The Journal of Arthroplasty Vol. 24 No.

7 2009

Three-dimensional Analysis of Computed Tomography–Based Navigation System for Total Knee Arthroplasty
The Accuracy of Computed Tomography–Based Navigation System
Hideki Mizu-uchi, MD, PhD,* Shuichi Matsuda, MD, PhD,* Hiromasa Miura, MD, PhD,* Hidehiko Higaki, PhD,y Ken Okazaki, MD, PhD,* and Yukihide Iwamoto, MD, PhD*

Abstract: We evaluated the postoperative alignment of 37 primary total knee arthroplasties performed using a computed tomography–based navigation system (Vector Vision Knee 1.5; Brain Lab, Germany) with a new 3-dimensional analysis. The mean coronal femoral angle was 89.0° ± 1.4° (85.5°-92.8°), and the coronal tibial component was 89.2° ± 1.0° (87.4°-91.6°). The hip-knee-ankle angle was observed to be 178.2° ± 1.5° (173.9°-181.8°). The external rotational alignment of the femoral component relative to the surgical epicondylar axis was −0.5° ± 1.7° (−3.2° to 3.4°). The results demonstrated that a computed tomography–based navigation system provided a reasonably satisfactory component alignment. The discrepancy between the 2-dimensional and 3-dimensional evaluations was 1.0° ± 0.9° (0.1°-3.4°). Threedimensional analysis is necessary to evaluate the accuracy of the navigation system. Keywords: total knee arthroplasty, navigation system, alignment, 3-dimensional analysis, CT. © 2009 Elsevier Inc. All rights reserved.

Optimal postoperative alignment of the lower extremity is important for achieving long-term survival after total knee arthroplasty (TKA). Any misalignment of the components could lead to various types of implant failures, such as aseptic loosening and instability, polyethylene wear, and patellar dislocation. Many surgeons use the alignment guide system because the center of the hip and
From the *Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka City, Japan; and yFaculty of Engineering, Kyushu Sangyo University, Fukuoka City, Japan. Submitted February 15, 2008; accepted July 9, 2008. No benefits of funds were received in support of the study. Reprint requests: Shuichi Matsuda, MD, PhD, Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka City 812-8582, Japan. © 2009 Elsevier Inc. All rights reserved. 0883-5403/08/2407-0016$36.00/0 doi:10.1016/j.arth.2008.07.007

ankle joints cannot be observed directly. However, it has been reported that these surgical techniques have an upper limit with respect to the accuracy of the postoperative alignment [1-9]. Navigation systems have been developed for TKAs to decrease the number of outliers required for achieving proper alignment. Many clinical and experimental studies of these navigation systems have demonstrated that the accuracy of implantation has improved following their use [10-22]. For both computed tomography (CT)-based navigation systems and image-free navigation systems, more than 90% of the operated knees achieved a postoperative mechanical axis alignment of the leg within 3° of neutral alignment [10-16,18-20,22]. Studies of navigation systems largely agree upon the necessity of obtaining accurate coronal postoperative alignments. However, in almost all these studies, analyses have been conducted using

