Introduction

Optimal alignment and position of implants is an important goal In TKA. Conventional mechanical instruments use the anatomic axis and “average” anatomy to position the femoral component to achieve acceptable mechanical limb alignment. Numerous studies have documented the frequency of TKA outliers (+/− 3 degrees) to be 30% or more. The purpose of this study was to determine the “true” distal femoral valgus angle of the femur.

Introduction

Optimal alignment of the tibial component in TKA is an important consideration. General agreement exists on the appropriate coronal alignment. However there is no consensus on sagittal alignment (posterior slope). Some surgeons target a fixed posterior slope (usually between 0 and 10 degrees), while others attempt to match the patient's intrinsic anatomy. The purpose of this study was to evaluate the tibial posterior slope in patients undergoing TKA.

Introduction: Much debate exists regarding sparing or sacrificing the posterior cruciate ligament (PCL). The posterior cruciate ligament is said to maintain proprioception and stabilization post knee arthroplasty. Substitution of the PCL can require more femoral bone resection, but is thought to improve range of motion. Release of the PCL can restore extension and enhance flexion through greater femoral rollback. Bicruciate implants potentially offer greater flexion and enhanced stability. Each implant design with mechanical instruments requires a different surgical technique making it difficult to directly compare the patient and surgical outcomes. Computer navigation eliminates the differences in implantation between the various implant designs and theoretically allows a more direct comparison of implants based on design characteristics and not surgical technique. The purpose of this paper is to review four different implant designs implanted by a single surgeon with a computer assisted, gap balancing technique to determine if there was any difference in patient outcome.

Methods: A total of 504 implants consisting of posterior cruciate sparing (PFC-RP), PCL substituting (PFC-RPC), PCL sacrificing (LCS) and bicruciate (Journey) implants performed by a single surgeon were reviewed. The PFC-RP group (260) was the largest, followed by the LCS (124), the PFC-RPF (80) and the Journey Knee (40). Outcomes reviewed were range of motion, function, pain and radiographic data to include alignment and evidence of radiolucency.

Results: Demographic data of groups compared included 175 men and 329 women. Mean ages ranged from 61 to 74 years. Preoperative scores among all groups were similar with the cruciate substituting group slightly lower in function, flexion and with more pain before surgery. Overall function improved across all groups through two years, with better scores in the Journey and LCS implants (77 and 73 points) versus RPF (47) and PFC retaining group at (68) at one year (A perfect score is 100). Flexion values were comparable between all groups at one and two year intervals with Journey the highest mean flexion (116 degrees) at one year and with the PFC-RP offering the highest mean flexion at the two year mark (115 degrees). The RPF group at the one year mark had more pain overall (28) versus the other three groups (Journey 45, LCS 42, Sigma RP 45). No patients in any group were revised for instability. Other surgical complications were equal in each group.

Discussion: While the PCL substituting knee patients (PFC-RPF) had lower pain, function and flexion at 12 months compared to all other groups, they started with lower overall knee scores. After accounting for the differences in patients preoperatively, no difference could be found between implant designs when implanted with a similar surgical technique employing a computer assisted gap balancing protocol.

Introduction: While computer navigation has been shown to improve radiographic alignment and eliminate outliers in limb and component position in total joint arthoplasty, adoption has been relatively slow. One argument against the use of navigation has been the concern about the cost of the capital equipment and surgical disposables. The purpose of this paper was to evaluate whether the direct cost of patient care was greater for the senior author, who navigates all joint replacements, than other surgeons, who perform total joint arthroplasty without navigation.

Methods: The author’s institution is a 200 bed community hospital that performs over 1000 joint replacements per year. This study consisted of reviewing the fiscal year 2007 data at the author’s institution and comparing the direct costs of medical care, length of stay and discharge disposition for the senior author to his peers at his institution.

