Si-Bone ((SIBN)) announced an update on their ongoing clinical study.
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The study titled ‘Innovative Spinopelvic Solutions with Real-World Evidence’ aims to evaluate post-operative health outcomes in patients undergoing procedures using SI-BONE implants. This research is significant as it seeks to provide real-world evidence on the effectiveness of these implants in treating sacroiliac joint dysfunction and pain.
The intervention being tested involves the use of health questionnaires, such as the numerical rating scale and Oswestry Disability Index, to assess patient outcomes following the use of SI-BONE implants. These questionnaires are designed to gather data on the effectiveness of the treatment from the patient’s perspective.
This observational study follows a cohort model with a prospective time perspective, meaning it observes a group of patients over time to assess outcomes. There is no random allocation or masking involved, and the primary purpose is to gather observational data on the implants’ effectiveness.
The study began on November 22, 2024, with the last update submitted on December 19, 2024. These dates are crucial as they indicate the study’s current status and progress, with the primary completion and estimated completion dates yet to be announced.
The update on this study could positively impact SI-BONE’s stock performance by boosting investor confidence in the company’s products, especially if the results demonstrate significant improvements in patient outcomes. This could also influence the competitive landscape, as positive real-world evidence might set SI-BONE apart from competitors in the medical device industry.
The study is currently ongoing, with further details available on the ClinicalTrials portal.