Contemporary Robotic Systems in Total Knee Arthroplasty: A Review of Accuracy and Outcomes.

The success of total knee arthroplasty (TKA) depends on restoration of the stability and biomechanical efficiency of the native knee. The emergence of robotic surgical technologies has greatly increased the precision and reproducibility. We discuss contemporary robotic TKA systems by reviewing the features of the individual platforms, their accuracy, and the clinical outcomes. While early results suggest significant gains in patient outcomes, long-term evidence is still awaited from multicenter prospective clinical trials. Moreover, advances in this technology are needed to address knee laxity while individualizing the functional performance of each patient's new joint.

3D Printing of a BAHA Protective Cap.

Mechanical feedback is one of the most common difficulties encountered when fitting hearing aids for toddlers and young children. We described the use of 3D printing to tailor a protective cap for a toddler with bilateral microtia/canal atresia to facilitate bone-anchoring hearing aid use.

Appropriateness of the Use of Navigation System in Total Knee Arthroplasty.

BACKGROUD: The aim of this study was to evaluate the difference between the planned and verified actual values in total knee arthroplasty (TKA) performed using a navigation system. METHODS: Sixty patients who underwent primary TKA for knee pain from March 2018 to July 2018 were included in this study. All patients underwent TKA using the latest version of a computer navigation system (Kick ver. 2.6). All TKA procedures were performed by the same surgeon. The appropriateness of the use of navigation system in each of the several steps during the operation was investigated. Implant size was assessed using a preoperative template and after registration of landmarks with the navigation system. Intraoperative measurement was conducted using a femoral sizing implant apparatus. The difference between the planned value based on the navigation system and the actual cutting value was investigated. Intraoperatively confirmed hip-knee-ankle angle was also compared to the angle measured at postoperative 3 months. RESULTS: The average time spent on the registration process was 242 seconds (range, 205-345 seconds). Intraoperative femoral component size tended to be smaller than the size recommended by the navigation system. A significant difference between the planned distal femoral cutting level (9.08 ± 0.40 mm) and the verified actual cutting level (9.87 ± 1.39 mm) was identified (p < 0.05). The difference between the planned lateral and medial tibial resection levels (10.12 ± 0.34 mm and 4.47 ± 2.17 mm, respectively) and the verified actual lateral and medial tibial resection levels (9.07 ± 1.45 mm and 3.48 ± 2.00 mm, respectively) was statistically significant. Distal femoral cutting angle in sagittal plane was significantly different but femoral and tibial cutting angles showed no significant difference between the planned and verified values. At full extension, the average coronal alignment of the implant recorded after insertion of the actual implant using the navigation system was 0.23° ± 0.51° varus and showed no significant difference from the alignment measured at postoperative 3 months (0.45° ± 0.58°). CONCLUSIONS: When performing navigation-assisted TKA, surgeons should aware that frequent errors can occur on the femoral cutting level, tibial cutting level, and implant sizing despite its reported advantage in defining the mechanical limb axis.

Electromagnetic navigation system for acetabular component placement in total hip arthroplasty is more precise and accurate than the freehand technique: a randomized, controlled trial with 84 patients.

Background and purpose - The accuracy of conventional navigation systems depends on precise registration of bony landmarks. We investigated the clinical use of electromagnetic navigation (EMN), with a unique device for precise determination of the anterior pelvic plane. Patients and methods - We randomly allocated patients scheduled for total hip arthroplasty into 2 groups of 42 patients each. In the study group, cups were placed at the predetermined target angles (inclination: 42.5°; anteversion: 15°) with the support of EMN. In the control group, cups were placed freehand aiming at the same target angles. Postoperatively the true position of the cup was determined using computed tomography scan of the pelvis. Precision (root mean squared error, RMSE) bias (mean bias error, ME), accuracy, and duration of surgery were compared between the methods. Results - Cup anteversion was more accurate and precise in the navigated group. The ME in the navigated and freehand group was -1.7° (95% CI -2.4 to 1.1) and -4.5° (CI -6.5 to 2.5), respectively. The RMSE in the navigated and freehand group was 2.8° (CI 2.3-3.2) and 8.0° (CI 6.3-9.5), respectively. The inclination was also more precise in the navigated group, with the RMSE in the navigated and freehand group at 4.6° (CI 3.4-5.9) and 6.5° (CI 5.4-7.5), respectively. The accuracy of the inclination and the duration of surgeries were similar between the groups. Interpretation - Cup placement with the help of EMN is more precise than the freehand technique and it does not affect the duration of surgery.