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Brain LAB Inc. Germany) after patients were informed of the risk of radiation exposure and the duration required by the study. Informed consent was not obtained in the case of 10 patients (10 knees) because of the risk of radiation exposure from the postoperative CT scan. and a 100-mm section of the distal tibia were scanned with a slice thickness of 2 mm. the center of the knee joint. RA.8 ± 9. The bone threshold value was between 100 and 150 HU according to the patient's CT data. only 37 primary TKAs (69. and the size was chosen such that the component would not overhang the medial border of the tibia. One hundred thirty-six primary TKA were performed using the NexGen Legacy Posterior-Stabilized prosthesis (Zimmer. we adjusted the size of the femoral component to be as close as possible to the posterior condyles. Ind) by surgeons (S. Our hypothesis was that component alignment would be evaluated accurately by a new 3D analysis compared to conventional radiographic evaluation. the planned coronal alignment was set perpendicular to the mechanical axis of the tibia. For the tibial component. extra artifacts were deleted. Consequently. H.0° ± 1. After aligning the femoral component to the axis. and a CT-based navigation system would provide a satisfactory component alignment. Recently. Of these.0°-6.0-192. The reference clamp was fixed to the distal femur or the proximal tibia with a pin (2 pins.0 (61-87) 5 knees (4 patients)/ 32 knees (29 patients) 34 knees (30 patients)/ 3 knees (3 patients) 170. It is worth evaluating the postoperative alignment of the CT-based navigation system by a 3D method. Preoperative Demographic Data Mean age (y) Sex male/female Diagnosis OA/RA HKAA Mean follow-up time (y) 76.1 (157. instead of one. The present study established a new method for 3D reconstruction from postoperative CT images to accurately measure the alignment of the component relative to any designed plane. 1 patient (1 knee) died and 1 patient (1 knee) had an ipsilateral fracture of the femoral shaft due to falling down. For the femoral component. which was defined by a straight line between the center of the cutting line of the proximal tibia and the center of the ankle joint [8].M. and the bone surface was identified as clearly as possible.M and K. 3D analyses of image-free navigation systems have been reported by Chauhan et al [13] and Matziolis et al [16].0°] in flexion to the mechanical axis of the femur).9-4.5.8 (0. 7 October 2009 radiographs and/or CT scans without 3-dimensional (3D) evaluation.1 ± 6. it was difficult to accurately measure the angle of the position of the implants.1104 The Journal of Arthroplasty Vol.2° [1. 53 primary TKAs (39% of total TKAs) were performed in 47 patients using a CT-based navigation system (Vector Vision Knee 1. Therefore. . We determined the position of the tibial component to be 10 mm distal to the highest point of the tibial plateau. The planned sagittal alignment was set parallel to the anatomical axis of the distal femur to avoid notching of the femur due to its anterior bowing (average 3. the coronal alignment was set perpendicular to the mechanical axis of the femur. standard medial parapatellar exposure was used. Warsaw. were used from Materials and Methods Patients This study was approved by the institutional review board. a 100-mm section of the femoral head. and the center of the ankle joint after adjusting for the bone threshold and the window level and width. For surgical techniques.2 ± 0. Preoperative planning procedure and surgical techniques For CT scans. rheumatoid arthritis. These analyses comprised 2-dimensional (2D) evaluations that are affected by the positioning of the limb as well as the scanning direction. hence.9) OA indicates osteoarthritis.O) between November 2002 and May 2006. Heimstetten. The rotational alignment was adjusted to the surgical epicondylar axis (SEA) [23]. a 200-mm section whose midpoint was the knee joint. Table 1.8% of TKAs using the navigation system) performed for 33 patients have been included in this study. After the surgery. Thus far. The planned sagittal alignment was set parallel to the lateral anatomic tibial slope. few data have been published on such a 3D analysis of CT-based navigation systems. The demographic data for patients are presented in Table 1. which was a line connecting the sulcus of the medial epicondyle and the most prominent points of the lateral epicondyle of the femur.0) 2. 24 No. From these data. Four patients (4 knees) were not evaluated taking into consideration the possibility of over radiation because of the use of CT scans for examining deep vein thrombosis (3 patients) and headache (1 patient). we defined the center of the femoral head.

