Study Design. Randomized controlled trial. Objective. To compare the effectiveness of the automated pressure-adjustable orthosis (PO) and conventional orthosis (CO) for treatment of adolescent idiopathic scoliosis (AIS). Summary of Background Data. Orthosis wearing quality may influence its effectiveness for AIS. An automated PO aimed to provide a more optimized and consistent biomechanical environment. Clinical evaluation was conducted to study the effectiveness of this innovative orthosis. Methods. Patients with AIS who met the criteria (Age 10–14, Cobb 20°–40°, and Risser sign 0–2) were recruited from two clinics and randomly assigned to the PO and CO groups. Compliance sensors were embedded in both groups, while the PO group was set to adjust the interfacial pressure as prescribed automatically. Clinical assessments (radiology and quality of life, QoL) were conducted at the baseline, immediate after orthosis fitting and 1-year follow-up. Orthosis wearing compliance was tracked using thermo and pressure sensors. Results. Twenty-four patients were enrolled with one drop-out (PO, n = 11; CO, n = 12). Significant immediate in-orthosis correction was observed in the PO (11.0° ± 6.5°, 42.0%, P < 0.001) and CO (10.3° ± 5.3°, 37.6%, P < 0.001) groups. After 1 year, no patient with PO progressed while two with CO had progression more than 5°. The mean daily wearing duration was 1.1 hours longer in the PO group as compared with the CO group (15.4 ± 4.5 vs. 14.3 ± 3.8 h). Moreover, the wearing quality within the targeted pressure was 33.9% higher in the PO group (56.5 ± 16.5% vs. 23.1 ± 12.1%, P < 0.001). No significant difference in the QoL results was observed between two groups nor within both groups during the study period. Conclusion. This study showed that the automated PO could enhance wearing quality when compared with the CO, thus offering a better biomechanical corrective effect in the study period without adverse effect on the patients’ wearing quantity and QoL. Level of Evidence: 1
Study Design. Prospective randomized controlled trial. Objective. To compare clinical effectiveness and quality of life (QoL) of the 3D-printed orthosis (3O) and conventional orthosis (CO) for adolescent idiopathic scoliosis (AIS). Summary of Background Data. Using 3D printing technology to design and fabricate orthoses to manage AIS aiming to improve in-orthosis correction and patients' compliance that are considered essential factors of effective treatment. Clinical evaluation was conducted to study the effectiveness of this innovative method. Methods. Thirty females with AIS who met the criteria (age 10-14, Cobb 20-408, Risser sign 0-2, 12 months after menarche) were recruited. Subjects were randomly allocated to the 3O group (n ¼ 15, age 12.4, Cobb 31.88) and CO group (n ¼ 15, age 12.0, Cobb 29.38). All patients were prescribed for full-time wearing (23 hours/d) and follow-up every 4 to 6 months until bone maturity. Compliance was monitored by thermosensors, while QoL was assessed using three validated questionnaires. Results. Comparable immediate in-orthosis correction was observed between 3O (À11.68, P < 0.001) and CO groups (À12.98, P < 0.001). In the QoL study via SRS-22r, the 3O group got worse results after 3 months in aspects of function, selfimage, and mental health (À0.5, À0.6, À0.7, P < 0.05) while the CO group had worse results in aspects of self-image and mental health (À0.3, À0.3, P < 0.05). No significant difference was found in QoL assessments between groups. After 2 years of follow-up, 22 patients were analyzed with 4 dropouts in each group. Comparable angle reduction was observed in both groups (3O: À2.28, P ¼ 0.364; CO: À3.58, P ¼ 0.193). There was one subject (9.1%) in the 3O group while two subjects (18.2%) in the CO group had curve progression >58. Daily wearing hours were 1.9 hours longer in the 3O group than the CO group (17.1 vs. 15.2 hours, P ¼ 0.934). Conclusion. The 3O group could provide comparable clinical effects as compared with the CO group while patients with 3O showed similar compliance and QoL compared to those with CO.
