Clinical Relevance of Posterior Osteophyte Formation in Ultra-congruent Total Knee Arthroplasty: Midterm Radiographic Rollback and Impingement Analysis.

Background: Posterior femoral condylar osteophytes were frequently observed in patients with the ultra-congruent (UC) deep-dish design prosthesis. Therefore, the purpose of the present study was to verify the clinical relevance of osteophyte formation in the UC design. Methods: From March 2014 to February 2018, a comparative study was conducted on 96 knees using the UC design. They were divided into 2 groups (group 1: osteophyte +, group 2: osteophyte -). Intraoperative findings, indirect femoral rollback assessment using 30° flexion and active full flexion lateral radiographs, serial change of the osteophyte, and outcomes were compared. Results: The mean follow-up period was 49.35 ± 3.47 months in group 1 and 47.52 ± 3.37 months in group 2. Posterior component coverage was significantly different between the groups: group 1 exhibited more underhang and group 2 exhibited more overhang (p = 0.022). On the indirect assessment of the femoral rollback, there was a statistically significant difference in deep flexion and change in distance (p < 0.001 and p < 0.001, respectively). There was no statistical difference between the 2 groups in the American Knee Society knee and function score, and group 2 showed significant improvement in pain compared to group 1 in Western Ontario and McMaster University Arthritis Index pain score (p = 0.029). Conclusions: Posterior condylar osteophyte formation was related to posterior impingement. It was more frequently observed in the underhang of the femoral component and insufficient femoral rollback. In addition, it changed with time and caused negative effects, including a gradual decrease in flexion and more pain.

Three-dimensional printed custom-made modular talus prosthesis in patients with talus malignant tumor resection.

BACKGROUND: Talar malignant tumor is extremely rare. Currently, there are several alternative management options for talus malignant tumor including below-knee amputation, tibio-calcaneal arthrodesis, and homogenous bone transplant while their shortcomings limited the clinical application. Three-dimensional (3D) printed total talus prosthesis in talus lesion was reported as a useful method to reconstruct talus, however, most researches are case reports and its clinical effect remains unclear. Therefore, the current study was to explore the application of 3D printed custom-made modular prosthesis in talus malignant tumor. METHODS: We retrospectively analyzed the patients who received the 3D printed custom-made modular prosthesis treatment due to talus malignant tumor in our hospital from February 2016 to December 2021. The patient's clinical data such as oncology outcome, operation time, and volume of blood loss were recorded. The limb function was evaluated with the Musculoskeletal Tumor Society 93 (MSTS-93) score, The American Orthopedic Foot and Ankle Society (AOFAS) score; the ankle joint ranges of motion as well as the leg length discrepancy were evaluated. Plain radiography and Tomosynthesis-Shimadzu Metal Artefact Reduction Technology (T-SMART) were used to evaluate the position of prosthesis and the osseointegration. Postoperative complications were recorded. RESULTS: The average patients' age and the follow-up period were respectively 31.5 ± 13.1 years; and 54.8 months (range 26-72). The medium operation time was 2.4 ± 0.5 h; the intraoperative blood loss was 131.7 ± 121.4 ml. The mean MSTS-93 and AOFAS score was 26.8 and 88.5 respectively. The average plantar flexion, dorsiflexion, varus, and valgus were 32.5, 9.2, 10.8, and 5.8 degree respectively. One patient had delayed postoperative wound healing. There was no leg length discrepancy observed in any patient and good osseointegration was observed on the interface between the bone and talus prosthesis in all subjects. CONCLUSION: The modular structure of the prosthesis developed in this study seems to be convenient for prosthesis implantation and screws distribution. And the combination of solid and porous structure improves the initial stability and promotes bone integration. Therefore, 3D printed custom-made modular talus prosthesis could be an alternative option for talus reconstruction in talus malignant tumor patients.

A Magnetic Actuator Device for Fully Automated Blinking in Total Bidirectional Eyelid Paralysis: First Proof of Concept in a Human Participant.

