure below). For the convergent stiffness, the numerical was within the range of the previous experimental results (right of the figure below). This indicates that good agreement is achieved, and the finite-element model is validated for further analyses.

3. The first model is an open osteotomy without any additional implants but plate and screws and is comparable to date standard procedure. The second construct is an osteotomy with an additional lag screw that is placed with a 90° angulation to the osteotomy. The role of the lag screw is difficult to understand. This lag screw augments the compression forces on the osteotomy. As a lag screw this screw does not give any additional stability to the construct. (A) Therefore the authors have to explain why they have analysed this construct.

Reply: In the previous FEA [Yang et al., JOT, 2020] and sawbones experimental studies [Yang et al., PLOS ONE, 2020], Yang et al. reported that structural stability and durability can be improved if followed by supplemental screw insertion in medial open wedge HTO. Therefore, the present study evaluated the potential advantage of block insertion compared to the opposite screw insertion in medial open-wedge HTO.

4. In their third model they have virtually placed an internal block of PEEK in the osteotomy to augment the stability with respect to compression forces. For the mechanical stability it makes a difference if the block is placed exactly on the cortex of the medial tibia or in the cancellous bone area. (B) It should be explained where the block is placed exactly in the tibial area.

Reply: The internal spacer was designed with a banana-shaped and placed posterior medial region of the medial open wedge side as shown in the following figure.

5. A last question is whether a simple compression by standing or by a sit-to-stand procedure is simulated or if repeated loadings have been calculated. In order to simulate the real stress on such a construct repeated loading has to be taken into consideration. Only by such a biomechanical simulation it can be excluded that the internal block does not lose function when it is continuously pressed into the bone. (C) Is the model calculated with continuous loading and unloading?

Reply: Only the standing and sit to stand loading conditions were considered in this study. Therefore, continuous loading and unloading conditions were not applied in our FE analysis. Based on the observation in the current study, further in vitro biomechanical tests and clinical trials are planned for clarification and verification in reality.

Attachment

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Decision Letter 1

Hans-Peter Simmen

8 Feb 2021

Biomechanical Evaluation of High Tibial Osteotomy Plate with Internal Support Block Using Finite Element Analysis

PONE-D-20-23602R1

Dear Dr. Lee,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Hans-Peter Simmen, M.D., Professor of Surgery

Academic Editor

PLOS ONE

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Reviewers' comments:

Acceptance letter

Hans-Peter Simmen

15 Feb 2021

PONE-D-20-23602R1

Biomechanical Evaluation of High Tibial Osteotomy Plate with Internal Support Block Using Finite Element Analysis

Dear Dr. Lee:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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Kind regards,

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on behalf of

Dr. Hans-Peter Simmen

Academic Editor

PLOS ONE

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