all the planes were checked by the verification tool of the navigation system. The coronal tibial component angle (CTA) was defined as the medial angle between the mechanical axis of the tibia and the horizontal axis of the tibial tray (Fig. which was shown on the navigation system. 2B). and the implants in the knee joint were extracted with adequate thresholds. The coronal plane of the femur was defined as corresponding to the mechanical axis of the femur and the SEA.0. We did not change preoperative planning.12. Dassault Systemes.Three-dimensional Analysis of CT-Based Navigation System for TKA  Mizu-uchi et al 1105 April 2005). the ankle joint. France) (Fig. Postoperative CT was performed in the same manner as the preoperative CT. the SEA. We determined the coordinate of the center of the femoral head and the ankle joint. Tokyo). The coronal plane of the tibia was defined as corresponding to the mechanical axis of the tibia and the line connecting the posterior edge of the tibial component.3. 1). Registration using surface matching of bones was achieved with a pointer to match the actual femur or tibia to the corresponding 3D CT images on the screen. The outer shape of the extracted images was modeled by using a software developed inhouse and then loaded onto a CAD software (CATIA Ver 5. . Evaluation of the postoperative alignment The postoperative knee statuses were assessed using The Knee Society scoring system. The coronal alignment of the femoral and tibial components had been planned such that the mechanical axis passed through the center of each com- Fig. the center of the femoral and tibial components. the distal anatomical axis of the femur. After resection. tibial. Three-dimensional model loaded onto a CAD software. the geometric centers of the femoral component pegs. We analyzed the CT scan data using computer software (Real INTAGE Ver. navigation. the femoral and tibial cutting blocks were positioned to match the preoperatively planned cutting plane. 1. By using the cutting block adapter. 2A).9 mm or better was achieved. A 100-mm section of the hip joint (around the femoral head) and a 100mm section of the ankle joint were scanned with a 2-mm slice thickness. Coronal alignment: The coronal femoral component angle (CFA) was defined as the medial angle between the mechanical axis of the femur and the horizontal axis of the 2 prosthetic condyles (Fig. and surgical procedure for this period. KGT Inc. and the posterior edge of the tibial component by using the 3D method. All femoral. A minimum of 8 points to a maximum of 20 points were registered until an accuracy of 1. 1. We defined the mechanical axes and planes by substituting the coordinates and analyzed the postoperative alignment of the femoral and tibial components from these images. The patella was resurfaced in all the patients. A 200-mm section of the knee joint was scanned with a 1-mm slice thickness. The hip joint. and patellar components were fixed with cement.

Sagittal alignment: The sagittal femoral component angle (SFA) was defined as the posterior angle between the mechanical axis of the femur and a line drawn perpendicular to the distal part of the femoral component (Fig.6 (−30 to 0) 116.0°-85.4 (90 to 140) . 7 October 2009 Fig.0°). 2D). Comparison Between the Preoperative and the Postoperative Clinical Data Preoperative Knee Society score Maximum extension angle Maximum flexion angle * Significantly different from preoperation.6 ± 12. 24 No.1106 The Journal of Arthroplasty Vol.3 (−15 to 0) * 115. The medial angle between the mechanical axis of the femur and that of the tibia was measured (hipknee-ankle angle [HKAA]).05). (A) The CFA.9 ± 16. (E) the RFA. The optimal RFA was 0°. Therefore. The sagittal plane of the femur was defined by a normal to a line connecting the geometric centers of the femoral component pegs.1° ± 0. The average optimal STA was 83. (C) the SFA. The optimal SFA was 90°—the difference between the mechanical axis and the anatomical axis in the sagittal plane. Table 2. 53.2° (84. A Mann Whitney U test was used to determine statistically significant differences in absolute value of the difference between the 2 methods using these parameters (significant: P b . the optimal CFA and CTA were 90° each.6 (85 to 145) Postoperative 95. ponent perpendicularly. (D) the STA. Rotational alignment: The rotational femoral component angle (RFA) was defined as the angle between the SEA and the posterior condylar line of the femoral component (+: External rotation in relation to the SEA.0 (81 to 100) * −2.7 ± 8.0°).2 (20 to 73) −9.0°-89. 2. The rotational plane of the femur was defined by the normal to the mechanical axis of the femur. The optimal STA was the angle between the mechanical axis and the lateral anatomic tibial slope in the sagittal plane. 2. Fig. 2C).2 ± 4. The sagittal tibial component angle (STA) was defined as the posterior angle between the mechanical axis of the tibia and a line on the tibial base plate (Fig. 3.0 ± 15. 2E). (B) the CTA. The sagittal plane of the tibia was defined by the normal to the line connecting the posterior edge of the tibial component. The average optimal SFA was 87. Results The clinical data of the preoperative and the postoperative data were presented in Table 2. and HKAA were also measured by the conventional radiograph method (full-length weight-bearing anteroposterior radiographs) and compared with the angle obtained using the 3D method. The CFA. CTA.0° ± 1.5° (82.5 ± 5. Measurement of the femoral and tibial component alignment.

