The traditional method of soft-tissue balancing during TKA is subjective in nature, and stiffness and instability are common indications for revision, suggesting that TKA balancing by subjective assessment is suboptimal. This study examines the intraoperative mediolateral loads measured with a nanosensor-enabled tibial insert trial and the sequential balancing steps used to achieve quantitative balance. Data obtained from a prospective multicenter study was assessed to determine the effect of targeted ligament release on intra-articular loading, and to understand which types of releases are necessary to achieve quantified ligament balance. A group of 129 patients received sensor-assisted TKA, as part of a prospective multicenter study. Medial and lateral loading data were collected pre-release, during any sequential releases, and post-release. All data were collected at 10, 45, and 90 degrees during range of motion testing. Ligament release type, release technique type, and resultant loading were collected.Introduction & Aims
Methods
Total knee arthroplasty (TKA) patients are consistently reported to be less satisfied than total hip arthroplasty (THA) patients. A patient's perception of success of his/her own total knee is dictated by their levels of post-operative pain and function, and many return to follow-up visits with inexplicable pain and stiffness that contradict favorable radiographic results. Several of these chief complaints that contribute to dissatisfaction are associated with soft-tissue imbalance. Therefore, in an effort to thoroughly understand the post-operative impact of soft-tissue balance on satisfaction, a multicenter study was conducted to evaluate the satisfaction outcomes of quantifiably balanced patients. In this study, 102 sensor-assisted patients were followed out to 3 years. The intraoperative devices used in this study project kinetic loading (lbf.) and center of load location data, in real-time, to a screen. Because of the wireless nature of the intraoperative sensors, the patella can be reduced, and kinematic data can be evaluated through the range of motion. The target balance window that was used in this study has been previously reported in literature and includes: 1) a mediolateral differential of 15 lbf., through the ROM, and 2) Sagittal plane stability as determined by a posterior drawer analysis. A robust, face-validated satisfaction survey was administered at 3-year follow-up and included 7 questions with answers on a 5-point Likert scale. At 3 years, post-operatively, 97.2% of this patient group reported being “satisfied” to “very satisfied” with their procedure, in comparison to the 81% average TKA satisfaction reported in literature (df = 11). The comparative literature included annual satisfaction intervals from 1 to 5 years (n = 33,775) which is comparable to the interval reported in this patient group. The sensor-assisted patient group exhibited a 16% increase in the proportion of satisfaction over what is currently reported in the comparative literature (p = 0.001). Despite the success rate of TKA, unfavorable patient-reported satisfaction continues to present a problem for operative recipients and surgeons. Because satisfaction is dependent upon several variables – including pain, function, and activity levels – the satisfaction survey used in this study represents a more accurate account of patient perception than many traditional surveys. It was shown that sensor-balanced TKA patients exhibited a 16% increase in the proportion of those reporting being “satisfied” to “very satisfied”, over the average satisfaction reported in literature. Allowing the surgeon to quantitatively balance the soft-tissue envelope, dynamically, has continued to a significant decrease in the proportion of dissatisfaction.