Purpose: Currently, no solution exists to restore natural eyelid kinematics for patients with complete eyelid paralysis due to loss of function of both the levator palpebrae superioris and orbicularis oculi. These rare cases are prone to complications of chronic exposure keratopathy which may lead to corneal blindness. We hypothesized that magnetic force could be used to fully automate eyelid movement in these cases through the use of eyelid-attached magnets and a spectacle-mounted magnet driven by a programmable motor (motorized magnetic levator prosthesis [MMLP]). Methods: To test this hypothesis and establish proof of concept, we performed a finite element analysis (FEA) for a prototype MMLP to check the eyelid-opening force generated by the device and verified the results with experimental measurements in a volunteer with total bidirectional eyelid paralysis. The subject was then fitted with a prototype to check the performance of the device and its success. Results: With MMLP, eye opening was restored to near normal, and blinking was fully automated in close synchrony with the motor-driven polarity reversal, with full closure on the blink. The device was well tolerated, and the participant was pleased with the comfort and performance. Conclusions: FEA simulation results conformed to the experimentally observed trend, further supporting the proof of concept and design parameters. This is the first viable approach in human patients with proof of concept for complete reanimation of a bidirectionally paretic eyelid. Further study is warranted to refine the prototype and determine the feasibility and safety of prolonged use. Translational Relevance: This is first proof of concept for our device for total bidirectional eyelid paralysis.

Metal-backed or all-poly tibial components: which are better for medial unicompartmental knee arthroplasty? A propensity-score-matching retrospective study at the 5-year follow-up.

BACKGROUND: This retrospective medium-term follow-up study compares the outcomes of medial fixed-bearing unicompartmental knee arthroplasty (mUKA) using a cemented metal-backed (MB) or an all-polyethylene (AP) tibial component. MATERIALS AND METHODS: The database of our institution was mined for primary mUKA patients implanted with an MB or an AP tibial component (the MB-UKA and AP-UKA groups, respectively) from 2015 to 2018. We compared patient demographics, patient-reported outcome measures (PROMs), and motion analysis data obtained with the Riablo™ system (CoRehab, Trento, Italy). We conducted propensity-score-matching (PSM) analysis (1:1) using multiple variables. RESULTS: PSM analysis yielded 77 pairs of MB-UKA and AP-UKA patients. At 5 years, the physical component summary (PCS) score was 52.4 ± 8.3 in MB-UKA and 48.2 ± 8.3 in AP-UKA patients (p < 0.001). The Forgotten Joint Score (FJS-12) was 82.9 ± 18.8 in MB-UKAs and 73.4 ± 22.5 in AP-UKAs (p = 0.015). Tibial pain was reported by 7.8% of the MB-UKA and 35.1% of the AP-UKA patients (p < 0.001). Static postural sway was, respectively, 3.9 ± 2.1 cm and 5.4 ± 2.3 (p = 0.0002), and gait symmetry was, respectively, 92.7% ± 3.7 cm and 90.4% ± 5.4 cm (p = 0.006). Patient satisfaction was 9.2 ± 0.8 in the MB-UKA and 8.3 ± 2.0 in the AP-UKA group (p < 0.003). CONCLUSIONS: MB-UKA patients experienced significantly better 5-year static sway and gait symmetry outcomes than AP-UKA patients. Although the PROMs of the two groups overlapped, MB-UKA patients had a lower incidence of tibial pain, better FJS-12 and PCS scores, and were more satisfied.

Three-Dimensional Printed Total Talus Replacement with a Concurrent Total Ankle Arthroplasty as a Personalized Approach for Advanced Ankle Osteoarthritis A Case Repor.

Ankle arthritis is becoming more common and can be pain-ful and debilitating. As the disease progresses, degenera-tive cystic changes may be found in the distal fibula, distal tibia, and talus. After failure of non-operative modalities, arthrodesis is often considered the surgical intervention of choice, but this leaves the patient with reduced range of motion, altered gait, and can negatively impact adjacent joints of the foot. Total ankle arthroplasty has been found to be an effective surgical option for ankle arthritis but is contraindicated in patients with talar collapse. When this is the case, a more personalized approach for preserving ankle motion is necessary. We present the case of a 65-year-old male with severe right ankle arthritis and talar collapse treated with a custom three-dimensionally printed talus and concurrent total ankle replacement with 2-year follow-up.

