View clinical trials related to Deformity.
Filter by:The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49).
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of equivalent devices. This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JPS in a representative population of Patients and users. The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JPS with real-word-evidence clinical data, in order to confirm the benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements.
This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.
It has been reported that the head protrudes forward relative to the body from the sagittal plane associated with the anterior shifting of the line of gravity (LOG) relative to the base of support (BOS). On the other hand, the center of gravity (COG) has changed with the forward head posture (FHP) and is related to mechanical and musculoskeletal modifications due to postural control, which affects the whole body balance. Griegel-Morris et al. Reported that, after evaluating eighty-eight healthy participants, 66% had a forward head posture (FHP). In addition, he stated that the inverted head posture in the forward head posture will not only cause neck problems, but also can extend to the shoulder joint and thoracic spine. As a result, it causes a general imbalance in the musculoskeletal system. Jung-Ho Kang and his colleagues examined the effect of daily sitting times of computer users on dynamic and static balance and stated that balance ability decreased in heavy computer users. Another study on forward head posture (IBP) revealed that it limits ankle joint movement, especially in ankle plantarflexion.
Neuromuscular diseases caused by disruption of the normal conduction relationship between nerve system, neuromuscular junction, and muscles cause scoliosis as a secondary deformity. Neuromuscular scoliosis progresses due to muscle weakness and characteristic features of disease. The risk of complications associated with increased progression. Morbidity and mortality caused by scoliosis in neuromuscular diseases can be reduced by increasing the knowledge and awareness of the caregivers and physiotherapists. In this study, it was aimed to determine the risk of neuromuscular scoliosis and the factors which can cause in children with disabilities. It is also aimed to reveal inferences related to education levels, awareness of caregivers and professionals working in this field to determine cases with a high risk of scoliosis. Thus, it is expected to leading future research to develop preventive treatment approaches. For this purpose, 288 children who are diagnosed with the neuromuscular disease between 3-18 years of age, attending Rehabilitation Center in Istanbul and willing to participate in the research permitted by their caregiver will be included in this study. Cerebral Palsy Follow-Up Program (CPUP), Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis which is prepared by researchers, Early Onset Scoliosis 24 Questionnaire, Scoliosis Research Society 22 Questionnaire to assess QoL, demographic and clinical data also will collect for all sample. Patients will be examined for musculoskeletal system, scoliosis analysis will be performed radiologically. Data obtained to determine the problems, risk factors, and awareness of the caregivers and physiotherapists will be analyzed statistically.
There is a robust body of research suggesting that the use of pre-surgical orthopedic devices prior to definitive cleft lip/nose repair results in significant improvement of facial aesthetics with long term follow up. However, in recent surveys of the cleft centers in the US, only 30% of cleft centers offer PSIOs, and only 13% routinely report its use. Accordingly, thirty percent of centers utilize a two-stage cleft lip/nose repair in the centers' algorithm (1st: lip adhesion; 2nd: final lip repair). The major drawback to a two-stage cleft procedure is the administration of two general anesthetics to an infant before the age of one year. There is a growing amount of evidence that multiple anesthetic experiences before a certain age could affect brain development. It is difficult to make inferences as to why clinicians are not utilizing surgical aids to decrease the size of the cleft width, but even when PSIO is offered, caregivers experience additional, potentially prohibitive challenges. In one study, caregivers traveled an average of 70 miles to visit the nearest cleft center offering pre-surgical orthopedic devices. As these devices are created by hand every 1-2 weeks after seeing the child in clinic, parents are required to travel to clinic multiple times per month. Not surprisingly, infants who were first-born and those who did not have other siblings were more likely to receive pre-surgical orthopedic treatment than infants who were residing with other siblings. Given the benefits of PSIOs and the barriers both to healthcare systems and patients' families associated with PSIOs in its current form, a new form of pre-surgical clinical management is needed. Objectives: 1. Evaluate JHH's current clinical performance in addressing unilateral cleft lip and nasal deformity. 2. Elucidate the difference in preoperative cleft size and in surgical management/outcomes for patients who received PSIOs through 3D-printed devices. 3. Using the above maxillofacial growth data with and without PSIOs, the investigators aim to create an algorithm to predict maxillofacial growth for each individual patient to design pre-sequenced custom PSIO devices.
Assessment of accuracy of correction of genu varum more than 20 degrees using external fixator assisted plating. Intraoperatively, the operative time needed for completion of accurate correction, torniquet use, blood loss will be assessed. Postoperative complications either early ones like infection, thromboembolic complications, peroneal nerve palsy or late post operative complications like implant failure, delayed union, non union and bone healing time will be assessed..
The aim of this study is to investigate the efficiency of an exercise program based on principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic patients.
The CT examination on IQon Spectral CT would be a standard of care CT performed as per the clinical indication. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced. And therefore, the primary study aim is to assess the impact of IQon Spectral CT scanner and applications on the clinical workflow of the site as well as the diagnostic confidence levels of the physicians reading the CT cases. In addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning protocols, optimization of reconstruction parameters; evaluate the utility of iodine maps and other supported materials.