The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 89, Issue 2

Scientific Articles | February 01, 2007

Improving Tibial Component Coronal Alignment During Total Knee Arthroplasty with Use of a Tibial Planing Device

Shantanu Patil, MD¹; Darryl D. D'Lima, MD¹; James M. Fait, MD¹; Clifford W. ColwellJr., MD¹

¹ Shiley Center for Orthopaedic Research and Education at Scripps Clinic, 11025 North Torrey Pines Road, Suite 140, La Jolla, CA 92037. E-mail address for C.W. Colwell: colwell@scripps.edu

View Disclosures and Other Information

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Investigation performed at the Shiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla, California

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2007 Feb 01;89(2):381-387. doi: 10.2106/JBJS.F.00204

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Abstract

Background: The outcomes of knee arthroplasty have been shown to be affected by component alignment. Intramedullary and extramedullary alignment instrumentation are fairly effective for achieving the desired mean tibial component coronal alignment. However, there are outliers representing >3° of varus or valgus alignment with respect to the anatomic tibial shaft axis. We measured the efficacy of a custom tibial planing device for reducing the outliers in tibial alignment.

Methods: We designed a tibial planing tool in an effort to improve tibial alignment. In one cohort (100 knees), we used traditional intramedullary alignment instrumentation to make the tibial bone cut. In a second cohort (120 knees), we used intramedullary alignment instrumentation to make the cut and also used a custom tool to check the cut and to correct an inexact cut. Tibial tray alignment relative to the long axis of the tibial shaft was measured in the coronal and sagittal planes on postoperative radiographs. The target coronal alignment was 90° with respect to the tibial shaft axis (with <90° denoting varus alignment). A total of 100 anteroposterior radiographs and sixty-five lateral radiographs were analyzed for the group that was treated with traditional instrumentation alone, and a total of 120 anteroposterior radiographs and fifty-five lateral radiographs were analyzed for the group that was treated with use of the custom tibial planing device.

Results: The mean coronal alignment of the tibial component was 89.5° ± 2.1° in the group that was treated with traditional instrumentation alone and 89.6° ± 1.4° in the group that was treated with use of the custom planing device. Although the mean coronal alignment was not significantly different, the number of outliers was substantially reduced when the custom planing device was used. All 120 components that had been aligned with use of the custom planing device were within 3° of the target coronal alignment, compared with only eighty-seven of the 100 components that had been implanted with use of traditional intramedullary alignment alone (p = 0.05).

Conclusions: The use of a simple, inexpensive tibial planing device reduced the number of outliers due to tibial tray malalignment. Tibial varus has been associated with a higher risk of failure. Improving the accuracy of tibial component alignment may reduce the potential for poor clinical outcomes.

Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Over the past few decades, the surgical instrumentation and implant designs used for total knee arthroplasty have undergone a series of improvements. The clinical outcome of total knee arthroplasty depends on many factors, including patient selection, prosthetic design, softtissue balancing, alignment of the lower limb, and restoration of the joint line. Malalignment of the prosthesis can compromise the clinical outcome^1,2. Malalignment of the prosthesis may lead to deleterious stresses on implanted components and to increased wear rates^3,4, which are reflected in poor short-term and long-term results and in higher failure rates^1,5-7.

Surgical preparation of the proximal part of the tibia is typically done with use of an oscillating saw guided by a cutting block, which is in turn positioned with the help of intramedullary or extramedullary alignment instruments. Errors in surgical preparation for the bone cuts can occur as deviation of the surface from the desired alignment or as deviation from a flat plane. A maximum roughness of cut surfaces (measured as the distance of individual points on the surface from the midplane of the cut surface) of as much as 1.71 mm has been reported⁸. A mean deviation of 0.5° (maximum, 1.8°) in the frontal plane and of 1° (maximum, 4.1°) in the coronal plane have been recorded between the position of the cutting block and the resulting bone cut⁹. The quality of bone can play an important role in the accuracy of cutting. Areas of sclerotic bone and the relatively harder posterior cortex can flex the blade, resulting in a curved cut surface. Furthermore, a bone cut that more closely approximates the undersurface of the tray may have the potential for better fixation and therefore may enhance bone ingrowth in patients who are managed with cementless components. This advantage may have less value in those who are managed with cemented components.

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Fig. 1: The components of the tibial planing device, including the flat plate for checking the proximal tibial bone cut (A), the intramedullary rod (B), the rasp for removing local surface irregularities (C), the custom planer for correcting the angle of a misaligned tibial cut (D), and the tamp to hold the planer against the cut surface of the bone (E).