The effect of the transfemoral prosthetic socket interface designs on skeletal motion and socket comfort: A randomized clinical trial.

BACKGROUND: The most crucial aspect of a prosthesis is the socket, as it will directly determine gait stability and quality. The current standard of care ischial ramus containment socket is reported to increase coronal stability through gait; however, socket discomfort is the primary complaint among prosthetic users. OBJECTIVES: The purpose of this study is to compare ischial ramus containment to alternatives in the transfemoral amputee population. All subjects were fit with three different sockets: traditional ischial ramus containment, a dynamic socket, and a sub-ischial. In this study, authors hypothesized socket skeletal motion would be equivalent across interventions. STUDY DESIGN: Single-blind, repeated-measures, three-period randomized crossover clinical trial. METHODS: Outcome measures were socket comfort score and skeletal motion, viewed coronally with X-ray measuring the position of the skeleton in relationship to the socket in full weight-bearing and full un-loading. RESULTS: The mean age was 38.2 and mean Amputee Mobility Predictor score was 40. Mean vertical movement, horizontal movement, single limb prosthetic stance, mean femoral adduction in swing and stance, and median socket comfort score were not statistically different. CONCLUSION: The socket design did not significantly effect skeletal motion and socket comfort. All socket designs are suitable depending on the patient-centric preferences and prosthetist skill set. CLINICAL RELEVANCE: The comfort of the standard of care transfemoral amputation socket has been widely reported as problematic. A comparison of alternative designs in a controlled clinical trial environment will assist the clinician in understanding the impact of design regarding skeletal motion and comfort. Users could benefit from alternatives applied in clinical practice.

Non-invasive navigation in total knee arthroplasty : a validation study.

The purpose of this study was to evaluate intraope- rative alignment during total knee arthroplasty using a handheld navigation system, iAssist, in comparison with conventional optical surgical navigation. Sixty-two consecutive patients were enrolled in this prospective study. iAssist was used to determine implant component positioning. Orientation of the cuts were verified using a conventional optical sur- gical navigation system. We compared the iAssist system with the conventional system in terms of accuracy, percentage of outliers, bias, and precision. The occurrence of component malalignment was low. Taking standard radiography as the reference, there were no relevant differences between the handheld device and optical navigation in terms of measure- ment of accuracy or in outlier occurrence. Bias was small for both technologies, and precision was comparable. The study provides preliminary evidence that the use of iAssist leads to satisfactory implant alignment. The results from this study imply that iAssist could be a viable alternative to conventional optical navigation.

Evaluation of the accuracy of acetabular cup orientation using the accelerometer-based portable navigation system.

BACKGROUND: Accurate orientation of acetabular and femoral components is important during total hip arthroplasty (THA). In recent years, several navigation systems have been developed. However, these navigation systems for THA are unpopular worldwide because of their high cost. We assessed the orientation accuracy of cups inserted using a disposable accelerometer-based portable navigation system for THAs. METHODS: This was a prospective cohort study. We analyzed 63 hips with navigation prospectively and 30 hips without navigation retrospectively as historical control. The patients underwent THA via the mini anterolateral approach in the supine position using an accelerometer-based portable navigation system. We compared the preoperative target angles, intraoperative cup angles using navigation records, postoperative angles using postoperative CT data, measurement errors of cup angles, and clinical parameters such as sex, treated side, age at surgery, and body mass index (BMI). RESULTS: The average absolute error (postoperative CT-navigation record) was 2.7 ± 2.1° (inclination) and 2.7 ± 1.8° (anteversion), and the absolute error (postoperative CT-preoperative target angle) was 2.6 ± 1.9° (inclination) and 2.7 ± 2.2° (anteversion). The absolute error between postoperative CT and target angle with navigation was significantly lower than the error without navigation (inclination; p = 0.025, anteversion; p = 0.005). Cup malalignment (absolute difference of inclination or anteversion between postoperative CT and preoperative target angle of over 5°) was significantly associated with BMI value (OR: 1.3, 95% CI: 1.1-1.7). The absolute measurement error of cup inclination and anteversion was significantly correlated with patients' BMI (inclination error: correlation coefficient = 0.53, p < 0.001, anteversion error: correlation coefficient = 0.58, p < 0.001). CONCLUSIONS: The clinical accuracy of accelerometer-based portable navigation is precise for the orientation of cup placement, although accurate cup placement was affected by high BMI. This is the first study to report the accuracy of accelerometer-based portable navigation for THA in the supine position.

