Three-Dimensional Auricular Subunit Models for Cartilage Framework Fabrication: Our Preliminary Experience.

BACKGROUND: Three-dimensional (3D) digital imaging and printing techniques have been popularly applied in microtia reconstruction. However, there is a lack of clinical report of using them to create 3D printed ear subunit models for cartilage framework fabrication. METHODS: A retrospective study of patients who underwent auricle reconstruction with 3D templates was performed. Patients' demography, surgical complications, framework accuracy, and aesthetic outcomes of the reconstructed auricles were analyzed. RESULTS: Twenty cases included in this study. Complications were minor. The average (median) assessing scores for the framework quality and the reconstructed auricle aesthetics were 8.50 (8) and 8.30 (8), respectively. CONCLUSIONS: Our study found that the use of custom-printed tridimensional ear subunit models achieved a relatively high framework precision and gained good outcomes of the reconstructed ears.Level of Evidence: Level IV.

Additional use of anti-rotation U-blade (RC) decreases lag screw sliding and limb length inequality in the treatment of intertrochanteric fractures.

The purpose of this study is to compare the cut-out rate and sliding distance associated with limb length inequality between operations using a standard non-sliding lag screw versus those using a non-sliding lag screw with U-blade (RC) in the Gamma3 nail. This is a retrospective review of two case series involving different lag screws for the Gamma3 nail. Propensity score matching analysis was used to adjust the confounding factors. A comparative analysis of 304 patients who treated with Gamma3 nail with either a standard non-sliding lag screw or a U-Blade (RC) lag screw was performed. Between 2014 and 2018, 152 patients were treated with U-blade (RC) lag screws, and these patients were matched with those treated with standard lag screws. There was no significant difference in cut-out rate between groups. However, additional use of anti-rotation U-blade (RC) could significantly decrease lag screw sliding, with the group treated with U-Blade (RC) lag screws exhibiting shorter sliding, especially in AO/OTA31 A2 and A3 fractures. Also, in A2 and A3 fractures, the mean lag screw sliding distance was greater than that seen in A1 fractures in both groups. These findings can help trauma surgeons choose the proper implant to reduce leg length inequality.

Testing silicone digit extensions as a way to suppress natural sensation to evaluate supplementary tactile feedback.

Dexterous use of the hands depends critically on sensory feedback, so it is generally agreed that functional supplementary feedback would greatly improve the use of hand prostheses. Much research still focuses on improving non-invasive feedback that could potentially become available to all prosthesis users. However, few studies on supplementary tactile feedback for hand prostheses demonstrated a functional benefit. We suggest that confounding factors impede accurate assessment of feedback, e.g., testing non-amputee participants that inevitably focus intently on learning EMG control, the EMG's susceptibility to noise and delays, and the limited dexterity of hand prostheses. In an attempt to assess the effect of feedback free from these constraints, we used silicone digit extensions to suppress natural tactile feedback from the fingertips and thus used the tactile feedback-deprived human hand as an approximation of an ideal feed-forward tool. Our non-amputee participants wore the extensions and performed a simple pick-and-lift task with known weight, followed by a more difficult pick-and-lift task with changing weight. They then repeated these tasks with one of three kinds of audio feedback. The tests were repeated over three days. We also conducted a similar experiment on a person with severe sensory neuropathy to test the feedback without the extensions. Furthermore, we used a questionnaire based on the NASA Task Load Index to gauge the subjective experience. Unexpectedly, we did not find any meaningful differences between the feedback groups, neither in the objective nor the subjective measurements. It is possible that the digit extensions did not fully suppress sensation, but since the participant with impaired sensation also did not improve with the supplementary feedback, we conclude that the feedback failed to provide relevant grasping information in our experiments. The study highlights the complex interaction between task, feedback variable, feedback delivery, and control, which seemingly rendered even rich, high-bandwidth acoustic feedback redundant, despite substantial sensory impairment.

Three-dimensional printing-based personalized limb salvage and reconstruction treatment of pelvic tumors.