To address concerns regarding deviations in alignment and the "flatness" of the tibial cut, we designed a simple tibial planing tool. This device was developed in an effort to improve cut alignment and flatness intraoperatively. Therefore, the purpose of the present study was to evaluate the efficacy of this device in achieving these goals.

Materials and Methods

Materials and Methods | Results | Discussion | References

After institutional review board approval had been obtained, we evaluated two methods for guiding the tibial bone cut and aligning the tibial component in a series of total knee arthroplasties that were performed by one surgeon (C.W.C. Jr.) from 1983 to 2001. From 1988 to 1995 intramedullary alignment alone was used in 212 knees, and from 1996 to 2001 intramedullary alignment with a custom tibial planing tool was used in 120 knees. All patients were evaluated three months postoperatively with use of weight-bearing 1.3-m (51-in) anteroposterior and lateral radiographs. Knee alignment data for groups treated with extramedullary and intramedullary tibial alignment cutting systems have been reported previously¹⁰. For the purposes of the present study, the radiographs of 100 knees were randomly selected from the original cohort of 212 knees that had undergone traditional intramedullary alignment. The group that was treated with intramedullary alignment with a custom tibial planing tool comprised 120 knees. All anteroposterior radiographs were analyzed. Lateral radiographs were considered to be satisfactory if the knee was well centered without substantial limb rotation and if the entire tibia and the superior part of the talar dome could be visualized. The alignment of the femoral pegs on the lateral radiograph was used to determine limb rotation. We assumed that complete overlap between the two pegs denoted no limb rotation relative to the radiographic plate. Partial overlap was considered acceptable. However, if the two pegs could be seen individually, the radiograph was rejected. A total of 100 anteroposterior radiographs and sixty-five lateral radiographs were analyzed for the group that was treated with traditional intramedullary alignment instrumentation alone, and a total of 120 anteroposterior radiographs and fifty-five lateral radiographs were analyzed for the group that was treated with intramedullary alignment with the custom tibial planing tool.

The PFC knee design (DePuy, Johnson and Johnson, Warsaw, Indiana) was implanted in the group that was treated with traditional intramedullary alignment instrumentation. The PFC Sigma femoral component (DePuy, Johnson and Johnson) was implanted in the group that was treated with intramedullary alignment with the custom tibial planing tool. The major change in the femoral design was in the coronal conformity between the articulating surfaces of the femoral condyles and polyethylene insert and in the trochlear groove. However, the same PFC tibial tray design was implanted in both groups.

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Fig. 2-A and Fig. 2-B: Figs. 2-A through 2-D Intraoperative photographs illustrating the sequence of steps involved in the surgical technique. Fig. 2-A The tibial cut appears to be good when measured with the flat plate alone. Fig. 2-B When the flat plate is threaded over the intramedullary rod, the difference in angulation is more readily seen.

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Fig. 2-C and Fig. 2-D: Fig. 2-C The custom planer is threaded on the intramedullary rod. The handle is moved back and forth through an arc while the cutting surface of the planer is held against the tibial bone cut to realign the cut and to remove any imperfections. Fig. 2-D The tibial cut is now correctly aligned.

A medial parapatellar vastus medialis obliquus-splitting approach was used in all patients. This approach was not "minimally invasive," and the patella was everted. A measured resection approach was used to make the bone cuts. The femoral cuts were made before the tibial cut. The instrumentation was set to achieve a target distal femoral cut of 6° of anatomic valgus, a target posterior femoral cut of 3° of external rotation relative to the posterior condyles, and a target tibial cut of 90° relative to the anatomic shaft axis of the tibia in the coronal plane and of 85° in the sagittal plane (for 5° of posterior slope). All components were cemented.

Standard surgical instrumentation for intramedullary alignment was used to make the proximal tibial cut in both groups. In the first group, only traditional instrumentation was used. In the second group, in addition to standard instrumentation, a custom planing tool was used to check the surface of the tibia and to make adjustments to any imperfections in the tibial cut. The accuracy of the tibial cut in both planes was then checked by sliding a flat plate attached to a trunnion over the intramedullary guide (Figs. 1 and 2-A). Deviation from the desired 90° coronal and 85° sagittal alignment could be visualized as a gap between the flat plate and the cut tibial surface (Fig. 2-B). If a gap was detected, the flat plate was removed and the custom planing tool was then slid down the intramedullary guide and was used to change the angle of the tibial cut (Fig. 2-C). The flat plate was used again to test the alignment of the bone cut. The planing tool was used primarily to remove any residual imperfections in the tibial cut and not for major correction. In addition to the custom planing tool, a rasp was used to remove surface irregularities and to improve the flatness of the cut. The process was repeated, if necessary, until no gap was visible between the flat plate and the tibial bone cut (Fig. 2-D). The rest of the surgical procedure, including trial insert selection and cementing of the prosthesis, was similar for both groups.