The mean difference from the optimal STA was 1. It has been reported that an ideal positioning of the components can be achieved in 70% to 80% of the patients by using intramedullary or extramedullary alignment guides [5. including preoperative patient condition.7°-90.0-91. 5).8° (82.8) 89.7 ± 0. 4.5°). However.0001). Many clinical and experimental studies of these navigation systems have shown that the accuracy of implanted components has been improved [10-22].0°). 3 and 4).4) * 0. Navigation systems for TKA have been developed to achieve a greater accuracy than that obtained by the conventional method. delays in wound healing. The entry points for intramedullary alignment guides may change the alignment [4.2 ± 1.5 (85. 3.5. Wilcoxon test). A distribution of varus/valgus alignment of the tibial component in relation to the mechanical axis of the tibia. The CFA for 36 knees (97.8°).6]. 7). Fig. it is important to correctly align the femoral and tibial components and to balance the soft tissues adequately.5-92. further.0 ± 1.0 (87.7° (−3. the extramedullary alignment guide is easily affected by the condition of the ankle joint [2.0-93.6 (0. No patients had flexion contracture more than 20° or a flexion angle of less than 90°.6) Radiograph Method 178.2) 89.8 (173. the average RFA was −0. For rotational alignment. Statistically significant differences were detected in absolute value of the difference (P b . the RFA for 34 knees (91.9° to 3.0 ± 1.5 (173.6 (0. and surgical technique.8) * 0. which may be affected by many factors such as positioning Fig.7° (−3.5° ± 1.7].5° ± 1.Three-dimensional Analysis of CT-Based Navigation System for TKA  Mizu-uchi et al Table 3. However. its success is dependent on many factors.1-3. Statistically significant differences were detected in Knee Society score and the maximum extension angle (P b . and patellar problems. it is quite possible that the femoral and tibial components are malpositioned by the conventional method [1-9]. component design.9-181. implant materials.8 ± 0.9 (0.2%) was obtained within 3° from the optimal STA (Fig.4°). However.0) 1107 Absolute Value of Difference 1.4-91. A distribution of varus/valgus alignment of the femoral component in relation to the mechanical axis of the femur. There were no severe complications such as infection. most of these studies used 2D evaluations such as radiographs and/or CT scans (without 3D reconstruction).0°-87. For the sagittal alignment. The average STA was 84. moreover.9%) was obtained within 3° from the optimal RFA (Fig.0-2. . The mean differences from the optimal SFA was −0. For the coronal alignment.4° (−1.5 ± 1. 6).3° ± 1.6°).4 (85.2 ± 1. further. Table 3 showed the average angle and the mean absolute value of the difference between 3D evaluation and the conventional radiographic evaluation. Discussion Total knee arthroplasty has become one of the most successful orthopedic procedures.0001.7° to 2.9].1-2.5-181.2) * * Significantly different between 2 methods. the average SFA was 86. the SFA for 33 knees (89.5° ± 1.5 ± 1. With respect to surgical technique.4) 89.0001 and P = .3° ± 1. Comparison Between the 3D Method and the Conventional Radiograph Method Optimal HKAA (180) CFA (90) CTA (90) 3D Method 178.3 (87.3%) and the CTA for all the 37 knees (100%) were obtained within 3° from the optimal angle (Figs. and the STA for 33 knees (89.2%) was obtained within 3° from the optimal SFA (Fig.0 ± 0.5° (81.2° to 3.8) 89.