Unintended Deformation of Stents During Bifurcation PCI: An OCTOBER Trial Substudy.

BACKGROUND: Unintended deformation of implanted coronary stents can lead to loss of coronary access, stent thrombosis and coronary events during follow-up. The incidence, mechanisms and clinical outcomes of unintended stent deformations (USD) during complex bifurcation stenting are not well characterized. OBJECTIVES: In a prespecified analysis of the OCTOBER (European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction) trial, we aimed to: 1) determine the incidence and characterize mechanisms of USD identified by optical coherence tomography (OCT); and 2) evaluate physician's detection and correction of accidental abluminal rewiring and USD. METHODS: OCT scans were analyzed for accidental abluminal rewiring and USD. When USD was identified, the plausible mechanism was determined by analysis of all procedural OCT scans and the corresponding angiograms. RESULTS: USD was identified by the core lab in 9.3% (55/589) of OCT-guided cases. Accidental abluminal rewiring was the cause in 44% (24/55), and guide catheter collision was the cause in 40% (22/55) of cases. USD was found in 18.5% of all cases with left main bifurcation percutaneous coronary intervention. The total incidence of abluminal rewiring was 33 in 32 OCT-guided cases (5.4%) and was corrected by physicians in 18 of 33 appearances (54.5%). The 2-year major adverse cardiac event rate for patients with untreated USD (n = 30) was 23.3%, whereas patients with confirmed or possibly corrected USD (n = 25) had no events during follow-up. CONCLUSIONS: USD was associated with adverse procedural complications and cardiac events during follow-up when not identified and corrected. The predominant mechanisms were undetected abluminal rewiring and guide catheter collision. Left main bifurcation percutaneous coronary intervention was a particular risk with USD detected in 18.5% of cases.

An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses.

OBJECTIVES: The objective of this analysis was to assess the normal haemodynamic performance of contemporary surgical aortic valves at 1 year postimplant in patients undergoing surgical aortic valve replacement for significant valvular dysfunction. By pooling data from 4 multicentre studies, this study will contribute to a better understanding of the effectiveness of surgical aortic valve replacement procedures, aiding clinicians and researchers in making informed decisions regarding valve selection and patient management. METHODS: Echocardiograms were assessed by a single core laboratory. Effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity and stroke volume were evaluated. RESULTS: The cohort included 2958 patients. Baseline age in the studies ranged from 70.1 ± 9.0 to 83.3 ± 6.4 years, and Society of Thoracic Surgeons risk of mortality was 1.9 ± 0.7 to 7.5 ± 3.4%. Twenty patients who had received a valve model implanted in fewer than 10 cases were excluded. Ten valve models (all tissue valves; n = 2938 patients) were analysed. At 1 year, population mean effective orifice area ranged from 1.46 ± 0.34 to 2.12 ± 0.59 cm2, and dimensionless velocity index, from 0.39 ± 0.07 to 0.56 ± 0.15. The mean gradient ranged from 8.6 ± 3.4 to 16.1 ± 6.2 mmHg with peak aortic velocity of 1.96 ± 0.39 to 2.65 ± 0.47 m/s. Stroke volume was 75.3 ± 19.6 to 89.8 ± 24.3 ml. CONCLUSIONS: This pooled cohort is the largest to date of contemporary surgical aortic valves with echocardiograms analysed by a single core lab. Overall haemodynamic performance at 1 year ranged from good to excellent. These data can serve as a benchmark for other studies and may be useful to evaluate the performance of bioprosthetic surgical valves over time. CLINICAL TRIAL REGISTRATION NUMBER: NCT02088554, NCT02701283, NCT01586910 and NCT01531374.

A multifaceted suite of metrics for comparative myoelectric prosthesis controller research.