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Fig. 3: Histogram illustrating the distribution of coronal tibial component alignment for the group that was treated with traditional intramedullary alignment instrumentation only (IM) and the group that was treated with use of the custom planing tool (IMP). Note the reduced variation in alignment for the latter group.

On the anteroposterior radiograph, the axis of the tibial shaft was defined by a line joining the center of the proximal tibial cut and the center of the body of the talus. A second line was drawn parallel to the undersurface of the tibial component. The medial angle formed between these two lines was measured to yield the coronal alignment of the tibial component. A coronal alignment angle was measured against the target alignment of 90°. An angle of <90° was classified as varus alignment of the component, whereas an angle of >90° was classified as valgus alignment. Similarly, on the lateral radiograph, the axis of the tibial shaft was defined by a line joining the center of the body of the talus and the center of the proximal tibial cut in the lateral view. The posterior angle formed by the undersurface of the tibial component and the tibial axis was measured. The sagittal alignment was compared against the target angle of 85° (the target implantation had a 5° posterior slope). All measurements were made manually on radiographs by two independent observers (S.P. and C.W.C. Jr.). The mean of two measurements was recorded for each radiograph. In 93% (409) of the 440 radiographs that were measured, there was a disagreement of =1°, in 6% (twenty-six) there was a disagreement of 2°, and in 1% (five) there was a disagreement of 3°.

The Student t test was used to test for significant differences between the groups with regard to mean alignment. The level of significance was set at p = 0.05. A sample size of 100 was estimated to be sufficient to detect a difference in mean alignment (and standard deviation) of 1° ± 2° between groups with a power of >90% (alpha = 0.05). The F test was used to detect differences in variance between the groups. The Fisher exact test was used to test for significant differences between the groups with regard to the distribution of cases that were within 1°, 2°, or 3° of the target alignment.

Results

Materials and Methods | Results | Discussion | References

The mean coronal alignment of the tibial component was 89.5° ± 2.1° in the group that was treated with traditional instrumentation alone and 89.6° ± 1.4° in the group that was treated with use of the custom tibial planing tool (p = 0.52). However, the variance in the data was significantly reduced in the group that was treated with use of the custom planing tool (p < 0.001). The frequency distribution of coronal alignment for the two groups is shown in Figure 3. Significantly more tibial components were within 1°, 2°, and 3° of target alignment in the group that was treated with use of the custom tibial planing tool than in the group that was treated with traditional intramedullary alignment instrumentation alone (p < 0.001, p < 0.001, and p = 0.05, respectively; Fisher exact test). The proportion of tibial components that were within 3° of the target coronal alignment was 100% in the group that was treated with use of the custom tibial planing tool, compared with 87% in the group that was treated with traditional intramedullary alignment instrumentation alone (p = 0.05). In both groups, the tendency was for more components to be implanted in varus than in valgus.

The mean sagittal alignment was 86.4° ± 3.2° in the group that was treated with traditional intramedullary alignment instrumentation alone and 84.3° ± 1.6° in the group that was treated with use of the custom tibial planing tool (p < 0.001). As was the case for coronal alignment, the variance was significantly lower in the group that was treated with use of the custom planing tool (p < 0.001). Significantly more tibial components were within 1°, 2°, and 3° of the target sagittal alignment in the group that was treated with use of the custom tibial planing tool than in the group that was treated with traditional instrumentation alone (p = 0.01, p = 0.05, and p < 0.001, respectively; Fisher exact test). The proportion of components that were within 3° of the target alignment was 98% in the group that was treated with use of the custom tibial planing tool, compared with 75% for the group that was treated with traditional instrumentation only (p < 0.001). The mean operative times for both groups were very similar: 118.5 ± 38.6 minutes for the group that was treated with traditional instrumentation alone and 118.7 ± 36.9 minutes for the group that was treated with use of the custom tibial planing tool (p = 0.97).

Discussion

Materials and Methods | Results | Discussion | References

In the present study, the mean coronal alignment was similar between the group that was treated with traditional instrumentation alone and the group that was treated with use of the custom tibial planing tool. However, the deviation from target coronal alignment (90° between the tibial tray and the long axis of tibial shaft) was substantially reduced in the group that was treated with use of the custom tibial planing tool as evidenced by the reduced variation in the data. In fact, all of the tibial components in the group that was treated with use of the custom tibial planing tool were within 3° of target alignment, compared with only 87% of the components in the group that was treated with traditional instrumentation alone. Errors in the tibial cut may be introduced as a result of flex in the saw blades, unstable cutting blocks, play in the cutting jig, or imprecise surgical technique^9,11,12. For example, a mean difference between cutting block alignment and final bone cut alignment of 0.5° in the coronal plane was recorded with use of computer navigation⁹. The difference was attributed to the cumulative cutting error associated with the instrumentation. On the basis of our results, these errors can effectively be reduced with the use of a tool that detects and smoothes out imperfections in the tibial cut.