6. We established a new alignment analysis system by using the postoperative CT data. and the scanning direction of radiation. flexion angle of knees. The rotational plane of the femur was defined by the normal to the mechanical axis of the femur. In the case of the sagittal alignment. The postoperative alignments were measured on the basis of a defined plane that can be selected separately for the femoral and tibial components. It may be difficult to obtain genuine coronal planes for both the femoral and tibial components in full-length weight-bearing anteroposterior radiographs when there is a rotational mismatch between these components.19]. 5. We can conclude that for coronal alignment. This study is the first study to evaluate postoperative alignments using a 3D model reconstructed from CT data. and the rotation of the components. The sagittal planes were defined as a normal to the line connecting the geometric centers of the femoral component pegs and the line connecting the posterior edge of the tibial component. of radiation. the direction Fig. These planes can reduce the adverse affect of the varus-valgus position and rotational mismatch that occur frequently on lateral radiographs.4°. which may be a critical error in evaluating postoperative alignments. Positive values imply external rotation. however. A distribution of axial rotational alignment of the femoral component in relation to the SEA. This discrepancy may have been caused by a standing position. The coronal plane of the tibia was defined by the mechanical axis of the tibia and the line connecting the posterior edge of the tibial component.1108 The Journal of Arthroplasty Vol. It is important to measure the postoperative alignment 3-dimensionally for an exact evaluation. A distribution of the posterior slope of the tibial component in relation to the mechanical axis of the tibia.21] evaluated the rotational alignment only from CT slices that are strongly dependent on the scanning direction. the SFA and STA were achieved within 3° from the . The results of this study demonstrated that a CT-based navigation system provided a reasonably satisfactory component alignment as planned preoperatively. These planes can reduce the adverse affect of this discrepancy. 7. The mean difference in absolute value was within 1°. In the case of the coronal alignment. Fig. 24 No. A distribution of flexion of the femoral component in relation to the mechanical axis of the femur. Previous CT studies [13. the CFA and CTA were achieved within 3° from the optimal CFA and CTA in more than 95% of the procedures. the CT-based navigation system ensures the accuracy of positioning the components as reported by previous studies [18. The present study showed a discrepancy between 2D and 3D evaluations. of the legs. In this study. 7 October 2009 Fig. the maximum value was up to 3. a flexion-extension of the knee joint. the coronal plane of the femur was defined by the mechanical axis of the femur and the SEA.

