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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a long-term observational study to collect consistent clinical data from children and adults who have cochlear implants, specifically those with MED-EL CI systems. The goal is to better understand the clinical effectiveness of cochlear implants over time by using standardized measures and procedures across different clinics, which has been a challenge in past research. Participants will receive cochlear implant treatment as part of their usual clinical care without any changes or experimental interventions from the study. The study uses a secure, cloud-based platform to collect anonymized clinical data at regular intervals, facilitating the comparison of hearing and auditory development outcomes over time. During the study, researchers will gather data on hearing thresholds, quality of hearing in adults, and auditory development in children using various assessment tools such as CAP, SIR, and LEAQ over a five-year period. This data collection is non-interventional and follows participants through their standard care, with the aim of monitoring outcomes and observing long-term trends in cochlear implant performance.
Actively Recruiting
Researchers are conducting an international multicenter prospective observational study focused on patients with symptomatic, radiologically confirmed single- or multilevel contiguous thoracolumbar T1 to L5 fractures caused by primary osteoporosis. The study includes both insufficiency fractures confirmed by MRI and low-energy traumatic fractures confirmed by CT or MRI. It aims to evaluate how well the Osteoporotic Fracture OF classification-based scoring system guides treatment decisions for these fractures, comparing outcomes when treatment aligns or does not align with the OF score recommendations. Participants will be classified using the OF system from OF 1 to OF 5 based on the severity of their fractures. Treatment decisions are categorized as either nonsurgical or surgical, with patients grouped according to whether their treatment matches the OF score guidance Accordance group or differs from it Discordance group. The initial treatment decision day is designated as Day 0, and patients will be followed clinically at discharge, 6 weeks, 3 months, 6 months, and 12 months. Surgical interventions may include various types of posterior stabilization procedures with or without augmentation or osteotomy. During the study, participants will undergo assessments to measure their return to mobility, which is the primary outcome within the first 3 months after treatment. Secondary outcomes include evaluations of clinical status, pain levels, daily activities, quality of life, and complications related to surgery or fracture subtype over a 12-month period. Researchers will collect data through clinical follow-ups at specified intervals, tracking treatment type, functional recovery, and patient satisfaction. The total follow-up duration extends up to one year to monitor long-term results and health economic impacts.