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Purpose Some data indicate that first-generation highly cross-linked polyethylene (HXLPE) can oxidise in vivo and is associated with reduced mechanical properties. To overcome these limitations, a natural anti-oxidant vitamin E has been added to HXLPE to preserve the mechanical properties and decrease oxidative degradation whilst conserving high wear resistance. We hypothesised that after a minimal three years of follow-up the use of vitamin E-blended HXLPE would result in lower radiographic wear when compared with ultra-high molecular weight polyethylene (UHMWPE). Methods One hundred patients were randomised to receive hybrid total hip arthroplasty (THA) using a monoblock cementless acetabular component made either of UHMWPE or vitamin E-blended HXLPE. All other parameters were identical in both groups. Complete follow-up was available for 74 of these patients. Femoral head penetration was measured using a validated computer-assisted method. Results The median creep measured 0.111 mm (range, −0.576 – +0.444 mm) in the vitamin E-blended group versus 0.170 mm (range, −0.861 – +0.884 mm) in the UHMWPE group (difference of medians, 0.059; p  = 0.046). The median steady state penetration rate was −0.008 mm/year (range, −0.88 – +0.64 mm/year) in the vitamin E-blended group versus 0.133 mm/year (range, −0.84 – +0.85 mm/year) in the UHMWPE group (difference of medians 0.141, p  = 0.043). Conclusions This study demonstrated that femoral head penetration was lower when using vitamin E-blended HXLPE when compared with UHMWPE, with a steady-state penetration rate far below the osteolysis threshold. Longer-term follow-up is needed to warrant whether wear reduction will generate less occurrence of osteolysis and aseptic loosening.

This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation. 60 thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator. The experimental results showed that the highest number of pedicle screw successfully inserted by the first time was in group C, while lowest in group A ( P  < 0.05). The total time of fluoroscopy and operation were lower in group C, and higher in group A ( P  < 0.05). VAS and ODI scores were all lower after surgery than before surgery in 3groups. VAS and ODI scores were lower in group B and C, compared with group A at day 1, 7 after surgery ( P  < 0.05). KA decreased significantly in 3 groups after surgery and no difference in KA change between 3 groups ( P  > 0.05). Taken together, Application of the 3D printing guide template in combination with pointed lotus-style regulator improved the accuracy of pedicle insertion. Trial registration: ClinicalTrials.gov Identifier: NCT04980131. Registered 18/07/2021.

A triple-armed, double-blind randomized controlled trial with cross-over design investigated patient-reported satisfaction and objective dental evaluation of a 3-unit, monolithic zirconium dioxide (ZrO2), implant-supported fixed dental prosthesis (iFDP) fabricated with 2 completely digital workflows and 1 mixed analog-digital workflow. Participants enrolled required rehabilitation of 2 dental implants in posterior region of either of the arches with a 3-unit, ZrO2 iFDP. A total of 20 participants received the 3 types of ZrO2, iFDP fabricated by 3 different methods. Thus, a total of 60 iFDPs were fabricated in the study. 20 iFDP were fabricated by complete digital workflow by using 3Shape Trios 3 Intraoral scanner (IOS) and 3 Shape designing software (Test-1). In second group (Test-2) 20 iFDPs were fabricated by using Dental Wings Virtuo Vivo IOS and Dental Wings original software (DWOS) for CAD designing. 20 iFDPs (control) were fabricated by mixed analogue-digital workflow by using Polyether impression and Exocad Lab software. The primary clinical outcome was blinded, subjective evaluation on visual analogue scale (VAS) by the participant, and an objective evaluation on VAS by a dentist at the time of prosthetic try-in of each of the 3 types of prosthesis. Secondary outcome was patients' perception about the impression procedures in the 3 different workflows on VAS. The study was conducted at 2 instances during the prosthetic rehabilitation. The primary outcomes were assessed at the time of prosthetic try-in. The secondary outcome was observed after the impression session. Clinical parameters were measured on VAS from 0 to 100 score. For the primary outcome, VAS score was recorded for each iFDP as observed for patient perception (satisfaction) and dentist evaluation (objective). The perception about impression was also recorded on VAS. Descriptive analysis of all scores was done by mean and standard deviation. ANOVA test was used for comparisons among the 3 different types of iFDP. Tukey's HSD was used for pairwise comparisons within ANOVA. Linear regression analyses was done to compare overall satisfaction of the patients and the dentist within each group. The level of significance was set at α = 0.05. After the start of recruitment in January 2020, there were no losses and exclusions. VAS for patient satisfaction was higher than VAS for dentist evaluation. Patient satisfaction among Test-1, Test-2, and Control showed no significant difference (P = 0.876). Dentist satisfaction among workflows were also not significantly different (P = 0.22). The relationship between VAS scores of patients and dentists was weak for Test-1 (R-value = -0.424, P = 0.062), Test-2 (R-value = 0.116, P = 0.068), and Control (R-value = -0.183, P = 0.441). Significant differences for patients' perceptions related to the treatment time for impression procedure (P = 0.005), convenience of impression procedure (P < 0.001), bad oral taste with the impression procedure (P < 0.001), and nausea with the impression procedure (P < 0.001) were observed. Subjective patient satisfaction was similar when comparing iFDPs fabricated with 3 different workflows. Objective dentist evaluation was also similar when comparing the 3 types of iFDPs. However, patient satisfaction of the workflow was higher than dentist evaluation, although there was no correlation between the two. Lower VAS in dentist's evaluation has been attributed to strict standardized clinical criteria and critical expert view. The study also reveals that patients have a favorable perception and preference in favor of digital impressions as compared to use of elastomeric impression materials.

