Additive Manufacturing of Spinal Braces: Evaluation of Production Process and Postural Stability in Patients with Scoliosis.

Spinal orthoses produced using additive manufacturing show great potential for obtaining patient-specific solutions in clinical applications, reducing manual operations, time consumption, and material waste. This study was conducted to evaluate the production process of spinal orthoses produced by additive manufacturing, and to test the effects of 3D-printed braces on postural stability in patients with adolescent idiopathic scoliosis and osteogenesis imperfecta. Ten patients were recruited consecutively and were asked to wear a spinal orthosis produced by additive manufacturing for 2 weeks. The four phases of the production process for each brace were evaluated separately on a scale from 0 (not acceptable) to 3 (optimal). Postural stability in the unbraced and the two braced conditions (3D-printed and conventional) was assessed using validated metrics obtained from a wearable inertial sensor. The production process was evaluated as good in four cases, acceptable in five cases, and not acceptable in one case, due to problems in the printing phase. No statistically significant differences were observed in any of the postural balance metrics between the 3D-printed and conventional brace. On the other hand, postural balance metrics improved significantly with both types of braces with respect to the unbraced condition. Spinal orthoses produced with an innovative production process based on digital scans, CAD, and 3D printing are valid alternatives to conventionally produced orthoses, providing equivalent postural stability.

A Comparative Study for Material Selection in 3D Printing of Scoliosis Back Brace.

In recent years, many research studies have focused on the application of 3D printing in the production of orthopaedic back braces. Several advantages, such as the ability to customise complex shapes, improved therapeutic effect and reduced production costs place this technology at the forefront in the ongoing evolution of the orthopaedic sector. In this work, four different materials, two of them poly(lactic acid) (PLA) and two of them poly(ethylene terephthalate glycol) (PETG), were characterised from a thermal, mechanical, rheological and morphological point of view. Our aim was to understand the effects of the material properties on the quality and functionality of a 3D-printed device. The specimens were cut from 3D-printed hemi-cylinders in two different orientation angles. Our results show that PETG-based samples have the best mechanical properties in terms of elastic modulus and elongation at break. The PLA-based samples demonstrated typical brittle behaviour, with elongation at break one order of magnitude lower. Impact tests demonstrated that the PETG-based samples had better properties in terms of energy absorption. Moreover, 3D-printed PETG samples demonstrated a better surface finishing with a more homogenous fibre-fibre interface. In summary, we demonstrate that the right choice of material and printing conditions are fundamental to satisfy the quality and functionality required for a scoliosis back brace.

The high rate of spontaneous migration of small size common bile duct stones may allow a significant reduction in unnecessary ERCP and related complications: results of a retrospective, multicenter study.

INTRODUCTION: Common bile duct stones (CBDS) can spontaneously migrate through the duodenal papilla. In this case, ERCP could be unnecessary and a significant rate of complications could be avoided. In this study, we aim at retrospectively evaluating the rate of spontaneous stone passage in patients with an imaging diagnosis of CBDS and at analysing the factors associated to spontaneous stone migration. METHODS: We conducted a retrospective multi-centre analysis of patients undergoing ERCP for CBDS in a 12-month period. 1016 patients with CBDS were analysed. In all patients CBDS was diagnosed with adequate imaging methods performed prior to ERCP. ERCPs with failed biliary cannulation were excluded. Data regarding patients' characteristics, imaging findings and ERCP procedure were analysed. RESULTS: 1016 patients with CBDS undergoing ERCP were analysed (male sex 43.3%; mean age 69.9 ± 16.5 years). Diagnosis of CBDS was obtained by EUS in 415 patients (40.8%), MR in 343 (33.8%), CT in 220 (21.7%), and US in 38 (3.7%). No stones were found at ERCP in 179 patients (17.6%), in 14 (6.2%) when ERCP was performed within 6 h from imaging study, in 114 (18.5%) between 7 h and 7 days, in 32 (24.6%) between 8 and 29 days, and in 19 (43.2%) after 30 days. The rate of unnecessary ERCP occurred significantly more frequently in patients in whom imaging methods demonstrated either sludge or ≤ 5 mm CBDS (29.9 vs. 8.3%; p < 0.001). DISCUSSION: Spontaneous migration of small CBDS is a frequent event, and ≤ 5 mm size and a delay in ERCP > 7 days represent predictive factors for it. We suggest that CBDS ≤ 5 mm should not undergo immediate removal and this fact would allow reducing the rate of unnecessary ERCP with their related complications. Prospective studies are needed to confirm these results and demonstrate the safety of a conservative management in this setting.

Medical Device Development for Children and Young People-Reviewing the Challenges and Opportunities.