BACKGROUND AND OBJECTIVES: The treatment of pelvic tumors is widely recognized to be challenging. The purpose of this study was to evaluate the efficacy of personalized three-dimensional (3D) printing-based limb salvage and reconstruction treatment for pelvic tumors. METHODS: Twenty-eight pelvic tumor patients were enrolled. 3D printing lesion models and osteotomy templates were prepared for surgery planning, prosthesis design, and osteotomy assistance during surgery. 3D printing-based personalized pelvic prostheses were manufactured and used in all 28 patients. Follow-up of postoperative survival, prosthesis survival, imaging examinations, and Musculoskeletal Tumor Society (MSTS) lower limb functional scores were carried out. RESULTS: The mean follow-up period was 32.2 months, during which 16 patients had disease-free survival, 3 survived with the disease, and 9 died. The prostheses were stable, and the mean offset of the center of rotation was 5.48 mm. The prosthesis-bone interface showed good integration. For the 19 surviving patients, the mean MSTS lower limb functional score was 23.2. Postoperative complications included superficial infection in six patients and hip dislocation in three patients. CONCLUSIONS: Personalized 3D printing-based limb salvage and reconstruction was an effective treatment for pelvic tumors. Our patients achieved good early postoperative efficacy and functional recovery.

Clinical evaluation of the revolutionizing prosthetics modular prosthetic limb system for upper extremity amputees.

Individuals with upper extremity (UE) amputation abandon prostheses due to challenges with significant device weight-particularly among myoelectric prostheses-and limited device dexterity, durability, and reliability among both myoelectric and body-powered prostheses. The Modular Prosthetic Limb (MPL) system couples an advanced UE prosthesis with a pattern recognition paradigm for intuitive, non-invasive prosthetic control. Pattern recognition accuracy and functional assessment-Box & Blocks (BB), Jebsen-Taylor Hand Function Test (JHFT), and Assessment of Capacity for Myoelectric Control (ACMC)-scores comprised the main outcomes. 10 participants were included in analyses, including seven individuals with traumatic amputation, two individuals with congenital limb absence, and one with amputation secondary to malignancy. The average (SD) time since limb loss, excluding congenital participants, was 85.9 (59.5) months. Participants controlled an average of eight motion classes compared to three with their conventional prostheses. All participants made continuous improvements in motion classifier accuracy, pathway completion efficiency, and MPL manipulation. BB and JHFT improvements were not statistically significant. ACMC performance improved for all participants, with mean (SD) scores of 162.6 (105.3), 213.4 (196.2), and 383.2 (154.3), p = 0.02 between the baseline, midpoint, and exit assessments, respectively. Feedback included lengthening the training period to further improve motion classifier accuracy and MPL control. The MPL has potential to restore functionality to individuals with acquired or congenital UE loss.

From Patient to Procedure: The Process of Creating a Custom 3D-Printed Medical Device for Foot and Ankle Pathology.

Three-dimensional (3D) printing technology has advanced greatly over the past decade and is being used extensively throughout the field of medicine. Several orthopaedic surgery specialties have demonstrated that 3D printing technology can improve patient care and physician education. Foot and ankle pathology can be complex as the 3D anatomy can be challenging to appreciate. Deformity can occur in several planes simultaneously and bone defects either from previous surgery or trauma can further complicate surgical correction. Three-dimensional printing technology provides an avenue to tackle the challenges associated with complex foot and ankle pathology. A basic understanding of how these implants are designed and made is important for surgeons as this technology is becoming more widespread and the clinical applications continue to grow within foot and ankle surgery.Levels of Evidence: Level V.

Promising results of revision total hip arthroplasty using a hexagonal, modular, tapered stem in cases of aseptic loosening.

BACKGROUND: Modular stems are widely used in revision total hip arthroplasty (THA) with aseptic loosening being a common reason for revision. Despite the good results reported on the use of modular stem designs, there are only few studies focusing on aseptic revisions and few studies on a hexagonal stem design. The goal of this study is to determine stem survival, clinical and functional outcome along with possible risk factors for implant failure in aseptic revision THA. METHODS: We retrospectively identified 53 patients with aseptic THA revision using a modular hexagonal stem with a minimum follow-up of two years. Femoral bone loss, radiographic and clinical outcomes as well as function measured using the Harris Hip Score (HHS) was assessed. Patients' previous medical history was analyzed for comorbidities and the body mass index. Stem survival was calculated using the Kaplan-Meier method. Possible risk factors for implant failure were analyzed using the log-rank test. The median age at revision was 69 (IQR 62-73) with a median follow up of 74 months. RESULTS: Implant survival rates amounted to 90.4% at 3 and 5 years. The median HHS improved by 47 points (34 (IQR 22-47) vs 81 (IQR 59-90) p<0.001). There was a reduced implant survival after 5 years when the revision stem was used following a previous cemented stem (83.4% vs 100%, p = 0.04). CONCLUSION: A modular, hexagonal stem can be successfully used in aseptic revision THA with remarkable functional results and excellent survivorship. Revision of a cemented stem using this implant might result in reduced survival which must be considered when planning treatment.

Customised three-dimensional printed revision acetabular implant for large defect after failed triflange revision cup.