Improving Tibial Component Coronal Alignment During Total Knee Arthroplasty with the Use of a Double-Check Technique.

OBJECTIVE: To compare the efficacy of the restoration of tibial component coronal alignment with a double-check technique and the conventional surgical technique during total knee arthroplasty (TKA) in knee osteoarthritis patients, and to investigate the distribution of the medial proximal tibial angle (MPTA) after TKA. METHODS: A retrospective review was performed of 151 patients (179 knees) with knee osteoarthritis undergoing primary TKA in Beijing Chaoyang Hospital, Capital Medical University from February 2013 to January 2015 to evaluate the differences in MPTA in patients undergoing the conventional TKA and those undergoing a modified TKA with a double-check technique after the surgery. All patients were evaluated by MPTA, range of motion (ROM), Knee Society Clinical Rating System (KSS) clinical scores, and KSS functional scores. An MPTA deviation of 3° or greater was considered malalignment. RESULTS: A total of 130 TKA procedures in 119 patients were included in the study: 64 knees treated with conventional TKA and 66 knees treated with the double-check technique TKA. The mean postoperative MPTA was 88.6° ± 2.2° in the conventional TKA group and 89.1° ± 1.5° in the double-check TKA group. The mean postoperative MPTA between the two groups was not significantly different. In the conventional TKA group, 79.7% (51 knees) had a postoperative MPTA deviation within 3° and 20.3% (13 knees) had a MPTA deviation greater than 3°. In the double-check TKA group, 93.9% (62 knees) had a postoperative MPTA deviation within 3°and 6.1% (4 knees) had a MPTA deviation greater than 3°. The postoperative MPTA deviation within 3° showed a statistically significant difference between the two groups. In the double-check TKA group, a 21.2% (14 knees) tibial malalignment was detected after the first check and a 9.1% (6 knees) tibial malalignment was detected after the second check. The mean postoperative ROM was 118.1° ± 9.2° in the conventional TKA group and 115.7° ± 10.1° in the double-check TKA group. The mean postoperative KSS clinical score was 89.3 ± 3.5 in the conventional TKA group and 89.0 ± 3.7 in the double-check TKA group. The mean postoperative KSS functional score was 84.8 ± 10.0 in the conventional TKA group and 84.9 ± 9.0 in the double-check TKA group. The mean postoperative ROM, KSS clinical scores, and KSS functional scores between the two groups were not statistically significantly different. CONCLUSION: Malalignment of the tibial component can occur after conventional TKA, and the double-check technique is an effective method to improve tibial component coronal alignment.

High-resolution, real-time, and nonfluoroscopic 3-dimensional cardiac imaging and catheter navigation in humans using a novel dielectric-based system.

BACKGROUND: Catheter navigation and 3-dimensional (3D) cardiac mapping are essential components of minimally invasive electrophysiological procedures. OBJECTIVE: The purpose of this study was to develop a novel 3D mapping system (KODEX - EPD, EPD Solutions, Best, The Netherlands) that measures changing electric field gradients induced on intracardiac electrodes to enable catheter localization and real-time 3D cardiac mapping. METHODS: We first validated the accuracy of the system's measurement and localization capabilities by comparing known and KODEX - EPD-measured distances and locations at 12 anatomical landmarks in both the atria and ventricles of 4 swine. Next, in vivo images of 3D porcine cardiac anatomy generated by KODEX - EPD and widely used CARTO 3 system (Biosense Webster, Inc., Diamond Bar, CA) were compared with gold standard computed tomography images acquired from the same animals. Finally, 3D maps of atrial anatomy were created for 22 patients with paroxysmal atrial fibrillation (Dielectric Unravelling of Radiofrequency ABLation Effectiveness trial). RESULTS: First, the mean error between known and measured distances was 1.08 ± 0.11 mm (P < .01) and the overall standard deviation between known and measured locations in 12 areas of the porcine heart was 0.35 mm (P < .01). Second, an expert comparison of 3D image quality revealed that KODEX - EPD is noninferior to CARTO 3. Third, the system enabled 3D imaging of atrial anatomy in humans, provided real-time images of atrioventricular valves, and detected important anatomical variations in a subset of patients. CONCLUSION: The KODEX - EPD system is a novel 3D mapping system that accurately detects catheter location and can generate high-resolution images without the need for preacquired imaging, specialty catheters, or a point-by-point mapping procedure.