The rate of technological innovation in procedural total knee arthroplasty has left little time for critical evaluation of a new technology before the adoption of even newer modalities. With more drastic financial restrictions being placed on operating room spending, orthopaedic surgeons are now required to provide excellent results on a budget. It is integral that both clinical efficacy and cost-effectiveness of these intraoperative technologies be fully understood in order to provide patients with effectual, economically conscious care. The purpose of this qualitative analysis of literature was to evaluate clinical and economic efficacy of the three most prominent technologies currently used in TKA: computer navigation, patient-specific instrumentation, and kinetic sensors. Three hundred and ninety one publications were collected; 100 were included in final qualitative analysis. Criteria for inclusion in the analysis was defined only insofar as that each piece assessed one of the above listed aspects of the three technologies Literature included in the final evaluation contained background information on each respective technology, clinical outcomes, revision rates, and/or cost analyses. All comparisons were conducted in a strictly qualitative manner, and no attempts were made to conduct interstudy statistical analyses due to the high level of variability in methodology and data collected.Introduction
Methods
Instability after total knee arthroplasty (TKA) represents, in excess of, 7% of reasons for implant failure. This mode of failure is correlated with soft-tissue imbalance, and has continued to be problematic despite advances in implant technology. Thus, understanding the options available to execute safe and effective soft-tissue release is critical to mitigating future complications due to instability. This study aimed to use intraoperative sensors to evaluate a multiple needle puncturing technique (MNPT), in comparison with traditional transection-based release, to determine its biomechanical and clinical efficacy. Seventy-five consecutive, cruciate-retaining TKAs were performed, as part of an 8-site multicenter study. All procedures were performed with the use of an intraoperative sensor to ensure quantitative balance, as per previously reported literature. Of the 75-patient cohort, 50 patients were balanced with the MNPT; 20 patients were balanced with traditional transection. All patients were followed out to 1-year, and administered KSS, WOMAC, and satisfaction. Alignment and ROM was captured for all patients, pre-operatively and at the 1-year follow-up interval.Introduction
Methods
Aseptic loosening has been reported to be the most common, contemporary mode of total knee arthroplasty failure. It has been suggested that the etiology of revision due to loosening can be attributed, in part, to joint imbalance and the variability inherent in standard surgical techniques. Due to the high prevalence of revision, the purpose of this study was to quantify the change in kinetic loading of the knee joint before versus after the application of the final cement-component complex. Ninety-two consecutive, cruciate-retaining TKAs were performed, between March 2014 and June 2014, by two collaborating surgeons. Two different knee systems were used, each with a different viscosity cement type (either medium viscosity or high viscosity). All knees were initially balanced using a microelectronic tibial insert, which provides real-time feedback of femoral contact points and joint kinetics. After the post-balance loads were captured, and the surgeon was satisfied with joint balance, the final components were cemented into place, and the sensor was re-inserted to capture any change in loading due to cementing technique.Introduction
Methods
Achieving balance in TKA is critical in assuring favorable outcomes. But, in order to achieve quantifiably balanced loading values, is it more advantageous to make bony corrections or release soft-tissue? The answer to this question will be paramount in evaluating the most appropriate surgical techniques for use with new dynamic technology, thereby maximizing favorable clinical outcomes. Therefore, the purpose of this investigation was to evaluate a possible quantitative loading threshold, using intraoperative sensors, which may dictate surgical correction of bone versus soft-tissue release. A retrospective analysis of 122 multicenter patients, in receipt of sensor-assisted primary TKA, was conducted. 40 lbs. was used as a threshold, above which bone was corrected; below which soft-tissue was corrected. All patients were categorized in to the following groups: Group A – candidates for bony correction, but received soft-tissue correction; Group B – candidates for soft-tissue/receiving soft-tissue; Group C – candidates for bony correction/receiving bony correction.INTRODUCTION
METHODS