Results: In fiscal year 2007, the hospital performed 624 primary total knee and 213 primary total hip replacements of which the senior author performed 284(45%) knees and 156(73%) hips respectively. The average charge for the entire hospital was $38, 877 and LOS was 2.7 days for knees, and charges of $40, 076 and LOS was 2.7 days for hips. The senior authors charges were $33, 801 and LOS was 2.4 days for knees and $36, 403 and LOS 2.4 for hips. 78% of the knees and 81 % of the hips were discharged to home overall for the institution and 86% of both knees and hips by the senior author. The capital equipment purchase for navigation was $204,000 or $463 per primary arthroplasty(senior author).

Conclusions: Computer navigation did not increase the direct cost of primary total joint replacement for the senior author relative to his peers even if the entire capital equipment purchase was added to the case cost.

Computer assisted surgical techniques in total knee arthroplasty have demonstrated increased accuracy of alignment and decreased risk of outliers. Some studies have also demonstrated improved early functional results and pain scores in comparison to traditional surgical methods. Studies have also shown a slightly increased surgical time for computer assisted surgery. A learning curve for computer assisted surgery is recognized, and there may be different outcomes for cases performed initially during the learning phase. This study reports on a single surgeon’s experience with the initial 261 computer assisted total knee arthroplasties.

A single experienced, fellowship trained surgeon performed computer assisted total knee arthroplasty utilizing either the BrainLab or Ci intraoperative navigation system and either the LCS Complete Mobile Bearing Knee System (DePuy) or Sigma PFC Rotating Platform (DePuy). Preoperative and postoperative data was recorded prospectively (DePuy Captureware) of the initial 261 consecutive cases at minimum of one year follow-up. SAS 9.1 was used to perform univariate and multivariate analyses of four groups of patients: patients 1–77, patients 78–135, patients 136–211 and patients 212–261. Multivariate analyses were performed to control for body mass index, age, sex, implant type, pre-operative range of motion, preoperative function and preoperative pain scores.

Multivariate analysis of these four groups demonstrated that there was no statistically significant difference in the improvement of postoperative function (p=0.29) and pain scores (p=0.28) among the patients in the four groups at minimum one year follow-up. There was a statistically significant difference in improvement of postoperative extension (p=0.0022) and flexion (p=0.0139) scores with subsequent surgeries, however the range of improvement for the groups was not clinically significant (extension ranging from 1.97 to 5.92 degrees gained in the four groups, and flexion loss of 0.67 degrees to gain of 6.18 degrees in the four groups). The number of patients requiring a hospitalization greater than two days decreased with each subsequent group which was clinically significant (p=0.021, p=0.001, p< 0.0001 for the second, third and fourth groups, respectively).

For an experienced reconstructive surgeon incorporating computer assisted surgery into his total knee arthroplasty practice, there is no significant learning curve in regards to intermediate term outcomes. Patients undergoing computer assisted total knee arthroplasty have similar intermediate outcomes whether performed earlier in that surgeon’s experience or later. Patients did initially have shorter hospitalization stays in subsequent groups. However, at an intermediate follow-up period of one year, there is no significant difference in patients’ postoperative improvement in function, pain score, knee flexion and knee extension.

Computer navigation in total joint arthroplasty has been shown to be effective in improving the radiographic outcome in patients undergoing both hip and knee arthroplasty. However, critics have argued that the required capital equipment and added time to perform the procedure is cost prohibitive. To test this hypothesis, we compared our hospital discharge experience with computer navigation to national standards published by the Agency for Healthcare Research and Quality for the years 2004 and 2005

In the AHRQ database the average length of stay for DRG 209 in 2004 and 2005 respectively, in the Midwest region was 4.6 days and 4.3 days, with a mean charge of $27,403 and $27,948, with only 40% and 45%, of patients discharged to home with or without home health care. In 2004 and 2005, the senior author performed 125 and 117 Medicare primary hip and knee replacements, respectively, with computer navigation with a mean length of stay of 2.9 days and 2.8 days, with charges of $22,134 and $24,612, and 63% and 71% discharged to home.

On a pure charge basis, the senior author experience a decreased overall charge compared to published data. Even if the entire cost of the navigation system in our system $204,000 was spread equally over only the Medicare patients over the two year period, the additional $842/case still results in a case charge below published data.