Weiss U. et al. In summary. 7. MacDonald M.4°) for this difference was narrow. et al. Radiographic assessment of knee alignment after total knee arthroplasty.125:16. Laskin RS. et al. Shakespeare D. and spine surgery. Porcher R. J Bone Joint Surg Br 2004. Tingart M. Fukuoka city.9% of the procedures. 6.20 (7 Suppl 3):123. Computed tomography-based navigation for hip. ing in 673 press fit condylar posterior cruciatesacrificing total knee arthroplasties. Petersen TL. The accuracy of image-guided knee replacement based on computed tomography. It is possible to measure the postoperative alignment for TKA more accurately on the basis of the defining plane. 4. Kim SJ. 440:162. Intramedullary versus extramedullary tibial alignment systems in total knee arthroplasty. Can the epicondylar axis be defined accurately in total knee arthroplasty? Knee 2005. the discrepancy with conventional radiograph analysis was up to 3. Susman MH. Channer M. 14. but a large variability has also been reported [24.86:682.89:236. Instrumentation pitfalls: you just can't go on autopilot! J Arthroplasty 2003. Perlick L. Use of the Cusum technique for evaluation of a CT-based navigation system for total knee replacement. 2. Chauhan SK.425:180. Scott RG. J Arthroplasty 2001. Matsuda S. a surface-matching method with CT data has advantages over manual detection that is used with image-free navigation systems.Three-dimensional Analysis of CT-Based Navigation System for TKA  Mizu-uchi et al 1109 optimal SFA and STA in approximately 90% of the procedures. Amiot LP. Matsuda S. Breidahl W. Theoretically. Clark LD.16:635. Mizu-uchi H. Kohler S. Nicolai P. et al. Mihalko WM. J Bone Joint Surg Br 2004. Computer assisted navigation in total knee arthroplasty: improved coronal alignment. the range (−3. et al.25]. Intraoperative cutting errors in total knee arthroplasty. 3. this study is the first to evaluate postoperative alignments using a 3D model reconstructed directly from CT data. Acknowledgments The author thank Kurata K. The effect of ankle rotation on cutting error of the tibia in total knee arthroplasty. et al. A randomised.3:67. Tingart M. A comparison of computer-assisted surgery with the conventional technique. J Arthroplasty 1993. Hofmann A. PhD. Tingart M. Poulin F. et al. 13. Kinzel V. controversy still exists regarding the efficacy of a computer navigation system. J Arthroplasty 2003. 9. 8. 12. The variability of intramedullary alignment of the femoral component during total knee arthroplasty. Japan. Some studies [13. Bankes MJ. J Arthroplasty 2005. 17. Arch Orthop Trauma Surg 2005. et al. Our results thus demonstrated that good postoperative alignment was achieved as planned preoperatively with CTbased navigation systems. Computer navigation versus standard instrumentation for TKA: a singlesurgeon experience. Ledger M. et al. in the detection of the epicondylar axis. Bathis H. J Arthroplasty 2005.4°. Dennis DA. Hernandez J. Alignment in total knee arthroplasty. Engh GA. Clin Orthop Relat Res 2004.12:293.21] have reported an improved accuracy of rotational alignment with image-free navigation. 15. et al. et al. Consistency of implantation of a total knee arthroplasty with a non-image-based navigation system: a case-control study of 235 cases compared with 235 conventionally implanted prostheses. moreover. Clin Orthop Relat Res 2005. Bolognesi M. Clin Orthop Relat Res 2004. Miura H. Boyle J. Miura H. 8:43. Mahaluxmivala J. 10. et al. Perlick L. 19. The effect of surgeon experience on component position- 16. et al.18:56. 11.421:77. Matsuda S. J Arthroplasty 2005. Tibial shaft axis does not always serve as a correct coronal landmark in total knee arthroplasty for varus knees. J Bone Joint Surg Am 2006. Kyushu Sangyo University. Nizard RS. knee.75:464. Bathis H. et al. for the help in analyzing the data. Navigation in total-knee arthroplasty: CT-based implantation compared with the conventional technique. On the other hand. A prospective. few studies have so far shown the advantages of the CT-based navigation system. Perlick L. 20:832.18(3 Suppl 1):18. Faculty of Engineering. prospective trial. Mizu-uchi H. Nabeyama R. 18. Matziolis G.86:372. Computerassisted knee arthroplasty versus a conventional jigbased technique. References 1. J Bone Joint Surg Am 2007. In the case of femoral rotational alignment. randomized study of computer-assisted and conventional total knee arthroplasty. Clemens U. . Jenny JY. Our results demonstrated that for rotational alignment. Bathis H. the RFA was achieved within 3° of the optimal RFA in 91. Further. Acta Orthop Scand 2004. Three-dimensional evaluation of implant alignment and rotation.2° to 3. J Bone Joint Surg Br 2004. J Arthroplasty 1988. Miura H. 5.86:366. Ravaud P. 88:2632. This study confirms that improved postoperative rotational alignment of the femoral component can be achieved by using CT-based navigation systems. Krocker D.20:25. and Fukunaga T.

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