Posterior condylar resections in total knee arthroplasty: current standard instruments do not restore femoral condylar anatomy.

INTRODUCTION: Correct femoral rotational alignment in total knee arthroplasty (TKA) is important for femoropatellar knee kinematics as well as for the overall clinical success. The goal of the present study was to evaluate how accurately standard instruments of various manufacturers with specific rotational settings in posterior referencing restore the posterior femoral condylar anatomy and allow a rotational alignment which matches a particular anatomic rotational landmark on CT. METHODS: The anatomical transepicondylar axis (aTEA) and the posterior condylar line (PCL) were identified and the angle formed by these two axes was measured on 100 consecutive CT scans of knees. A virtual posterior condylar resection was performed relative to the aTEA for femoral sizers of various manufacturers in different external rotations ranging from 3° to 7°. The resections of medial and lateral posterior condyle were calculated as well as the condylar twist angle (CTA) between PCL and aTEA. RESULTS: The posterior condylar resection varied between 9 mm and 14 mm on the medial side and between 4 mm and 10.5 mm on the lateral side. The mean CTA was 5.5° of internal rotation (SD ± 1.9°). External femoral rotation resulted in increased resection of the medial posterior condyle and decreased resection of the lateral posterior condyle. CONCLUSION: Femoral sizers using a posterior referencing technique increase, with rising external rotation, medial posterior condylar resection to an extent that may exceed the implant thickness in the majority of systems. Surgeons should be aware that current standard instruments do not restore the anatomy of the posterior medial and lateral condyle and do not align the femoral component parallel to the aTEA, which may result in internal rotation of a symmetric femoral component.

Postoperative mechanical alignment analysis of total knee replacement patients operated with 3D printed patient specific instruments: A Prospective Cohort Study.

OBJECTIVE: Total knee replacement (TKR) is a surgical treatment for final stage gonarthrosis. The lifespan of the prosthetic implants used in TKR surgery is a major interest for the orthopaedic research community.Previously, proper implant alignment of the implants has been advocated for longevity of the TKR surgery. Recently, patient-specific (PSI) instruments have been proposed to improve the mechanical alignment of the TKR by permitting better implant positioning over conventional TKR surgery. The aim of this study is to compare the mechanical alignment results of patients operated with PSIs and conventional instruments. METHODS: Two groups of 20 patients chosen in a quasi-random manner have been compared in this study. In the first group femoral distal and tibial osteotomies were made by a PSI which was produced by the patients' computed tomography scans. All osteotomies in the control group were made with the TKR set's routine instruments by conventional means. Patients' preoperative and postoperative mechanical femorotibal angles (mFTA), femoral coronal angles (FCA), tibial coronal angles (TCA) were measured and the number of outliers which showed more than 3° of malalignment were counted in both groups for comparison. RESULTS: The average postoperative mFTA was found to be 2.09° for the PSI group and in was found to be 2.84° for the control which was not statistically significant. The comparison of postoperative FCA and TCA also did not show significant difference between the groups. The number of outliers showing more than 3° of malalignment per group were found to be 1 out of 20 (5%) for the PSI group and 7 out of 20 (35%) for the control which was statistically significant. CONCLUSION: In this study patient-specific instrumentation provided significantly better mechanical alignment compared to conventional TKR for the frequency of outlier cases with malalignment beyond 3°. PSI proved no significant difference when the groups were compared for mFTA, FCA and TCA. Our findings support that PSI may improve TKR alignment by improving the ratio of the outlier patients with marked malalignment. LEVEL OF EVIDENCE: Level III, Therapeutic Study.

A Two-Dimensional Wireless and Passive Sensor for Stress Monitoring.

A new two-dimensional wireless and passive stress sensor using the inverse magnetostrictive effect is proposed, designed, analyzed, fabricated, and tested in this work. Three pieces of magnetostrictive material are bonded on the surface of a smart elastomer structure base to form the sensor. Using the external load, an amplitude change in the higher-order harmonic signal of the magnetic material is detected (as a result of the passive variation of the magnetic permeability wirelessly). The finite element method (FEM) is used to accomplish the design and analysis process. The strain-sensitive regions of the tension and torque are distributed at different locations, following the FEM analysis. After the fabrication of a sensor prototype, the mechanical output performance is measured. The effective measurement range is 0⁻40 N and 0⁻4 N·M under tension and torque, respectively. Finally, the error of the sensor after calibration and decoupling for Fx is 3.4% and for Tx is 4.2% under a compound test load (35 N and 3.5 N·M). The proposed sensor exhibits the merits of being passive and wireless, and has an ingenious structure. This passive and wireless sensor is useful for the long-term detection of mechanical loading within a moving object, and can even potentially be used for tracing dangerous overloads and for preventing implant failures by monitoring the deformation of implants in the human body.