Based on the senior author’s experience with hospitalization cost, length of stay and discharge disposition, computer navigation in total joint replacement is not associated with an increased cost/case and may result in dramatically lower indirect costs due to shorter length of stay and increased number of discharges to home compared to published regional Medicare discharge data.

Studies suggest that specialty hospitals and high surgical volume decrease adverse outcomes related to hip arthroplasty. Little is known, however, concerning the influence of imageless computer navigation systems on a surgeon’s experience and subsequent placement of implants in the setting of hip resurfacing arthroplasty.

A retrospective review of 71 consecutive hip resurfacing arthroplasties placed with computer assisted navigation during 2006 and 2007 was performed. Forty-seven operative days encompassing the surgeon’s entire experience with hip resurfacing were analysed. Within this single surgeon series, operative time, intraoperative cup inclination and femoral stem/shaft angles, as well as postoperative cup inclination and femoral stem/shaft angles were measured and compared over three discreet, sequential operative time intervals.

Intraoperative cup inclination angles were comparable to postoperative radiographic values as there was no significant difference (p=.059). Computer assisted navigation produced consistent values despite different levels of surgeon experience in the setting of intraoperative cup inclination (42.8°, 43.5°, and 40.1°) and postoperative cup (46.1°, 43.9°, and 42.9°) and femoral stem (147.9°, 146.5°, and 144.0°) radiographic alignment. A statistically significant difference existed between intraoperative femoral stem/shaft angles compared to postoperative radiographs measurements (p< .001), however, all means maintained a valgus orientation compared to the native neck angle. There was a correlation between evolving surgeon experience and intraoperative stem placement (143.5°, 142.1°, and 138.0°, respectively) despite the mean values remaining well clustered (p< .001). Operative times significantly decreased (p< .001) with surgeon experience, showing the largest decrease after the 1^st sequence interval (109.6, 97.8, and 94.8 min, respectively). No femoral notching (0/71) occurred throughout the series.

Computer assisted navigation provides a dependable method of accurate hip resurfacing arthroplasty component positioning as measured by cup inclination, in addition to a reliable technique for valgus stem placement and avoidance of notching. Furthermore, computer navigation allows for consistency and offers a protective effect on component alignment independent of surgeon procedural experience.

The Vector Vision CT free navigation system of Brain-Lab (Heimstetten, Germany) for total knee arthroplasty incorporates a ligament balancing feature which allows recording of flexion extension gaps and clinical alignment [3]. Since routine spacer blocks do not necessarily load the joint space symmetrically, if either the bone cuts are asymmetric or the ligaments are not evenly balanced, a tensioning device that applies a constant load to the medial and lateral joint space separately and which can collapse or expand on each side independently should be able to provide a better evaluation of ligament tension and allow the computer software to better plan the appropriate bone cuts or ligament release. The tensioning device comprises 2 linked plates contacting the femur and tibia separated by two independent springs in the medial and lateral compartments. It can be positioned precisely in the joint with the navigation system and, with respect to spacer blocks, this device was designed in order to allow a dynamic evaluation of joint stiffness during all range of motion and, thanks to it’s reduced dimensions, with patella in situ. The springs apply a consistent known force on the compartments, while at the same time the gap produced by the applied forces is measured by the navigation. This study integrates previous article [1] on the validation of the tensioning device and reports the first phase of the clinical validation of the tensioning device, including first qualitative comparison with standard navigated technique and consideration on the use of the device.

