Force Characterization and Manufacturing of a Dynamic Unilateral Clubfoot Brace

Clubfoot is a musculoskeletal birth defect that is characterized by an inward twisting of an infant’s feet. The current method for correction involves several casts and a bilateral boots-and-bar maintenance brace. This method of maintenance requires 5 years of bracing and has issues with compliance, comfort, and social stigma. CURE International in Kijabe, Kenya is currently using the boots-and-bar brace but is interested in implementing a design that reduces these concerns. Mr. Jerald Cunningham, CPO, designed and is utilizing a unilateral clubfoot maintenance brace, the Cunningham Brace, which he expects will reduce treatment time to 2-3 years, lessen the social stigma, and increase the child’s mobility. However, there is not enough published research on its biomechanics and patient success rates to confirm his findings. The Collaboratory Cunningham Clubfoot Brace project seeks to validate the effectiveness of this design and increase accessibility through force testing and standardized manufacturing. We are working on measuring the biomechanical forces created and applied by the brace with a series of force sensors that are attached to the child’s brace. In addition, a new wrapping process for manufacturing the Cunningham Brace is being developed to increase the productivity and reproducibility of brace manufacturing in Kenya. Along with a clinical study that was started in Kenya, this testing and manufacturing will allow for further understanding of the effectiveness of the Cunningham Brace and provide more research for the medical community for it to potentially be accepted as an alternative clubfoot maintenance brace.https://mosaic.messiah.edu/engr2020/1014/thumbnail.jp

The Quality of Registration of Clinical Trials

BACKGROUND: Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. METHODS AND FINDINGS: A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. CONCLUSIONS: Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records

Comparison of fixed and mobile-bearing total knee arthroplasty in terms of patellofemoral pain and function: a prospective, randomised, controlled trial

Abstract Background Despite growing evidence in the literature, there is still a lack of consensus regarding the use of the mobile-bearing (MB) design total knee arthroplasty (TKA). Methods In a prospective, comparative, randomised, single centre trial, 106 patients with end-stage osteoarthritis of the knee were randomised to either an MB or fixed-bearing (FB) group to receive posterior stabilised (PS)-TKA using a standard medial parapatellar approach and patellar resurfacing with follow-up (FU) for 5 years. The primary outcome was anterior knee pain (AKP) during the chair rise test and the stair climb test 5 years after surgery. The secondary outcome was the ability to rise from a chair and to climb stairs, range of motion (ROM), Knee Society Score (KSS), RAND-36 scores and radiological analysis of the patellar tilt. Results No statistically significant difference was found between the two groups at 5 years FU in terms of median AKP during the chair rise test and the stair climb test (p = 0.5 and p = 0.8, respectively). There was no significant difference in any of the other secondary outcome parameters between the groups at 5 years FU. Conclusion A mobile-bearing TKA does not decrease AKP compared to fixed bearings. Trial registration number ClinicalTrials.gov NCT02892838 . Level of evidence I

Imaging of abdominal hernias

Abdominal hernias are a common clinical problem. The main types of abdominal hernias are external or abdominal wall hernias, which involve protrusion of abdominal contents through a defect in the abdominal wall; internal hernias, which involve protrusion of viscera through the peritoneum or mesentery and into a compartment in the abdominal cavity; and diaphragmatic hernias, which involve protrusion of abdominal contents into the chest. Clinical diagnosis of abdominal hernias can be difficult. However, plain radiography, radiography performed after administration of barium, and computed tomography allow evaluation of suspected abdominal hernias and detection of those that are clinically occult. The anatomic location of the hernia, the contents, and complications such as incarceration, bowel obstruction, volvulus, and strangulation can be demonstrated with radiologic examination. Occasionally, complications such as neoplasms or inflammatory conditions can be identified in the hernial contents. With abdominal imaging modalities, a variety of abdominal hernias can be confidently diagnosed

Accuracy of the Precision Saw versus the Sagittal Saw during total knee arthroplasty: A randomised clinical trial

Background The aim of this study was to compare the accuracy of the oscillating tip saw system (Precision Saw = PS) with the more conventional fully oscillating blade system (Sagittal Saw = SS) during computer-assisted total knee arthroplasty (CAS-TKA). Methods A prospective, randomised, controlled trial included 58 consecutive patients who underwent primary CAS-TKA and were randomly assigned in the PS group or the SS group to compare the accuracy of both blades. The primary outcome was the difference between the intended cutting planes and the actual cutting planes in degrees (°) in two planes of both the femur and the tibia. The secondary outcome was total surgery time. Results Tibia: In the VV-plane no significant differences were registered for the mean absolute deviation (p = 0.28). The PS was more accurate in the AP-plane (p = 0.03). Femur: The PS showed significantly fewer mean absolute deviations in the VV-plane (p = 0.03); however, the SS revealed better accuracy in the FE-plane (p = 0.04). The difference in the surgery time between the groups was not statistically significant (p = 0.45). Two outliers were measured using the SS, while seven outliers were detected using the PS. Conclusion The Precision Saw is not proven to be overall more accurate than the Sagittal Saw. Significantly better accuracy was shown with the PS in the two cutting planes, with the exception of one cutting plane that favoured the SS. Greater number of outliers were found using the PS. Level of evidence: I