Aseptic loosening is the most common cause for total hip arthroplasty revision. Acetabular cup revision is a significant challenge in the presence of a large bone defect. One of the options for cup revision in the presence of a large bone defect is the recently introduced customised three-dimensional (3D)-printed reconstruction. We present the case of a 68-year-old woman successfully treated with a customised revision acetabular implant for the failure of triflange cup in the presence of large acetabular defect. The modern orthopaedic surgeon must have full knowledge of customised 3D-printed reconstruction to have as a reserve solution for difficult hip revision surgery.

Locally coupled electromechanical interfaces based on cytoadhesion-inspired hybrids to identify muscular excitation-contraction signatures.

Coupling myoelectric and mechanical signals during voluntary muscle contraction is paramount in human-machine interactions. Spatiotemporal differences in the two signals intrinsically arise from the muscular excitation-contraction process; however, current methods fail to deliver local electromechanical coupling of the process. Here we present the locally coupled electromechanical interface based on a quadra-layered ionotronic hybrid (named as CoupOn) that mimics the transmembrane cytoadhesion architecture. CoupOn simultaneously monitors mechanical strains with a gauge factor of ~34 and surface electromyogram with a signal-to-noise ratio of 32.2 dB. The resolved excitation-contraction signatures of forearm flexor muscles can recognize flexions of different fingers, hand grips of varying strength, and nervous and metabolic muscle fatigue. The orthogonal correlation of hand grip strength with speed is further exploited to manipulate robotic hands for recapitulating corresponding gesture dynamics. It can be envisioned that such locally coupled electromechanical interfaces would endow cyber-human interactions with unprecedented robustness and dexterity.

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.

A custom, functional and lifelike passive prosthetic hand for infants and small toddlers: Clinical note.

BACKGROUND AND AIM: For infants and small toddlers with congenital upper limb deficiencies, terminal devices mainly provide either cosmesis or functionality. We report a clinical note about fitting a child with a low-cost passive hand targeting both functionality and cosmesis. TECHNIQUE: An elastomeric, alloy-wire-reinforced hand was fabricated using additive manufacturing to allow independent positioning of the digits. A clinical pilot in-home evaluation was conducted on a child with upper limb loss. DISCUSSION: The fabricated hand met the functional requirements but required a cover for cosmesis due to a poor surface finish associated with the fabrication technique. The participant child was comfortable using the prosthesis for various tasks. The parents were satisfied with the hand's function and cosmesis when covered with a cosmetic glove. This work demonstrated a new design and process that may in the future improve the utilization of prosthetic hands to promote early prosthesis use and a child's development. CLINICAL RELEVANCE: Early prosthesis use is important for infants and toddlers. Additive manufacturing may enable the fabrication of custom passive prosthetic hands that provide both cosmesis and functionality.

The utility of the single-subject method for comparison of temporal-spatial gait changes between a microprocessor and non-microprocessor prosthetic knees.

BACKGROUND: Despite increasing knowledge about the potential benefits of advanced user-controlled technology, the decision about switching an individual prosthesis user from a non-microprocessor prosthetic knee to a microprocessor prosthetic knee is mainly based on clinician's experience rather than empirical evidence. OBJECTIVES: To demonstrate the utility of single-subject design and data analysis for evaluating changes in temporal-spatial gait characteristics between walking with a non-microprocessor prosthetic knee and microprocessor prosthetic knee. STUDY DESIGN: Single-subject ABA/BAB design. METHODS: Seven non-microprocessor prosthetic knee users (all men, age 50-84 years, 3-40 years post-amputation) were transitioned through the ABA or BAB phases (A-NMPK, B-MPK, 5 weeks each). Four weekly gait evaluations were performed at three self-selected speeds with an electronic walkway. The non-microprocessor prosthetic knee-microprocessor prosthetic knee differences in stride length-cadence relationship, prosthetic weight acceptance, single-limb support, and step width were evaluated for each subject using the "non-overlap of all pairs" statistical method. RESULTS: Most subjects improved temporal-spatial gait while on the microprocessor prosthetic knee; in only one subject, none of the 10 gait parameters were in favor of the microprocessor prosthetic knee. In the BAB group, longer use of the microprocessor prosthetic knee was associated with shorter prosthetic weight acceptance and longer single-limb support times across three speeds. Step width either improved with the microprocessor prosthetic knee or remained unchanged in most subjects. CONCLUSION: The evidence of individual subject improvements in gait coordination, greater reliance on the prosthetic side, and better stability with the microprocessor prosthetic knee than non-microprocessor prosthetic knee over a range of walking speeds demonstrate the practical utility of the single-subject method in clinical decision-making. CLINICAL RELEVANCE: The results demonstrate the use of the single-subject method for examining person-specific differences in temporal-spatial gait characteristics between walking with a non-microprocessor prosthetic knee and microprocessor prosthetic knee at three self-selected speeds. The method proved feasible and reliable for documenting changes in gait at the individual level, which is relevant for clinical practice.