IntroductionRecently the EOS imaging system (EOS Imaging, Paris, France) has provided advancements in 3D spinal modeling. Advancements include low radiation as well as fast and accurate reconstructed measurements of spinal parameters. There is a paucity of studies analyzing the reproducibility of the EOS Imaging System and the sterEOS software in the production of 3D spinal models for children with adolescent idiopathic scoliosis (AIS). Objectives The purposes of the study were 1) to determine the intraclass correlation (ICC) for both the inter-observer and intra-observer in the measurements of Cobb angles in AP view as well as the Cobb angles in the lateral view; 2) to assess the ICC for inter-and intra-observer in the axial vertebral rotation (AVR) of the apex vertebra; 3) to compare differences of spinal parameters between two examiners and two trials; 4) to determine how long a 3D reconstruction of the spine takes. Methods Bilateral x-ray images of fifteen patients (age: 6 -15 years old, 5 males, 10 females) were retrospectively selected. These EOS images were uploaded into the sterEOS computer program. Within the software, spinal and pelvic parameters were identified manually to construct a 3D model of the spine. The sterEOS software calculates the Cobb angles, angles of lordosis, angles of kyphosis, and the AVRs of the apex vertebra. The 3D modeling was performed independently by two examiners. Each examiner modeled each patient's spine in two spaced out trials. The ICC between inter-and intra-observers were calculated and compared statistically. Results and discussionBoth the inter-and intra-observers showed excellent reproducibility for the Cobb angles in the proximal segment (ICC: 0.72 -0.91), kyphosis (ICC: 0.85-0.92), and lordosis (ICC: 0.82 -0.95). No significant differences were found between angle differences (0.35°to 2.4°). In contrast to the traditional radiography, the sterEOS provides a better high quality view within the sagittal plane. A moderate inter-observer ICC for the Cobb angle in the distal segment (ICC = 0.67) indicates the examiners have to carefully adjust the alignment and vertebrae in 3D rather than in 2D following the automatic computation from the EOS software. The interobserver ICC for the AVR in the lumbar region (0.80) is higher than the thoracic or thoracolumbar region (0.65), but with high differences of AVR (4.0°-6.3°). The average time that two examiners spent per subject ranged from 34.6 to 37.4 minutes. Conclusion and significance EOS provides significantly reliable and accurate spinal modeling in the measurement of children with AIS. Exposure to less radiation as compared to other radiographic modality allows EOS to offer acceptable quality view of the spine in the sagittal and transversal plane. sagittal balance and predictive equations to determine lumbopelvic compensatory patterns (LPCP). These equations are used to guide surgical decision making and technique selection. Although other lumbopelvic compensation equations are available, these have not been compared wi...
Background:Hip protectors have been widely used for hip fracture prevention in the elderly, but its efficacy remains controversial. Users' compliance to hip protector is an important factor for its efficacy. However, the assessment of users' compliance tended to be subjective and unreliable in the past.Objectives:To quantify the elderly's compliance to hip protectors and investigate the effect of different underpant designs on the elderly's compliance.Study Design:A pilot randomized trial.Methods:Thirty-one participants were recruited and provided with hip protectors in which compliance monitors were installed and delivered with three pairs of either the conventional underpants or the purpose-design underpants randomly. Participants were encouraged to use the hip protectors with the assigned underpants for whole day. After 4 weeks, compliance data were downloaded from the compliance monitors. Participants were also asked to fill a survey form for acceptance analysis. The Spearman correlation coefficient and the Wilcoxon signed-rank test/2 independent samples t test/Mann-Whitney U test were used for the corresponding statistical analyses.Results:Thirty-one participants were recruited initially. Eighteen participants were excluded from instrumented compliance analysis because of limited or no data collection. The data of the resting 13 participants (six in the conventional underpants group and seven in purpose-design underpants group) were analyzed and showed an average instrumented compliance of 77.5% which was lower than the average self-reporting compliance (83.3%) of all the available 23 participants (eight of 31 became wheelchair-bounded). Participants' compliance was positively correlated with their acceptance to the hip protectors and significantly higher in the purpose-design underpants group than in the conventional underpants group (P < 0.05).Conclusions:This pilot study demonstrated a feasible protocol for compliance quantification of the elderly to the hip protectors, the importance to have an objective compliance measure to assess users' actual compliance, and purpose-design underpants could improve the users' compliance. Future studies with long-term observation and large sample size deserve further proof of the current findings.
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