The accuracy of extramedullary as compared with intramedullary alignment for guiding the proximal tibial bone cut has been evaluated before. Several studies have demonstrated no significant difference between these two methods^10,13,14. Other studies, including one prospective, randomized trial, have demonstrated that intramedullary alignment was more accurate than extramedullary alignment^15-18. On the other hand, intramedullary alignment may be less accurate than extramedullary alignment in the presence of tibial deformities or a wide medullary canal^17,19,20. Direct comparisons with previous reports should be made with caution. However, the results of intramedullary alignment alone in the present study were similar to those that have been reported for intramedullary or extramedullary alignment, whereas the use of the custom planing device significantly reduced the variance of coronal tibial alignment (p < 0.001). In the present study, all of the tibial components in the group that was treated with use of the custom planing device were within 3° of target alignment in the coronal plane, which compared favorably with the findings in published reports on intramedullary and extramedullary alignment^10,14,18,21.

Sagittal plane alignment may be an equally important factor in determining prosthetic survival. A number of lateral radiographs could not be measured because of limb rotation; therefore, no definitive conclusions can be made regarding the reduction of outliers in the sagittal plane. Overall, the accuracy of sagittal alignment was less than that of coronal alignment. On the basis of the lateral radiographs that could be analyzed, the accuracy of alignment was substantially greater in the group that was treated with use of the custom tibial planing tool, with 98% of the components in that group being placed within 3° of target alignment, compared with 77% of those in the group that was treated with traditional instrumentation alone.

Computer-assisted surgical devices, image-guided instruments, and active robotic surgery have been proposed to reduce alignment errors and to increase the accuracy and precision of the femoral and tibial cuts^22-24. Several studies have demonstrated that computer-assisted surgical navigation increases the accuracy of component alignment relative to conventional surgical instrumentation and reduces outliers in alignment^25-30. The reduction in outliers with the custom planing device was comparable with that reported for computer-assisted navigation^25-30.

Malalignment of the tibial component alters the distribution of tibial loading and can increase shear forces at the tibiofemoral interface, resulting in increased wear. Several studies have demonstrated that varus tibiofemoral malalignment results in increased wear and a high failure rate^4,31-35. A threshold of 3° of varus malalignment has been reported to significantly increase the risk of medial bone collapse (hazard ratio = 17.2, p < 0.0001)³⁶. In the present study, although the mean tibial alignment was similar in both groups, 100% of the tibial trays in the group that was treated with use of the custom tibial planing tool were within 3° of neutral alignment whereas only 87% of the trays in the group that was treated with traditional instrumentation alone were in this range. This finding suggests that the planing device was effective for reducing clinically relevant magnitudes of malalignment, thus reducing the potential risk of implant failure.

The present study was a comparison of sequential cohorts. A different femoral component design was used in each cohort. However, the tibial tray instrumentation for intramedullary alignment and the cutting blocks used were similar in both cohorts. The accuracy of measurement of tibial component alignment on radiographs has been shown to be sensitive to limb rotation³⁷. Radiographs in which the implant appeared to be rotated were therefore not included in the analysis. A large number of the lateral radiographs were excluded for this reason. Therefore, firm conclusions cannot be made regarding the efficacy of this device in reducing outliers in sagittal alignment. This limitation of radiographic analysis is present in the vast majority of the studies of component alignment cited above. However, a recent study validated similar radiographic measurements, with a mean difference of only 0.9° between radiographic measurement and computerized tomographic scanograms²¹.

Currently, computer-navigation systems are expensive, involve a considerable learning curve, and usually add to the overall operative time, all of which generate resistance to their universal acceptance. Developments are under way to reduce the cost and improve the efficiency of these navigation systems. Computer-navigation systems also have the advantage of improving femoral and overall limb alignment in addition to tibial alignment. However, a simple, inexpensive tool for improving the accuracy of tibial coronal alignment can match the performance reported by most computer-assisted surgical instrumentation.

References

Materials and Methods | Results | Discussion | References

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Topics

tibia ; knee replacement arthroplasty

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Shantanu Patil, Darryl D. D'Lima, James M. Fait, Clifford W. ColwellJr.; Improving Tibial Component Coronal Alignment During Total Knee Arthroplasty with Use of a Tibial Planing Device. The Journal of Bone & Joint Surgery. 2007 Feb;89(2):381-387.

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