Patient-reported satisfaction is a critical measure in understanding the clinical success of total knee arthroplasty. Yet, satisfaction levels in TKA patients are generally lower than THA patients; and surgeon-patient agreeability regarding clinical success is typically in discordance. Thus, the purpose of this evaluation was to report on the one-year satisfaction data of a group of sensor-assisted TKA patients, and compare that data to the average satisfaction reported in literature, as measured by a meta-analysis. One hundred and thirty five patients received TKA utilizing intra-operative sensing technology to evaluate soft-tissue balance as part of a prospective multicenter study. Patients were classified by two groups: “balanced” and “unbalanced”. Quantitative “balance” was defined as a mediolateral intercompartmental loading difference of ≤ 15 pounds; all loading exceeding 15 pounds was classified as “unbalanced”. At the one-year follow-up visit, a 7-question patient satisfaction survey was administered. The answering schema of this survey was modeled using a modified five-point Likert scale, ranging from “True” to “False” (or “Very Satisfied” to “Very Dissatisfied,” where appropriate). A meta-analysis of literature was performed and studies selected for inclusion in this analysis were required to meet the following criteria: all patients were in receipt of a primary TKA; satisfaction data was collected post-operatively; and the proportion of patients who were “satisfied” to “very satisfied” was statistically described.INTRODUCTION
METHODS
The cost associated with the TKA revision burden is projected to reach 13 billion dollars, annually. Complications reported by post-TKA patients include: pain (44%, multilocational), sensation of instability (21% reason for revision), and joint stiffness (17% reason for revision); problems that may be attributed to soft-tissue imbalance. One of the possible reasons for the substantial prevalence of such complications is the subjectivity associated with defining soft-tissue balance. A priority must be placed on developing new objective methods with which to avoid costly post-operative complications, including the integration of intraoperative sensing technology. The purpose of this evaluation was to report on the disparity between the patient-reported outcomes scores of quantitatively balanced versus unbalanced patients, at 1-year, using a group of 135 multicenter patients. 135 prospective patients, from 8 U.S. sites, have had primary TKA performed with the use of intraoperative sensors. Patients were classified by two groups: “balanced” and “unbalanced”. Quantitative “balance” was defined as a mediolateral intercompartmental loading difference of ≤ 15 pounds; all loading exceeding 15 pounds was classified as “unbalanced”. For all patients, the following kinematic data was captured: varus/valgus stability, anteroposterior stability, flexion contracture (if any), extension lag (if any), anatomic alignment, and ROM. Also at each clinical follow-up visit, activity levels and two patient-reported outcomes measures were administered, including: the American Knee Society Score (KSS), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).INTRODUCTION
METHODS
During primary total knee arthroplasty, the surgeon may encounter excessive medial collateral ligament tension while addressing a varus knee. This may be due to medial ligament/capsular complex contractures, and/or, due to the creation of a 0 degree mechanical axis in a varus knee. This tension leads to increased loading in the medial compartment, which contributes to an unbalanced extension and flexion gap. If uncorrected, this imbalance can lead to unfavorable clinical outcomes, including: pain, accelerated polyethylene degradation, joint instability, and limited ROM. Currently, intercompartmental soft-tissue balance is obtained by a subjective surgeon's “feel”. However, this method of judging soft-tissue tension is both variable and unreliable. Most surgeons can detect gross instability, but judging ligament tension is difficult. The following technique describes the integration of intraoperative microelectronic tibial inserts to assess and modify ligament tension, utilizing real-time dynamic sensor feedback 500 TKAs were performed between September 2012 and April 2013, by three collaborating surgeons. All surgeons used the same implant system, compatible with an embedded microelectronic tibial insert with which to receive real-time feedback of femoral contact points and joint kinetics. Intraoperative kinematic data, displayed loading patterns consistent with identifiable intercompartmental imbalance through a full ROM. All mediolateral imbalance, secondary to an excessively tight medial compartment, was addressed with the technique described herein.Introduction
Methods
Post-operative clinical outcomes of TKA are dependent on a multitude of surgical and patient-specific factors. Malrotation of the femoral and/or tibial component is associated with pain, accelerated wear of the tibial insert, joint instability, and unfavorable patellar tracking and dislocation. Using the transepicondylar axis to guide implantation of the femoral component is considered to be an accurate anatomical reference and is widely used. However, no gold standard currently exists with respect to ensuring optimal rotation of the tibial tray. Literature has suggested that implantation methods, which reference the tibial tubercle, reduce positioning outliers with more consistency than other anatomical landmarks. Therefore, the purpose of this evaluation is to use data collected from intraoperative