Upper limb robotic (myoelectric) prostheses are technologically advanced, but challenging to use. In response, substantial research is being done to develop person-specific prosthesis controllers that can predict a user's intended movements. Most studies that test and compare new controllers rely on simple assessment measures such as task scores (e.g., number of objects moved across a barrier) or duration-based measures (e.g., overall task completion time). These assessment measures, however, fail to capture valuable details about: the quality of device arm movements; whether these movements match users' intentions; the timing of specific wrist and hand control functions; and users' opinions regarding overall device reliability and controller training requirements. In this work, we present a comprehensive and novel suite of myoelectric prosthesis control evaluation metrics that better facilitates analysis of device movement details-spanning measures of task performance, control characteristics, and user experience. As a case example of their use and research viability, we applied these metrics in real-time control experimentation. Here, eight participants without upper limb impairment compared device control offered by a deep learning-based controller (recurrent convolutional neural network-based classification with transfer learning, or RCNN-TL) to that of a commonly used controller (linear discriminant analysis, or LDA). The participants wore a simulated prosthesis and performed complex functional tasks across multiple limb positions. Analysis resulting from our suite of metrics identified 16 instances of a user-facing problem known as the "limb position effect". We determined that RCNN-TL performed the same as or significantly better than LDA in four such problem instances. We also confirmed that transfer learning can minimize user training burden. Overall, this study contributes a multifaceted new suite of control evaluation metrics, along with a guide to their application, for use in research and testing of myoelectric controllers today, and potentially for use in broader rehabilitation technologies of the future.

The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study.

BACKGROUND: The Vega System® PS (Aesculap AG, Tuttlingen, Germany) is an advanced, third generation fixed implant that aims to mimic natural knee kinematics by optimizing pivotal motion while reducing surface stress. This study evaluated mid-term survival and clinical outcomes, including range of motion (ROM) of the modern posterior stabilized implant in order to analyse whether this biomechanically successful implant reaches good results in situ. METHODS: The first 100 patients to receive the Vega PS System for total knee arthroplasty were invited to take part in this single centre, single surgeon study. Of these, 84 patients were clinically assessed 5-6 years postoperatively. Data which was obtained during this follow-up examination included revision data, range of motion and clinical scores. RESULTS: The 5-year survival rate for exchange of any component was 97.6%, whereby two patients required replacement of the polyethylene gliding surface. Secondary patella resurfacing was performed in 7 patients. Significantly improved results in comparison to the preoperative state could be obtained at the follow-up: KOOS improved from 39.4 to 78.8, SF-12 PCS improved from 32.1 to 42 SF-12 MCS improved from 46 to 53.8 and patella pain improved from 2.7 to 0.3. The mean ROM of the 84 patients after 5 years was 133.1° and mean total KSS was 189.9. DISCUSSION & CONCLUSIONS: This study demonstrates a high survival rate of the Vega PS System® and significant improvements in clinical outcomes 5 years after implantation. The obtained mean ROM indicates that this implant provides good flexibility of the knee joint, allowing a high number of activities. However, due to the rate of secondary patella implantation, routine resurfacing of the patella for all PS TKA cases is highly recommended. CLINICAL TRIALS REGISTRATION: The study was registered at clinicaltrials.gov (NCT02802085).

[Outcomes of extended depth of focus intraocular lenses implantation]. / Rezul'tat implantatsii intraokulyarnykh linz s rasshirennoi glubinoi fokusa.