Ten-Year Outcomes of Total Hip Arthroplasty Using Fit-and-Fill Type Cementless Collared Straight Stem Implants: Relationship between the Initial Contact Status and Stress Shielding.

We investigated the relationship between the initial contact status and stress shielding in total hip arthroplasty (THA) using fit-and-fill type straight-stem implants. In addition we evaluated the clinical and radiographic outcomes. Subjects were 100 hips of 94 patients who underwent THA and were followed-up for ≥10 years. Contact areas with the femoral cortical bone were investigated according to the zonal distribution of Gruen using postoperative CT images. Depending on the number of contact areas, the patients were classified into high contact [HC], medium contact [MC], and low contact [LC] groups. Radiographic and clinical outcomes were evaluated. In the HC group (20 hips), severe stress shielding was observed in 12 hips, which was statistically significant (p=0.008). In the LC group (29 hips), mild stress shielding was observed in 27 hips which was statistically significant (p<0.001). No significant differences were observed among the 3 groups in clinical outcomes, Harris hip score (p=0.719) or Japanese Orthopedic Association (JOA) score (p=0.301). In insertion of cementless collared fit-and-fill type straight-stem implants, severe late stress shielding of the femoral bone may occur if high contact of the femoral component is achieved. However, the degree of stress shielding does not result in adverse clinical outcomes.

Fluidic Haptic Interface for Mechano-Tactile Feedback.

Notable advancements have been achieved in providing amputees with sensation through invasive and non-invasive haptic feedback systems such as mechano-, vibro-, electro-tactile and hybrid systems. Purely mechanical-driven feedback approaches, however, have been little explored. In this paper, we now created a haptic feedback system that does not require any external power source (such as batteries) or other electronic components (see Fig. 1 ). The system is low-cost, lightweight, adaptable and robust against external impact (such as water). Hence, it will be sustainable in many aspects. We have made use of latest multi-material 3D printing technology (Stratasys Objet500 Connex3) being able to fabricate a soft sensor and a mechano-tactile feedback actuator made of a rubber (TangoBlack Plus) and plastic (VeroClear) material. When forces are applied to the fingertip sensor, fluidic pressure inside the system acts on the membrane of the feedback actuator resulting in mechano-tactile sensation. Our [Formula: see text] feedback actuator is able to transmit a force range between 0.2 N (the median touch threshold) and 2.1 N (the maximum force transmitted by the feedback actuator at a 3 mm indentation) corresponding to force range exerted to the fingertip sensor of 1.2-18.49 N.

A smartphone-enabled wireless and batteryless implantable blood flow sensor for remote monitoring of prosthetic heart valve function.

Aortic valve disease is one of the leading forms of complications in the cardiovascular system. The failing native aortic valve is routinely surgically replaced with a bioprosthesis. However, insufficient durability of bioprosthetic heart valves often requires reintervention. Valve degradation can be assessed by an analysis of the blood flow characteristics downstream of the valve. This is cost and labor intensive using clinical methodologies and is performed infrequently. The integration of consumer smartphones and implantable blood flow sensors into the data acquisition chain facilitates remote management of patients that is not limited by access to clinical facilities. This article describes the characteristics of an implantable magnetic blood flow sensor which was optimized for small size and low power consumption to allow for batteryless operation. The data is wirelessly transmitted to the patient's smartphone for in-depth processing. Tests using three different experimental setups confirmed that wireless and batteryless blood flow recording using a magnetic flow meter technique is feasible and that the sensor system is capable of monitoring the characteristic flow downstream of the valve.

Pilot study of the microprocessor-controlled prosthetic knee with a novel hydraulic damper.

BACKGROUND: A prosthetic knee is the key component of the transfemoral prosthesis. The performance of the prosthetic knee determines the walking ability of transfemoral amputees. OBJECTIVE: This study proposes a microprocessor-controlled prosthetic knee with a novel hydraulic damper and evaluates the performance of the prosthetic knee by gait symmetry index. METHODS: The homotaxial knee joint with electrical-controlled hydraulic cylinder which adjusts knee flexion and extension damping independently and continuously by single motor was designed. Gait symmetry tests under different walking speeds (0.6 m/s, 1.1 m/s and 1.6 m/s) were conducted to evaluate the performance of the proposed microprocessor-controlled prosthetic knee. RESULTS: The symmetry index values indicated that the stance phase was more asymmetry than swing phase. In the swing phase, the knee angle symmetry was observed in different speeds. The number values of symmetry index were smaller than 15% in swing phase. CONCLUSIONS: The proposed microprocessor-controlled prosthetic knee could meet the demands of walking.