A spring loaded mechanical device was designed with a constant 6kg load in the springs for each compartment. For the clinical evaluation, the device was inserted into flexion and extension spaces after the tibial cut was performed in routine computer assisted total knee arthroplasty. The gap produced by the applied forces is measured, by the navigation system, as the distance between tibial cut and most distal points on condyles in extension or most posterior points on condyles in flexion. Under the same conditions a set of solid spacer blocks were inserted to obtain a gap able to balance the knee according to surgeon’s sensitivity. This gap was used as reference and compared with the gap obtained with the spring device. The clinical evaluation was performed in order to determine whether there was a difference between the gaps as indicated by both the tensioning device and the spacer blocks. Five experienced orthopaedic surgeons were involved in a randomized study producing 58 complete data sets. Eight measurements (medial and lateral gap, in flexion and extension for tensioning device and spacer blocks) were taken intra-operatively using the ligament balancing features of the VectorVision system. Because many of the measurements were not normally distributed, nonparametric statistical tests (Mann-Whitney and Wilcoxon) were chosen to look for statistical differences, looking for differences in medians and ranking of data instead of differences in averages and distributions. Repeatability of measurements performed with the spring device was defined as the occurrence of same values obtained with the device and by surgeons with spacer blocks. Since the uncertainty in the measurements, due to optical navigation system is near, differences within a range of ±1mm were considered the same value, moreover data within a range of ±2mm were considered a positive result. This data was analyzed with Minitab software version 13.31.

Results are reported in Tab.1.

Results: extension Flexion compartment Medial lateral medial lateral average difference 0.2 (±2.5 mm) 0.0 (±3.6 mm) 1.3 (±2.1 mm) 1.4 (±2.5 mm) number of cases 57 100 57 100 57 100 57 100 median ±1mm 30 52.6 24 42.1 34 59.6 23 40.4 median ±2mm 43 75.4 36 63.2 47 82.5 36 63.2 Table.1. Average difference between gaps obtained with tensioning device and spacer blocks, and related occurrences in medial\lateral compartments inflexion and extension. Difference between the tensioning device and the spacer blocks in flexion is 0.2mm medially and 0.0mm laterally, while in flexion it is 1.3mm medially and 1.6mm laterally, moreover the alignments of resulting femoral cuts obtained with spring device can be considered the same of the alignments obtained with spacer blocks (difference is < 1°). Data, summarized in Tab.1, highlight that knee has a different behaviour in flexion and extension. Applying the same force with the tensioning device the resulting gap in extension (10mm medial, 10.5mm lateral) is lower than the one flexion (10.5mm medial, 12.5 lateral). The percentage of values around the average in the range of 1mm is 52.6% – 59.6% medially and 40.4% – 42.1% laterally, showing a higher variability on lateral compartment, while the percentage of values in a range of 2mm is75.4% – 82.5% medially and 63.2% laterally, confirming the variability.

Determining the soft tissue balance in total knee replacement is important to proper reconstruction. Traditional spacer blocks are unable to load the medial and lateral joint space independently which may compromise the surgical plan. A tensioning device which loads the-joint space independently with a constant load should theoretically allow proper planning of the bone resections and ligament releases during reconstructive surgery. The spring loaded tensor device coupled with image navigation and compared to independent spacer blocks performed by different surgeons revealed that there is no statistical difference between the gaps obtained with spacer blocks and tensioning device in extension, while in flexion there is an average difference 1.4mm, it revealed also that there was greater surgeon variability in the use of spacer blocks compared to the tensioning device. Furthermore, the device produced results that were similar to the results obtained by the spacer blocks especially when surgeon’s variation in technique was taken into account. The use of a joint tensioning device, coupled with computer assisted surgery, allows planning appropriate bone resection and ligament releases to produce matched medial and lateral joint spaces in flexion and extension. There were no reports, either inter-operatively or post-operatively, of any complications or adverse events nor any malfunctions of the device. On a number of occasions it was felt necessary to perform additional bone resections to allow the insertion of the spring device. However this should be considered as a normal part of TKA and of the inter-operative decision making process. This data also revealed, as would be expected clinically that the joint space is less in extension than in flexion after the tibial cut is performed [3]; surgeons with the help of spacer blocks apply less force in flexion in order to obtain the same gap during range of motion, the spring device, applying always the same force, is opening the joint more in flexion. Furthermore, when evaluating the lateral joint space, the tensioning device has a greater variability than the spacer blocks [4]. In this series of patients, a spring loaded tension device decreased surgeon variability in the assessment of ligament tension and, when coupled with computer navigation, allowed the surgeons to appropriately plan the femoral resection to create balanced flexion and extension spaces.