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The study was terminated prematurely due to the inability to collect retrospective clinical data within the required contractual and regulatory deadlines. Although ethical approval was obtained, data collection was not performed.
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| Name | Class |
|---|---|
| Hospital dos LusÃadas | OTHER |
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This study aims to collect real-world clinical data to gather information on the performance and safety of the TriOSS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.
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| Measure | Description | Time Frame |
|---|---|---|
| Performance Endpoint | the success of bone consolidation on the surgery site, measured by X-ray. This includes radiological assessments (X-rays) to prove bone regeneration and assess the time required for bone consolidation. | Follow-up visits according to clinical practice and medical records: months post-surgery until a maximum of 24 months |
| Safety Endpoint | Assessment of AEs related to TriOSS® during the follow-up period of patients. Description of the event type, duration, determination of Serious Adverse Event (SAE) status, and follow-up of the adverse event. | Follow-up visits according to clinical practice and medical records, months post-surgery, until a maximum of 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients (> 18 years old) undergoing orthopaedic surgery after bone defect.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital LusÃadas Lisboa | Lisbon | Portugal |
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