Malle

Researchers are evaluating the safety and performance of the ORIGIN4 CR devices and associated instruments in patients needing total knee replacement. This study is a prospective, non-randomized, single-arm, observational post-market study. It aims to assess safety by measuring the rate of patients needing revision surgery one year after the procedure, and performance by using the Knee Society Score (KSS) for knee function and patient satisfaction over one and two years. In this study, 199 patients will be treated with the ORIGIN4 CR device. Enrollment will occur over 18 months, during which eligible patients will receive the device as part of their knee replacement surgery. Patients will then be followed for 24 months to monitor outcomes. The study expects patients to experience improved natural feel of the prosthesis in the first year and further improvement in satisfaction by the second year. Participants will be evaluated at multiple follow-up visits including assessments of knee function using the KSS scores at one year and two years post procedure. Safety is monitored by tracking the need for revision surgeries within one year. Patients must be willing and able to return to the implanting site for these visits. Overall, the study tracks both clinical performance and patient satisfaction over a two-year period.

For some time now, patient compliance with paper bladder diaries is being questioned. Paper bladder diaries are often incomplete, unreliable and/or of low quality. Multiple electronic bladder diaries have been developed to overcome some of the limitations associated with paper bladder diaries. However, based on several comparison studies between paper and electronic bladder diaries, it is not clear whether an electronic format alone is truly superior to the paper format. The investigators want to introduce and evaluate the feasibility of a new type of bladder diary: an automated bladder diary. In contrast to an electronic diary, an automated diary automatically registers voiding data using a connected measuring device. An electronic diary simply eliminates the use of paper, but the patient still needs to measure the voided volumes with a urinary container and manually enter them in the electronic diary. The investigators believe an automated diary may lead to improved patient compliance by reducing the required efforts from the patient and instead provide guidance and prompts.

Researchers are collecting data in Flanders on how often suicide attempts and suicidal thoughts occur across various healthcare settings like hospitals, psychiatric centers, crisis teams, and general practitioners. The study aims to understand the methods used in suicidal behavior and see how many people receive proper aftercare following a suicide attempt. It uses a detailed tool called the Guideline for Suicide Care and Evaluation (LOES) to gather comprehensive information about individuals with suicidal thoughts or behaviors. The study includes a two-part semi-structured interview conducted by trained healthcare professionals such as nurses, psychologists, and psychiatrists. The first part happens shortly after admission to a healthcare facility following a suicide attempt or suicidal thoughts and collects demographic data, history, social support, hopelessness levels, and current suicidal ideation. The second part explores psychological factors more deeply, including motives, personal and interpersonal problems, and current thoughts of self-harm or suicide. Participants undergo detailed assessments on the first day covering demographics, clinical details, suicidal behavior methods, emotional state, suicidal intent and planning, past self-harm, social support, mental health history, substance use, coping strategies, and care needs. The study tracks participants’ openness to help and care pathways to formulate well-supported risk assessments. This comprehensive evaluation helps understand suicidal processes and needs in the Flanders region.