Extended depth of focus (EDOF) intraocular lenses (IOLs) are the latest IOL designs. In recent years, several models of EDOF IOLs have become available in Russia, two of which (Tecnis Symfony and Acrysof IQ Vivity) are implanted in our clinic. Comparative studies devoted to the results of implantation of the new EDOF IOLs are rare in the available literature. PURPOSE: This article compares the outcomes of implantation of two EDOF IOLs in patients with presbyopia and/or cataract. MATERIAL AND METHODS: The prospective study included 60 patients (81 eyes) after implantation of EDOF IOL Tecnis Symfony (32 patients, 45 eyes; group 1) or EDOF IOL AcrySof IQ Vivity (28 patients, 36 eyes; group 2). The mean follow-up period was 3.9±1.3 months. RESULTS: All groups showed a significant (p<0.05) increase in uncorrected near visual acuity (UCNVA), intermediate visual acuity (UCIVA), and distance visual acuity (UCDVA) at the maximum follow-up time compared to preoperative values. In group 1, the best corrected near visual acuity (BCNVA) increased from 0.61±0.10 to 0.82±0.16 at the maximum follow-up time, and in group 2 - from 0.58±0.08 to 0.67±0.12 (p>0.05). Both groups showed a significant increase in best corrected intermediate and distance visual acuity (BCIVA and BCDVA) at the maximum follow-up time. The increase in the indicator compared to the preoperative period was not significant in both groups (p>0.05). The frequency of side optical phenomena was low in both groups. No significant differences were found between the groups (p>0.05). CONCLUSION: This study presents a comparative analysis of the results of implantation of two different EDOF IOLs. Both lenses were comparable in most of the studied parameters, including providing good distance and intermediate vision, functional near vision, as well as a low frequency of side optical phenomena. In all cases the patients were satisfied with the results of the surgical intervention.

Finite element analysis of the effect of tibial osteotomy on the stress of polyethylene liner in total knee arthroplasty.

AIM: To explore the effects of tibial osteotomy varus angle combined with posterior tibial slope (PTS) on the stress of polyethylene liner in total knee arthroplasty (TKA) by building finite element model (FEM). METHODS: Established the FEM of standard TKA with tibial osteotomy varus angle 0° to 9° were established and divided into 10 groups. Next, each group was created 10 FEMs with 0° to 9° PTS separately. Calculated the stress on polyethylene liner in each group in Abaqus. Finally, the relevancy between tibial osteotomy angle and polyethylene liner stress was statistically analyzed using multiple regression analysis. RESULTS: As the varus angle increased, the area of maximum stress gradually shifted medially on the polyethylene liner. As the PTS increases, the percentage of surface contact forces on the medial and lateral compartmental of the polyethylene liner gradually converge to the same. When the varus angle is between 0° and 3°, the maximum stress of the medial compartmental surfaces of polyethylene liner rises smoothly with the increase of the PTS. When the varus angle is between 4° and 9°, as the increase of the PTS, the maximum stress of polyethylene liner rises first and then falls, forming a trough at PTS 5° and then rises again. Compared to the PTS, the varus angle has a large effect on the maximum stress of the polyethylene liner (p < .001). CONCLUSION: When the varus angle is 0° to 3°, PTS 0° is recommended, which will result in a more equalized stress distribution of the polyethylene liner in TKA.

3D-Printed custom-made hemipelvic endoprosthetic reconstruction following periacetabular tumor resection: utilizing a novel classification system.

BACKGROUND: Customized 3D-printed pelvic implants with a porous structure have revolutionized periacetabular pelvic defect reconstruction after tumor resection, offering improved osteointegration, long-term stability, and anatomical fit. However, the lack of an established classification system hampers implementation and progress. METHODS: We formulated a novel classification system based on pelvic defect morphology and 3D-printed hemipelvis endoprostheses. It integrates surgical approach, osteotomy guide plate and prosthesis design, postoperative rehabilitation plans, and perioperative processes. RESULTS: Retrospectively analyzing 60 patients (31 males, 29 females), we classified them into Type A (15 patients: Aa = 6, Ab = 9), Type B (27 patients: Ba = 15, Bb = 12), Type C (17 patients). All underwent customized osteotomy guide plate-assisted tumor resection and 3D-printed hemipelvic endoprosthesis reconstruction. Follow-up duration was median 36.5 ± 15.0 months (range, 6 to 74 months). The mean operating time was 430.0 ± 106.7 min, intraoperative blood loss 2018.3 ± 1305.6 ml, transfusion volume 2510.0 ± 1778.1 ml. Complications occurred in 13 patients (21.7%), including poor wound healing (10.0%), deep prosthesis infection (6.7%), hip dislocation (3.3%), screw fracture (1.7%), and interface loosening (1.7%). VAS score improved from 5.5 ± 1.4 to 1.7 ± 1.3, MSTS-93 score from 14.8 ± 2.5 to 23.0 ± 5.6. Implant osseointegration success rate was 98.5% (128/130), with one Type Ba patient experiencing distal prosthesis loosening. CONCLUSION: The West China classification may supplement the Enneking and Dunham classification, enhancing interdisciplinary communication and surgical outcomes. However, further validation and wider adoption are required to confirm clinical effectiveness.