Development of specific medical devices (MDs) is required to meet the healthcare needs of children and young people (CYP). In this context, MD development should address changes in growth and psychosocial maturation, physiology, and pathophysiology, and avoid inappropriate repurposing of adult technologies. Underpinning the development of MD for CYP is the need to ensure MD safety and effectiveness through pediatric MD-specific regulations. Contrary to current perceptions of limited market potential, the global pediatric healthcare market is expected to generate around USD 15,984 million by 2025. There are 1.8 billion young people in the world today; 40% of the global population is under 24, creating significant future healthcare market opportunities. This review highlights a number of technology areas that have led to successful pediatric MD, including 3D printing, advanced materials, drug delivery, and diagnostic imaging. To ensure the targeted development of MD for CYP, collaboration across multiple professional disciplines is required, facilitated by a platform to foster collaboration and drive innovation. The European Pediatric Translational Research Infrastructure (EPTRI) will be established as the European platform to support collaboration, including the life sciences industrial sector, to identify unmet needs in child health and support the development, adoption, and commercialization of pediatric MDs.

Inflammatory bowel disease in a colorectal cancer screening population: Diagnosis and follow-up.

BACKGROUND: Inflammatory bowel disease (IBD) is usually diagnosed in subjects with gastrointestinal symptoms, but may also be asymptomatic and diagnosed incidentally. AIMS: to determine the prevalence of IBD in asymptomatic adults. METHODS: we identified subjects who underwent colonoscopy between 1 September 2013 and 31 August 2019 in a regional colorectal cancer screening program with endoscopic findings suggestive of IBD, and retrieved their clinical, histological and therapeutic information. RESULTS: 5116 subjects underwent colonoscopy, and 4640 persons were considered assessable. Of these, 54 (1.16%) had endoscopic findings suggestive of IBD, including 40 of Crohn's disease (CD) and 14 of ulcerative colitis (UC). A definite diagnosis of IBD was made in 19 patients, for an overall IBD prevalence of 0.41%, with 13 cases of CD (0.28%) and 6 of UC (0.13%). The mean follow-up was 26.8 months after the first colonoscopy. Therapy was started in 5 of 13 CD patients and all UC patients. CONCLUSION: Endoscopic findings suggestive of IBD are not infrequent in an asymptomatic colorectal cancer screening population. Visualization of the terminal ileum is recommended in this setting. A definite diagnosis of IBD was made in about 1 out of 3 subjects with endoscopic lesions. Most IBD patients had a mild form of disease, but some needed biologic therapy.

Learning My Way: A Pilot Study of Navigation Skills in Cerebral Palsy in Immersive Virtual Reality.

Purpose: Human navigation skills are essential for everyday life and rely on several cognitive abilities, among which visual-spatial competences that are impaired in subjects with cerebral palsy (CP). In this work, we proposed navigation tasks in immersive virtual reality (IVR) to 15 children with CP and 13 typically developing (TD) peers in order to assess the individual navigation strategies and their modifiability in a situation resembling real life. Methods: We developed and adapted to IVR an application based on a 5-way maze in a playground that was to be navigated to find a reward. The learning process, navigation strategies, and adaptation to changes were compared between participants with CP and their TD peers and correlated with visual-spatial abilities and cognitive competences. Results: Most participants with CP needed more attempts than TD participants to become proficient in navigation. Furthermore, the learning phase was correlated to visual-spatial memory but not with cognitive competences. Interestingly, navigation skills were comparable between groups after stabilization. While TD participants mainly relied on allocentric strategies based on environmental cues, egocentric (self-centered) strategies based on body motion prevailed in participants with CP. Furthermore, participants with CP had more difficulties in modifying their navigation strategies, caused by difficulties in executive processes beyond the visual-perceptual impairment, with an inefficient shift between implicit and explicit competences. Conclusions: The navigation abilities in participants with CP seem to be different from their TD peers in terms of learning and adaptation to new conditions; this could deeply affect their everyday life and ultimately participation and inclusion. A regular assessing and focused rehabilitative plans could help to better navigate the environment and affect self-perception.

Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding.

BACKGROUND: Acute gastrointestinal bleeding (AGIB) results in significant morbidity and mortality. Topical hemostatic products have been developed for endoscopic use to help in the management of difficult bleeding. Our aim was to demonstrate the ease of use, safety, and efficacy of PuraStat, a novel hemostat, to control AGIB. METHODS: We describe 77 patients (41 men) who were treated for acute upper and lower AGIB in a 2-year period. In 50 patients, bleeding occurred as a complication of a previous endoscopic procedure, predominantly endoscopic mucosal resection (EMR) and endoscopic retrograde cholangiopancreatography (ERCP); however, in the other 27 patients, it derived from peptic ulcers, angiodysplasia, cancers, and surgical anastomoses. Bleeding was spurting in 13 of the 77 patients and oozing in 64. PuraStat was used after the failure of at least two conventional hemostatic methods. RESULTS: A mean of 2.6 conventional hemostatic methods had been attempted prior to the application of PuraStat. PuraStat achieved successful hemostasis in 90.9 % of patients. In 41 patients, once hemostasis was obtained with PuraStat, endoscopists further stabilized hemostasis by using at least one additional method. Recurrence of bleeding was observed in eight patients (10.4 %). In 16 patients with intraprocedural bleeding, it was possible to complete the procedures (14 EMR, 2 ERCP) after PuraStat hemostasis. No adverse events related to PuraStat were recorded. CONCLUSIONS: PuraStat is feasible, safe, and effective in controlling different types of gastrointestinal hemorrhage after failure of conventional hemostatic methods. Its application also does not hinder continuing endotherapy.

Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial.

BACKGROUND: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). METHODS/DESIGN: The study is an interventional randomised controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental group or the active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates in a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by eight 45-min sessions and are administered in the GRAIL VR laboratory (Motekforce Link, Netherlands), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) of the two trainings (T1) and at the end (T2). Moreover, a battery of neurocognitive tests spanning different domains is administered to all participants at T0, T2 and in a follow-up session after 2 months from the end of the two trainings (T3). DISCUSSION: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new, intensive, social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN 22332873. Retrospectively registered on 12 March 2018.

Efficacy of withdrawal time monitoring in adenoma detection with or without the aid of a full-spectrum scope.

Background and study aims Withdrawal time (WT) monitoring and full-spectrum endoscopy (FUSE) have been suggested to increase adenoma detection rate (ADR) due to more accurate evaluation of the hidden areas of the colon. We aimed to evaluate the efficacy of WT monitoring and FUSE on ADR. Patients and methods This was a prospective observational study involving consecutive outpatients, aged 18 to 85 years, undergoing colonoscopy with unselected indications. In phase 1, endoscopists performed 660 colonoscopies either with standard forward-viewing endoscope (SFVE) (n = 330) or with FUSE (n = 330). In this phase, WTs were measured without endoscopist awareness of being monitored. In phase 2, endoscopists were informed of being monitored and performed additional 660 colonoscopies either with SFVE (n = 330) or with FUSE (n = 330). Results WT was lower in phase 1 compared to phase 2 (SFVE: 269 ±â€Š83 vs. 386 ±â€Š60 sec, P  < 0.001; FUSE: 289 ±â€Š97 vs. 403 ±â€Š65 sec, P  < 0.001). Use of FUSE increased ADR both in phase 1 (33.0 % vs. 27.3 %, P  = 0.127) and in phase 2 (41.8 % vs. 33.6 %, P  = 0.037). When endoscopists were aware of being monitored, ADR was higher in SFVE (33.6 % vs. 27.3 %; P  = 0.090) and FUSE arms (41.8 % vs. 33.0 %; P  = 0.024). Improvement in detection of proximal adenomas was associated with WT monitoring [OR 1.577 (95 % C. I. 1.158 - 2.148); P  = 0.004], whereas detection of distal adenomas was associated with use of FUSE [OR 1.320 (95 % C. I. 1.022 - 1.705); P  = 0.037]. Conclusions Unmonitored endoscopists have suboptimal WT, which increases when they are monitored. WT monitoring and use of FUSE are two reliable and alternative strategies to increase ADR.

Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial.

BACKGROUND: Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing. AIMS: to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen. METHODS: Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing. RESULTS: Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment. CONCLUSIONS: The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).

Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program: the SMART (Study Methodology for ADR-Related Technology) trial.

BACKGROUND AND AIMS: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. METHODS: Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms. RESULTS: Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3%; mean AADR, 25.4%), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95% CI, 0.97-2.10) or per-patient analysis (24% vs 26%; P = .76). CONCLUSIONS: No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.).

Systematic review: Features, diagnosis, management and prognosis of hepatic hematoma, a rare complication of ERCP.

BACKGROUND: Hepatic hematoma (HH) is a rare but severe adverse event following endoscopic retrograde cholangiopancreatography (ERCP). AIMS: To perform a systematic literature review and describe two additional cases, one of which presenting multiple subcapsular/intrahepatic hematomas after ERCP. METHODS: The literature review was performed in PubMed/MEDLINE, EMBASE, and SCOPUS to identify all cases reporting on HH after ERCP. RESULTS: A total of 48 cases (females 63%, mean age 58.2 ±â€¯20.6 years) were included. The mean symptoms onset time was 46.8 h after ERCP, and the most common symptoms were abdominal pain (91.7%), anaemia (43.8%), hypotension (29.2%) and fever (20.8%). All cases were diagnosed by computed tomography (CT). HH was found mostly in the right hepatic lobe (95.1%) and the mean size was 116 × 93 mm. A conservative management was adopted in 38.3% of cases, while percutaneous drainage, embolization and surgery were needed in 31.9%, 14.9% and 25%. Mortality rate was about 9%. Anaemia (OR 6.9; p = 0.02) and surgery (OR 10.5; p < 0.01) were the only independent factors for unfavorable outcome (death), while abdominal pain (OR 0.1; p = 0.03) and antibiotics administration (OR 0.06; p < 0.001) were associated with better outcome. CONCLUSIONS: HH is a rare but severe complication following ERCP which needs a multidisciplinary approach. Antibiotics administration is the only treatment able to reduce the risk of death.