Lumbar Arthroplasty: Past, Present, and Future.

Lumbar degenerative disc disease is a pathologic process that affects a large portion of our aging population. In the recent past, surgical treatment has involved fusion procedures. However, lumbar disc arthroplasty and replacement provides an alternative for carefully selected patients. It provides the major advantage of motion preservation and thus keeps adjacent segments from significantly progressive degeneration. The history of lumbar disc replacement has roots that start in the 1960s with the implantation of stainless-steel balls. Decades later, multiple implants with different material design and biomechanical properties were introduced to the market. New third-generation implants have made great strides in improved biomechanics and clinical outcomes. Although there is room for further advancement and studies are warranted to assess the long-term durability and sustainability of lumbar disc arthroplasty, it has certainly proven to be a very acceptable alternative within the surgical armamentarium that should be offered to patients who meet indications. In this review we present an overview of lumbar disc arthroplasty including its history, indications, biomechanics, challenges, and future directions.

Perception and control of low cable operation forces in voluntary closing body-powered upper-limb prostheses.

Operating a body-powered prosthesis can be painful and tiring due to high cable operation forces, illustrating that low cable operation forces are a desirable design property for body-powered prostheses. However, lower operation forces might negatively affect controllability and force perception, which is plausible but not known. This study aims to quantify the accuracy of cable force perception and control for body-powered prostheses in a low cable operation force range by utilizing isometric and dynamic force reproduction experiments. Twenty-five subjects with trans-radial absence conducted two force reproduction tasks; first an isometric task of reproducing 10, 15, 20, 25, 30 or 40 N and second a force reproduction task of 10 and 20 N, for cable excursions of 10, 20, 40, 60 and 80 mm. Task performance was quantified by the force reproduction error and the variability in the generated force. The results of the isometric experiment demonstrated that increasing force levels enlarge the force variability, but do not influence the force reproduction error for the tested force range. The second experiment showed that increased cable excursions resulted in a decreased force reproduction error, for both tested force levels, whereas the force variability remained unchanged. In conclusion, the design recommendations for voluntary closing body-powered prostheses suggested by this study are to minimize cable operation forces: this does not affect force reproduction error but does reduce force variability. Furthermore, increased cable excursions facilitate users with additional information to meet a target force more accurately.

Implant Design and the Anchoring Mechanism Influence the Incidence of Heterotopic Ossification in Cervical Total Disc Replacement at 2-year Follow-up.

STUDY DESIGN: A nonrandomized, prospective, and single-center clinical trial. OBJECTIVE: The aim of this study was to determine whether the prosthesis design, and especially changes in the primary anchoring mechanism between the keel-based ProDisc C and the spike-based ProDisc Vivo, affects the frequency of heterotopic ossification (HO) formation over time. SUMMARY OF BACKGROUND DATA: The occurrence of motion-restricting HO as well as underlying risk factors has so far been a widely discussed, but not well understand phenomenon. The anchoring mechanism and the opening of the anterior cortex may be possible causes of this unwanted complication. METHODS: Forty consecutive patients treated with the ProDisc C and 42 consecutive patients treated with the ProDisc Vivo were compared with respect to radiological and clinical outcome, with 2 years of follow-up. Clinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and arm and neck pain self-assessment questionnaires. Radiological outcomes included the segmental lordosis and range of motion (ROM) of the index-segment as well as the occurrence of HO. RESULTS: The clinical outcome parameters improved in both groups significantly. [ProDisc C: VAS arm and neck pain from 6.3 and 6.2 preoperatively to 0.7 and 1.3; NDI from 23.0 to 3.7; ProDisc Vivo: VAS arm and neck pain from 6.3 and 4.9 to 1.4 and 1.6, NDI from 34.1 to 8.7; 2-year follow-up (FU)]. The ProDisc Vivo cohort demonstrated a significantly lower incidence of HO than the ProDisc C group at 1-year FU (P = 0.0005) and 2-year FU (P = 0.005). Specifically, high-grade HO occurred in 9% versus 31%. CONCLUSION: These findings demonstrate that prosthesis designs that allow primary anchoring without violation of the cortical surface help to reduce the incidence of severe ossification, possibly affecting the functionality and mobility of the artificial disc device over of time. LEVEL OF EVIDENCE: 3.