sensors to assess the true rotational accuracy of using the mid-medial third of the tibial tubercle in 98 TKAs. The data for this evaluation was retrieved from 98 consecutive patients who underwent primary TKA from the same highly experienced surgeon. Femoral component rotation was verified in every case via the use of the Whiteside line, referencing the transepicondylar axis, and confirming appropriate patellar tracking. Tibial tray rotation was initially established by location of the mid-medial third of the tibial tubercle. Rotational adjustments of the tibial tray were evaluated in real-time, as the surgeon corrected any tibiofemoral incongruency and tray malpositioning. The initial and final angles of tibial tray rotation were captured with intraoperative video feed, and recorded. A z-test of differences between pre- and post-rotational correction was performed to assess the statistical significance of malrotation present in this cohort.Introduction
Methods
Acetabular component orientation has been linked to hip stability as well as bearing mechanics such as wear. Previous studies have demonstrated wide variations of cup placement in hip arthroplasty using conventional implantation techniques which rely upon either anatomic landmarks or the use of commercial positioning guides. Enabling technologies such as navigation have been used to improve precision and accuracy. Newer technologies such as robotic guidance have been postulated to further improve accuracy. The goal of our study was to evaluate the clinical reproducibility of a consecutive series of haptically guided THR. 119 patients at 4 centers were enrolled. All patients had preoperative CT scans for the purpose of planning cup placement in lateral opening and version using proprietary software (Mako, Ft. Lauderdale, FL). All procedures were performed using a posterolateral approach. Following bone registration, acetabular preparation and component position is performed using haptic guidance. Final implant postion is ascertained by obtaining 5 points about the rim of the acetabular component and recorded. At 6 weeks, all patients had AP and cross-table lateral radiographs which were then analyzed for cup abduction and anteversion using the Hip Analysis Suite software. The goal was to determine the variability between desired preoperative plan, intraoperative measurement and postoperative results.Introduction:
Methods:
Flexion instability of the knee accounts for, up to, 22% of reported revisions following TKA. It can present in the early post-operative phase or present— secondary to a rupture of the PCL— in the late post-operative phase. While most reports of instability occur in conjunction with cruciate retaining implants, instability in a posterior-stabilized knee is not uncommon. Due to the prevalence of revision due to instability, the purpose of constructing the following techniques is to utilize intraoperative sensors to quantify flexion gap stability. 500 posterior cruciate-retaining TKAs were performed between September 2012 and April 2013, by four collaborating surgeons. All surgeons used the same implant system, compatible with a microelectronic tibial insert with which to receive real-time feedback of femoral contact points and joint kinetics. Intraoperative kinematic data, as reported on-screen by the VERASENSE™ knee application, displayed similar loading patterns consistent with identifiable sagittal plane abnormalities. These abnormalities were classified as: “Balanced Flexion Gap,” “Flexion Instability” and “Tight Flexion Gap.” All abnormalities were addressed with the techniques described herein.Introduction
Methods
In total hip arthroplasty, the positioning of the acetabular cup, in particular, has been shown to play an important role in the survivorship of the prosthetic joint. The commonly accepted “safe zone” extends from 5–30° of anteversion to 30–50° of inclination. However, several studies have utilized a more restrictive safe zone of 5–25° of anteversion and 30–45° of inclination, a modification of the Lewinnek zone. Many attempts have been made to develop a more reliable method of positioning the acetabular component. Robotic-assisted surgery is one such method. The purpose of this study was to compare the resulting position of the acetabular component after robotic-assisted surgery with the intraoperative robotic data to determine if improved accuracy can be achieved with the robotic-assisted method. One hundred and nineteen patients received THA, at four different medical centers in the United States, using a haptic robotic arm. Pre-operative CT scans were obtained for all patients and used during the planning of the procedure, at which point the proposed component size and positioning was determined. Preparation of the acetabular bone bed, as well as impaction of the acetabular component itself, was performed using the robotic device. Using an AP Pelvis and Cross-Table Lateral radiograph, each patient's resulting acetabular inclination and version was measured using the Hip Analysis Suite software. The component position retrieved from the robot was compared to the measured values from the radiographs. The positioning data was compared to two safe zones described above.Introduction
Methods