Capsular outcomes of anterior/posterior capsulorhexis opening (ACO/PCO) are essential for performing a secondary in-the-bag intraocular lens implantation. To compare the capsular outcomes with different primary capsulorhexis sizes, Thirty-eight eligible patients (45 eyes) were randomly assigned to three groups by anterior capsulorhexis diameter (Group A: 3.0–3.9, Group B: 4.0–5.0 and Group C: 5.1–6.0 mm). The areas of ACO/PCO and posterior capsule opening opacity (PCOO) as primary outcomes, while, the incidence of visual axis opacity (VAO) as secondary outcome were measured at follow-up visits. Among the thirty eyes included in the final analysis, the mean area of the ACO decreased significantly, whereas the PCO enlarged with time. Group A had the highest anterior capsule constriction and percentage reduction, which increased with time. There were significant differences in the percentage reductions at 6 months and 1 year compared to 1 month in Group A and B. Group C had the highest posterior capsule enlargement. The percentage of PCOO to PCO area and the incidence of VAO was highest in Group A and lowest in Group C. Thus, Capsulorhexis diameter of 4.0–5.0 mm may yield better capsular outcomes, considering moderate contraction of ACO, moderate enlargement of PCO and lower percentage of PCOO and VAO.

The primary objective of this study is to investigate whether a novel prosthetic foot with a polycentric ankle, which offers side-to-side adaptability, improves mobility and daily performance in individuals with (1) unilateral above-knee amputation, (2) unilateral below-knee amputation with a lower mobility level (K2) , or (3) bilateral amputation, any level of amputation. Traditional prostheses are primarily designed for forward walking and lack adaptability for navigating uneven terrain, turning, and executing other multidirectional tasks, often resulting in pain, instability, and limited function. The objective of this testing protocol is to better understand the functional impact of a novel foot design that offers more inversion/eversion rotation of the polycentric ankle. Although the foot has the potential to address mobility challenges, it is unknown whether people with different amputations and mobility levels respond differently. The study includes community-based mobility assessments, standardized questionnaires, and participant feedback. Although side-to-side adaptability prosthetic feet have shown benefits for highly active users, this study aims to evaluate the impact on individuals with more significant mobility limitations. Results may guide prosthetic prescription, expand access to advanced prosthetic technology, and inform reimbursement policies, particularly benefiting veterans and service members with combat-related amputations. The study began recruiting in October 2023; as of September 2025, there were 66 participants (17 below the knee, 34 above the knee, and 15 bilateral) who completed the protocol. The clinical trial is expected to be completed by March 2027. Dissemination of results is expected to be completed by December 2027. This procedural study presents a model for evaluating prosthetic feet and other mobility-assistive technologies in real-world contexts, supporting broader efforts to match components to user needs through clinical trials that are grounded in both functional performance and user experience.

Key Points Demonstrates the difficulties of matching teeth and the need for an objective and reliable means of shade matching. Digital images acquired under standard lighting conditions can provide reliable colour measurements. The use of digital images in shade matching will allow technicians to view variations in tooth colour and improve communication between technicians and clinicians. Objective To develop a shade matching method based on digital imaging and to compare observers' ability using this method with the conventional one set against a spectrophotometric 'gold standard'. Methods Two Vita Lumin shade guides were used in this study, nine shades being selected from the first Vita Lumin shade guide, A2, A3, A3.5, B2, B3, B4, C1, C2 and C3. A second shade guide was used to match the selected shades. A Nikon Coolpix 990 digital camera with Nikon SB21B ring flash was used to record the digital images of the shade tabs of the two shade guides and the images were processed using Adobe Photoshop software. A total of 27 samples (three replicates of each shade of the nine tabs selected) were matched with a digital shade guide prepared from the digital images of the second shade guide by 10 observers on a computer screen (computerised matching method). The 10 observers also matched the same shade tabs using the conventional matching method simulated in a phantom head. In addition, colour values were obtained from the digital images using Adobe Photoshop and quantified according to an internationally recognised scale as CIELAB colour values, L * ,a * ,b * . The relationship of the digitally derived CIELAB values to the CIELAB values obtained using a reflectance spectrophotometer was investigated. Results The cross tabulation statistical analysis showed a statistically significant difference (p<0.001) between the conventional method and the computer method with a 43% and 61.1% correct match respectively. There was also a statistically significant difference between observers in both methods (p<0.001 and p<0.04 for the conventional and computer methods respectively). A statistically significant high correlation of the CIELAB colour values were found between both colour measurement methods (p<0.001). Conclusion The observers' shade matching performance was significantly better with the computer method compared with the conventional one. There was a large variation in the observers' matching ability. The digital camera can be used as a means of colour measurements in the dental clinic.