An adaptive prosthetic socket for people with transtibial amputation.

It is essential that people with limb amputation maintain proper prosthetic socket fit to prevent injury. Monitoring and adjusting socket fit, for example by removing the prosthesis to add prosthetic socks, is burdensome and can adversely affect users' function and quality-of-life. This study presents results from take-home testing of a motor-driven adaptive socket that automatically adjusted socket size during walking. A socket fit metric was calculated from inductive sensor measurements of the distance between the elastomeric liner surrounding the residual limb and the socket's inner surface. A proportional-integral controller was implemented to adjust socket size. When tested on 12 participants with transtibial amputation, the controller was active a mean of 68% of the walking time. In general, participants who walked more than 20 min/day demonstrated greater activity, less doff time, and fewer manual socket size adjustments for the adaptive socket compared with a locked non-adjustable socket and a motor-driven socket that participants adjusted with a smartphone application. Nine of 12 participants reported that they would use a motor-driven adjustable socket if it were available as it would limit their socket fit issues. The size and weight of the adaptive socket were considered the most important variables to improve.

Biodegradable tracheal stents: our ten-year experience with adult patients.

BACKGROUND: Biodegradable (BD) stents made from polydioxanone have been used only in human airways. These stents combine the advantages of classical tracheal stents, and fewer side effects are expected due to their biocompatibility and their time-limited presence in airways. However, new clinical consequences have arisen. Here, the authors share their experiences with BD stents for tracheal indications, focusing on their safety and efficacy. METHODS: This was a retrospective review of a collected database of adult patients who underwent implantation of biodegradable tracheal stents between September 2013 and December 2022 at the Department of Respiratory Medicine of the 1st Faculty of Medicine in Prague and Thomayer University Hospital. The indications included functionally significant nonmalignant tracheal stenosis and tracheomalacia. Self-expandable, biodegradable, polydioxanone tracheal stents manufactured by ELLA-CS Ltd. (Hradec Kralove, Czech Republic) were implanted during rigid bronchoscopy under general anaesthesia. All patients were followed up in the department and were provided with the necessary care. The main efficacy and safety parameters and relationships were analysed using descriptive statistics and Fisher´s exact, Wilcoxon and Kruskal‒Wallis tests. RESULTS: A total of 65 stents were implanted in 47 adult patients. During the first two months after implantation, when adequate function was expected, the stent was found to be effective in 26 out of 39 patients who completed this period (66.7%). The clinical effectiveness reached 89.7%, as early restenoses were mostly mild and necessitated treatment in only 4 patients. The frequencies of significant mucostasis, migration and granulation tissue growth were 2.6%, 7.5% and 23.1%, respectively, during this period. Thirty-four participants completed the half-year follow-up period after the first or second stent insertion, and some were followed up beyond this period. Poor control of symptoms, the development of restenosis and the need for interventions were characteristic of this period as the stents degraded. Twenty-two patients who experienced remodelling or stabilization of the tracheal lumen achieved a stent-free state. Seven patients underwent subsequent surgical treatment. CONCLUSIONS: BD stents are safe and provide adequate tracheal support until they begin to degrade. The use of BD stents necessitates close monitoring of patients and accurate treatment of possible restenosis. TRIAL REGISTRATION: Based on project NT14146 - Biodegradable stents in the management of the large airways (2013-2015, MZ0/NT), registered on May 1, 2013, in the Research and Development and Innovation Information System of the Czech Republic and at ClinicalTrials.gov (reg. no. NCT02620319, December 2, 2015).