Osseointegrated Auditory Devices: Bone-Anchored Hearing Aid and PONTO.

Osseointegrated auditory devices (OADs) are hearing devices that use an external receiver/processor that stimulates bone conduction of sound via a titanium prosthesis that is drilled into the bone of the cranium. Since their introduction in 1977, OADs have undergone substantial evolution, including changes in manufacturing of the implant, improvements in the external sound processor, and simplification of implantation techniques. Expansion of criteria for patient candidacy for implantation has occurred corresponding with changes in the implants and processors.

Validation of a Simple Overlay Device to Assess Radial Head Implant Length.

PURPOSE: A simple overlay device (SOD) was developed to measure radial head implant length. The purpose of this study was to determine the accuracy and reliability of this device for measuring experimental radial head implant length. METHODS: Five fresh frozen cadavers were implanted with sequentially longer implants, adjusted by neck length (0, 2, 4, and 8 mm). Fluoroscopic images were obtained in 4 forearm positions: anteroposterior in supination in full extension, anteroposterior in pronation in full extension, supinated in 45° of flexion, and neutral in 45° of flexion. The SOD measurements (made by 2 observers) were compared with the native original radial head (control) to assess implant length. In addition, gapping of the ulnohumeral joint space was measured for comparison purposes. RESULTS: The measured radial head and neck lengths for the specimens were 33, 39, 31, 34, and 42 mm. The difference between the actual radial head and neck lengths and those measured with the SOD template averaged less than 2 mm for all 4 collar sizes, except in 1 measurement in which the bicipital tuberosity could not be visualized. The median intraclass correlation coefficients for observer 1 compared with the SOD were 0.94 to 0.99. The median intraclass correlation coefficients between observers were 0.88 to 0.95. For both observers, elbow position, collar height, and the 2 variables combined did not significantly affect the SOD values. The other method that was evaluated, that of measurement of the ulnohumeral joint space, had higher interobserver variability versus the SOD, and allowed detection of lengthening of over 4 mm. CONCLUSIONS: The SOD is a reliable method for simply assessing radial head length with radiographs and can accurately detect 2 mm or more of proximal radial lengthening. CLINICAL RELEVANCE: The SOD is a simple and accurate method that can help to optimize radial head sizing.

Significant differences between manufacturer and surgeon in the accuracy of final component size prediction with CT-based patient-specific instrumentation for total knee arthroplasty.

PURPOSE: Patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) may improve component sizing. Little has been reported about accuracy of the default plan created by the manufacturer, especially for CT-based PSI. The goal of this study was to evaluate the reliability of this plan and the impact of the surgeon's changes on the final accuracy of the guide sizes. METHODS: Forty-five patients eligible for primary TKA were prospectively enrolled. The planned implant sizes were prospectively recorded from the initial manufacturer's proposal and from the final plan adjusted in light of the surgeon's evaluation; these two sizes where then compared to the actually implanted sizes. Fisher's exact test was used to test differences for categorical variables. Agreement between pre-operative plans and final implant was evaluated with the Bland-Altman method. RESULTS: The manufacturer's proposal differed from the final implant in 9 (20.0%) femoral and 23 (51.1%) tibial components, while the surgeon's plan in 6 (13.3%, femoral) and 12 (26.7%, tibial). Modifications in the pre-operative plan were carried out for five (11.1%) femoral and 23 (51.1%) tibial components (p = 0.03). Appropriate modification occurred in 22 (88.0%) and 19 (76.0%) cases of femoral and tibial changes. The agreement between the manufacturer's and the surgeon's pre-operative plans was poor, especially with regard to tibial components. CONCLUSION: The surgeon's accuracy in predicting the final component size was significantly different from that of the manufacturer and changes in the initial manufacturer's plan were necessary to get an accurate pre-operative plan of the implant sizes. CLINICAL RELEVANCE: Careful evaluation of the initial manufacturer's plan by an experienced knee surgeon is mandatory when planning TKA with CT-based PSI. LEVEL OF EVIDENCE: II.