Background. The metabolic energy expenditure (MEE) was the most important assessment standard of intelligent prosthetic knee (IPK). Maximum swing flexion (MSF) angle and gait symmetry (GS) were two control targets representing different developing directions for IPK. However, the few comparisons based on MEE assessment between the MSF and GS limited the development of the IPK design. Objectives. The aim of the present work was to find out the MEE difference of amputees using IPK with control targets of MSF and GS and determine which target was more suitable for the control of IPK based on the MEE assessment. Methods. The crossover trial was designed. Six unilateral transfemoral amputees participated in the study. The amputees were assessed when wearing the IPK with different control targets, namely, the maximum swing flexion angle and gait symmetry. The oxygen consumption analysis during walking at different speeds on a treadmill was carried out. Results. All subjects showed increased oxygen consumption as walking speed increased. However, no statistically significant differences were found in oxygen consumption for different control targets. The ANOVA test showed that the overall effects of the control targets of the prosthetic knee on oxygen consumption were not significant across all walking speeds. Conclusions. The control targets of MSF and GS showed no significant differences on MEE in above-knee amputees using IPK. From perspective of amputee’s metabolic costs, either maximum swing flexion or gait symmetry could be suitable control target for the IPK.

Background Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains. Methods Fifty-seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six-months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost-consequence analysis (supply chain, clinician time, service use) and health status. Results At point of supply pressure reduction for the digital supply chain was non-inferior to a predefined margin and superior ( p  < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom-made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional − 13.85%, digital − 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains. Conclusions Custom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status. Trial registration Retrospectively registered on ISRCTN registry ( ISRCTN10978940 , 04/11/2015).

A new protocol for making an immediate provisional eyeglasses-supported nasal prosthesis is presented that uses laser scanning, computer-aided design/computer-aided manufacturing procedures, and rapid prototyping techniques, reducing time and costs while increasing the quality of the final product. With this protocol, the eyeglasses were digitized, and the relative position of the nasal prosthesis was planned and evaluated in a virtual environment without any try-in appointment. This innovative method saves time, reduces costs, and restores the patient's aesthetic appearance after a disfiguration caused by ablation of the nasal pyramid better than conventional restoration methods. Moreover, the digital model of the designed nasal epithesis can be used to develop a definitive prosthesis anchored to osseointegrated craniofacial implants.

ObjectivesThe purpose of this “first-in-man” study was to investigate the safety of a novel vascular polyester prosthesis coated with a resorbable polymer and free of any animal-based coating agents such as gelatin or collagen.MethodsIn a nonrandomized first-in-man multicenter safety study, the frequency of perigraft seroma (PGS) as the primary endpoint was studied in consecutive patients undergoing aortic reconstructions. The follow-up control to study the primary endpoint was intended at 3 months under routine clinical conditions. Pre- and postoperative white blood cell counts (WBC), C-reactive protein (CRP), and liver enzyme levels to characterize the systemic inflammation response and possible metabolic consequences were determined at different postoperative time points (secondary endpoints). Additionally, the primary unassisted patency rate, perioperative complications and serious adverse events, as well as intraoperative handling properties of the graft based on a semiquantitative scale were assessed. Magnetic resonance angiography (MRA) follow-up investigations were scheduled postoperatively at 3 months to determine graft tissue integration and the presence of PGS.ResultsA total of 24 patients with comorbidities such as coronary artery disease (8.3 %, 2/24), chronic occlusive pulmonary disease (COPD, 8.3 %, 2/24), Fontaine III/IV (20.8 %, 5/24), and diabetes (20.8 %, 5/24) were enrolled from June 2011 to September 2012. Due to two early nongraft-related deaths, there were 22 patients that had a follow-up. In these 22 patients, the freedom from PGS was 90.9 % (20/22) suggesting that the graft/tissue integration was comparable to other vascular grafts described in the relevant literature. WBC counts were not significantly different (pre (8.67 ± 2.98 1/nl) vs. follow-up (7.97 ± 2.24 1/nlI, p = 0.203). Likewise, preoperative CRP serum levels (6.47 ± 11.59 mg/l) were not different from those at follow-up (7.87 ± 12.81 mg/l, p = 0.769). There were two patients with a documented coagulation disorder and two premature deaths (cardiac failure, cerebral bleeding). The primary unassisted patency at follow-up was 77.3 % (17/22) in all patients who reached the follow-up (85.0 % or 17/20 if two cases with documented coagulation disorders are excluded). The reasons for occlusions were technical/surgical difficulties (2/5) and documented coagulation disorders (2/5). In one occlusion, the cause was unknown. There were no graft infections. Intraoperative graft handling properties were evaluated less favorable as compared to the routinely used gelatin- or collagen-coated polyester grafts in each investigator’s clinical practice.ConclusionsOur results suggest that Uni-Graft® Synthetic is a promising prosthetic vascular graft to reduce PGS. Our findings should be interpreted with caution noting the limitation of the lack of a control group.